A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

June 12, 2025 updated by: Bristol-Myers Squibb

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
729

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Local Institution - 0200
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Local Institution - 0048
      • San Isidro, Buenos Aires, Argentina, 1642
        • Local Institution - 0038
    • Distrito Federal
      • Caba, Distrito Federal, Argentina, C1015
        • Local Institution - 0039
    • Tucuman
      • San Miguel de Tucumán, Tucuman, Argentina, 4000
        • Local Institution - 0171
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Local Institution - 0003
      • Paramatta, New South Wales, Australia, 2150
        • Local Institution - 0018
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Local Institution - 0004
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Local Institution - 0099
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Local Institution - 0002
      • Geelong, Victoria, Australia, 3220
        • Local Institution - 0017
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0078
      • Gent, Belgium, 9000
        • Local Institution - 0058
      • Liège, Belgium, 4000
        • Local Institution - 0061
  • Canada
      • Quebec, Canada, G1V 3M7
        • Local Institution - 0001
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Local Institution - 0111
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Local Institution - 0006
      • Markham, Ontario, Canada, L3P 1X3
        • Local Institution - 0030
      • Toronto, Ontario, Canada, M5T 2S6
        • Local Institution - 0036
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Local Institution - 0126
    • Beijing
      • Beijing, Beijing, China, 100083
        • Local Institution - 0152
      • Beijing, Beijing, China, 100730
        • Local Institution - 0146
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Local Institution - 0153
      • Guangzhou, Guangdong, China, 510317
        • Local Institution - 0135
      • Shenzhen, Guangdong, China, 518020
        • Local Institution - 0206
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Local Institution - 0127
    • Hunan
      • Changsha, Hunan, China, 410008
        • Local Institution - 0170
      • Changsha, Hunan, China, 410011
        • Local Institution - 0161
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Local Institution - 0125
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0138
      • Nantong, Jiangsu, China, 226001
        • Local Institution - 0139
      • Wuxi, Jiangsu, China, 214023
        • Local Institution - 0163
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • Local Institution - 0148
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0131
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0156
      • Pingxiang, Jiangxi, China, 337055
        • Local Institution - 0140
    • Neimeng
      • Baotou, Neimeng, China, 014010
        • Local Institution - 0158
      • Hohhot, Neimeng, China, 010050
        • Local Institution - 0157
    • Shan3xi
      • Xi'An, Shan3xi, China, 710004
        • Local Institution - 0154
    • Shanghai
      • Shanghai, Shanghai, China, 200052
        • Local Institution - 0207
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Local Institution - 0164
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Local Institution - 0117
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Local Institution - 0134
    • Zhejiang
      • Wenzhou, Zhejiang, China, 32500
        • Local Institution - 0129
  • Colombia
      • Bogotá, Colombia, 110221
        • Local Institution - 0015
      • Cali, Colombia, 760035
        • Local Institution - 0020
      • Chía, Colombia, 250001
        • Local Institution - 0022
      • Medellin, Colombia, 50036
        • Local Institution - 0019
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Local Institution - 0072
  • Czechia
      • Brno, Czechia, 638 00
        • Local Institution - 0010
      • Ostrava, Czechia, 702 00
        • Local Institution - 0009
      • Ostrava, Czechia, 702 00
        • Local Institution - 0035
      • Praha 2, Czechia, 12850
        • Local Institution - 0011
      • Uherske Hradiste, Czechia, 686 01
        • Local Institution - 0023
  • Germany
      • Erlangen, Germany, 91054
        • Local Institution - 0199
      • Hamburg, Germany, 20095
        • Local Institution - 0046
      • Köln, Germany, 50937
        • Local Institution - 0101
      • Magdeburg, Germany, 39120
        • Local Institution - 0075
      • Minden, Germany, 32429
        • Local Institution - 0201
      • Tübingen, Germany, 72076
        • Local Institution - 0074
    • Nordrhein-Westfalen
      • Ratingen, Nordrhein-Westfalen, Germany, 40878
        • Local Institution - 0176
  • Hungary
      • Budapest, Hungary, 1062
        • Local Institution - 0197
      • Debrecen, Hungary, 4032
        • Local Institution - 0066
      • Gyula, Hungary, 5700
        • Local Institution - 0028
      • Hódmezővásárhely, Hungary, 6800
        • Local Institution - 0024
      • Kistarcsa, Hungary, 2143
        • Local Institution - 0027
    • Veszprém City
      • Veszprem, Veszprém City, Hungary, 8200
        • Local Institution - 0025
  • Italy
      • Firenze, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi-Reumatologia
      • Potenza, Italy, 85100
        • AOR San Carlo di Potenza-UOC Reumatologia
      • Roma, Italy, 00168
        • Local Institution - 0097
  • Japan
      • Fukuoka, Japan, 814-0180
        • Local Institution - 0155
