Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

October 30, 2020 updated by: Bristol-Myers Squibb

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Local Institution
    • Queensland
      • Wolloongabba, Queensland, Australia, 4102
        • Local Institution
    • Victoria
      • Melbourne, Victoria, Australia, 3053
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Local Institution
      • Edmonton, Alberta, Canada, T5K 1X3
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Local Institution
      • Markham, Ontario, Canada, L3P 1X2
        • Local Institution
      • Mississauga, Ontario, Canada, L5H 1G9
        • Local Institution
      • Peterborough, Ontario, Canada, K9J 5K2
        • Local Institution
      • Toronto, Ontario, Canada, M4W 2N2
        • Local Institution
      • Waterloo, Ontario, Canada, N2J 1C4
        • Local Institution
      • Windsor, Ontario, Canada, N8W 1E6
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3H 1V4
        • Local Institution
  • Germany
      • Dresden, Germany, 01097
        • Local Institution
      • Gera, Germany, 07548
        • Local Institution
      • Hamburg, Germany, 20253
        • Local Institution
      • Hamburg, Germany, 20354
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Kiel, Germany, 24103
        • Local Institution
      • Luebeck, Germany, 23538
        • Local Institution
      • Mahlow, Germany, 15831
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Schwerin, Germany, 19055
        • Local Institution
      • Stuttgart, Germany, 70178
        • Local Institution
  • Japan
      • Kumamoto, Japan, 8608556
        • Local Institution
      • Osaka, Japan, 5500012
        • Local Institution
      • Tokyo, Japan, 1738606
        • Local Institution
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution
    • Fukuoka
      • Fukuoka City, Fukuoka, Japan, 814-0180
        • Local Institution
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0063
        • Local Institution
    • Hyogo
      • Kobe, Hyogo, Japan, 6500017
        • Local Institution
    • Kyoto
      • Kamigyo-ku, Kyoto, Japan, 602-8566
        • Local Institution
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 3290498
        • Local Institution
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8471
        • Local Institution
      • Shinagawa-Ku, Tokyo, Japan, 141-8625
        • Local Institution
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Local Institution
      • Skinjuku-ku, Tokyo, Japan, 1690073
        • Local Institution
  • Latvia
      • Daugavpils, Latvia, LV-5404
        • Local Institution
      • Riga, Latvia, LV-1001
        • Local Institution
      • Riga, Latvia, LV-1003
        • Local Institution
      • Riga, Latvia, LV-1011
        • Local Institution
      • Riga, Latvia, LV-1013
        • Local Institution
      • Ventspils, Latvia, LV3601
        • Local Institution
  • Mexico
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Local Institution
    • Nuevo LEON
      • Monterey, Nuevo LEON, Mexico, 64460
        • Local Institution
  • Poland
      • Krakow, Poland, 31-011
        • Local Institution
      • Lodz, Poland, 90-436
        • Local Institution
      • Lublin, Poland, 20-080
        • Local Institution
      • Osielsko, Poland, 86-031
        • Local Institution
      • Siedlce, Poland, 08 - 110
        • Local Institution
      • Skierniewice, Poland, 96-100
        • Local Institution
      • Warszawa, Poland, 00-660
        • Local Institution
      • Warszawa, Poland, 01-142
        • Local Institution
      • Warszawa, Poland, 01-817
        • Local Institution
      • Warszawa, Poland, 02-758
        • Local Institution
      • Warszawa, Poland, 02-777
        • Local Institution
      • Wroc?aw, Poland, 51-318
        • Local Institution
      • Wroclaw, Poland, 50368
        • Local Institution
  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California Irvine
      • San Diego, California, United States, 92122
        • University of California San Diego
    • Florida
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
    • Georgia
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists, PC
    • Illinois
      • Champaign, Illinois, United States, 61820
        • PMG Research of Christie Clinic, LLC
      • Skokie, Illinois, United States, 60077
        • NorthShore University Health System
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, PLC
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology Clinical Research Center, PLLC
      • Knoxville, Tennessee, United States, 37920
        • Local Institution
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Dermatology Associates

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male and female, ages 18 to 70 years
  • Diagnosis of plaque psoriasis for 6 months
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Blood transfusion within 4 weeks of study drug administration
  • Inability to tolerate oral medication
  • Positive hepatitis-B (HBV) surface antigen
  • Positive hepatitis-C (HCV) antibody
  • Any history or risk for tuberculosis (TB)
  • Any major illness/condition or evidence of an unstable clinical condition
  • Chest X-ray findings suspicious of infection at screening
  • has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
  • Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
  • Has received Rituximab within 6 months of first administration of study medication
  • Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
  • Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication

Other protocol defined inclusion/exclusion criteria could 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986165 Dose 1
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 2
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 3
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 4
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 5
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Placebo Comparator: Placebo
Specified dose of Placebo for BMS-986165 on specified days.
Drug: Placebo for BMS-986165

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Time Frame: Day 1 to Day 85
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Day 1 to Day 85
Number of Participants With Adverse Events
Time Frame: Day 1 to day 115
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
Day 1 to day 115

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Time Frame: Day 1 to Day 85
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Day 1 to Day 85
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Time Frame: Day 1 to Day 85
Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Day 1 to Day 85
Change From Baseline in DLQI Scores on Day 85
Time Frame: Day 1 to Day 85
The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
Day 1 to Day 85
Change From Baseline in BSA on Day 85
Time Frame: Day 1 to Day 85
Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
Day 1 to Day 85
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Time Frame: Days 8, 15, 29, 57, 85
Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Days 8, 15, 29, 57, 85

Collaborators and Investigators

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

Sponsor

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.

General Publications

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)

November 15, 2016

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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