      • Osaka, Japan, 545-8585
        • Local Institution - 0166
      • Osaka, Japan, 550-0006
        • Local Institution - 0204
    • Aichi
      • Nagoya, Aichi, Japan, 457-8511
        • Local Institution - 0202
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution - 0106
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0151
    • MIE
      • Tsu, MIE, Japan, 514-8507
        • Local Institution - 0179
    • Osaka
      • Kawachinagano, Osaka, Japan, 586-8521
        • Local Institution - 0123
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Local Institution - 0205
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Local Institution - 0121
      • Itabashi-ku, Tokyo, Japan, 173-0003
        • Local Institution - 0067
      • Meguro-ku, Tokyo, Japan, 1538515
        • Local Institution - 0178
      • Minato-ku, Tokyo, Japan, 105-8471
        • Local Institution - 0122
      • Mitaka, Tokyo, Japan, 181-8611
        • Local Institution - 0174
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Local Institution - 0065
  • Mexico
      • Chihuahua, Mexico, 31203
        • Local Institution - 0053
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Local Institution - 0198
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37160
        • Local Institution - 0052
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution - 0051
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0057
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Local Institution - 0056
  • Poland
      • Elblag, Poland, 82-300
        • Local Institution - 0080
      • Torun, Poland, 87-100
        • Local Institution - 0081
      • Wrocław, Poland, 50-088
        • Local Institution - 0112
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Local Institution - 0082
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-665
        • Local Institution - 0177
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Local Institution - 0079
  • Russian Federation
      • Moscow, Russian Federation, 107045
        • Local Institution
      • Novosibirsk, Russian Federation, 630099
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0014
      • Madrid, Spain, 28041
        • Local Institution - 0012
      • Santander, Spain, 39008
        • Local Institution - 0045
      • València, Spain, 46026
        • Local Institution - 0013
  • Taiwan
      • Taichung, Taiwan, 404332
        • Local Institution - 0088
      • Taichung, Taiwan, 407
        • Local Institution - 0089
      • Taichung City, Taiwan, 402
        • Local Institution - 0090
      • Taipei, Taiwan, 10002
        • Local Institution - 0091
      • Taipei, Taiwan, 11217
        • Local Institution - 0087
  • United Kingdom
      • Bradford, United Kingdom, BD5 0NA
        • Local Institution - 0060
      • Hull, United Kingdom, HU3 2JZ
        • Local Institution - 0064
      • Liverpool, United Kingdom, L9 7AL
        • Local Institution - 0077
      • London, United Kingdom, E11 1NR
        • Local Institution - 0062
      • Manchester, United Kingdom, M13 9WL
        • Local Institution - 0105
    • England
      • London, England, United Kingdom, SW17 0QT
        • Local Institution - 0185
  • United States
    • Alabama
      • Mountain Brook, Alabama, United States, 35223
        • Local Institution - 0149
    • California
      • Sacramento, California, United States, 95815
        • Local Institution - 0212
      • Whittier, California, United States, 90602
        • Local Institution - 0188
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Local Institution - 0192
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240
        • Local Institution - 0203
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Local Institution - 0195
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Local Institution - 0169
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Local Institution - 0034
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Local Institution - 0133
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39402
        • Local Institution - 0109
    • New York
      • New York, New York, United States, 10003
        • Local Institution - 0108
      • Rochester, New York, United States, 14642
        • Local Institution - 0186
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Local Institution - 0196
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0180
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Local Institution - 0189
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0147
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Local Institution - 0016
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Local Institution - 0182
    • Texas
      • Lubbock, Texas, United States, 79424
        • Local Institution - 0167
      • Mesquite, Texas, United States, 75150
        • Local Institution - 0070
      • Plano, Texas, United States, 75024
        • Local Institution - 0184
    • Washington
      • Seattle, Washington, United States, 98122
        • Local Institution - 0187
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Local Institution - 0190
      • Milwaukee, Wisconsin, United States, 53217
        • Local Institution - 0175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
  • Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
  • Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
  • Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1
  • Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
  • Must have completed the week 52 treatment for the optional open-label long-term extension period

Exclusion Criteria:

  • Nonplaque psoriasis at Screening or Day 1
  • Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
  • History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
  • Active fibromyalgia
  • Received an approved or investigational biologic therapy for the treatment of PsA or PsO

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Placebo
Specified dose on specified days
Experimental: Deucravacitinib
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Apremilast
Drug: Apremilast
Specified dose on specified days
Other Names:
  • Otezla

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
Time Frame: Week 16
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
Time Frame: Baseline, Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: < 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; >5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Baseline, Week 16
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
Time Frame: Baseline, Week 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
Time Frame: Week 16
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
Time Frame: Baseline, Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Time Frame: Week 16
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Week 16
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Time Frame: Week 16

Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

  1. Tender joint count ≤ 1
  2. Swollen joint count ≤ 1
  3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
  4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
  5. Patient Global Assessment of PsA disease activity ≤ 20
  6. HAQ-DI ≤ 0.5
  7. Tender enthesial points ≤ 1
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
Time Frame: Baseline, Week 16
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Dactylitis Resolution at Week 16
Time Frame: Week 16
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Week 16
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
Time Frame: Week 16
The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
Time Frame: Week 16
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
Time Frame: Week 16
Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline. HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered.
Week 16
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Time Frame: Weeks 4, 8, 12, 16
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Time Frame: Weeks 4, 8, 12, 16
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Time Frame: Weeks 4, 8, 12, 16
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
Time Frame: Baseline, Weeks 4, 12, 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline, Weeks 4, 12, 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Time Frame: Weeks 4, 8, 12, 16
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Weeks 4, 8, 12, 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Time Frame: Weeks 4, 8, 12, 16
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right [R]/left [L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
Weeks 4, 8, 12, 16
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Time Frame: Weeks 4, 8, 12, 16

Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

  1. Tender joint count ≤ 1
  2. Swollen joint count ≤ 1
  3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
  4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
  5. Patient Global Assessment of PsA disease activity ≤ 20
  6. HAQ-DI ≤ 0.5
  7. Tender enthesial points ≤ 1
Weeks 4, 8, 12, 16
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
Time Frame: Baseline, Weeks 4, 12, 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
Baseline, Weeks 4, 12, 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Dactylitis Resolution
Time Frame: Weeks 4, 8, 12, 16
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Weeks 4, 8, 12, 16
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Time Frame: Weeks 2, 4, 8, 12, 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Time Frame: Weeks 2, 4, 8, 12, 16
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Time Frame: Weeks 4, 8, 12, 16
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Weeks 4, 8, 12, 16
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Time Frame: Weeks 2, 4, 8, 12, 16
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Time Frame: Weeks 2, 4, 8, 12, 16
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
Weeks 2, 4, 8, 12, 16
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Time Frame: Baseline, Weeks 4, 12, 16
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 12, 16
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Time Frame: Baseline, Weeks 4, 8, 12, 16
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 8, 12, 16
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Time Frame: Weeks 2, 4, 8, 12, 16
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Time Frame: Weeks 2, 4, 8, 12, 16
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Weeks 2, 4, 8, 12, 16
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Time Frame: Baseline, Week 16
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Week 16
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Time Frame: Baseline, Weeks 4, 16
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 16
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Time Frame: Baseline, Weeks 4, 12, 16
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 12, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-055
  • 2020-005099-36 (EudraCT Number)
  • U1111-1259-9466 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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