A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (AMETHYST LTE)

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.

The main objective of the study is to learn more about the long-term safety of litifilimab.

The main question researchers want to answer is:

• How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.

The study will be done as follows:

• The last visit of parent study 230LE301 will be the first visit of study 230LE305.
• All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
• Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.

Study Overview

• Status: Enrolling by invitation
• Conditions: Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: BIIB059 (litifilimab)

Detailed Description

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with SLE; to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1406AGA
    • APRILLUS Asistencia e Investigacion
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000PBJ
      • Instituto CAICI
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Centro de Investigaciones Medicas Tucuman
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Investigaciones Clinicas Tucuman
• Brazil
  • Rio de Janeiro, Brazil, 22470-220
    • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • Clínica SER da Bahia
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • L2IP - Instituto de Pesquisas Clínicas Ltda.
  • Mato Grosso
    • Santo Ângelo, Mato Grosso, Brazil, 78020-500
      • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • CMiP - Centro Mineiro de Pesquisa
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Nucleo de Pesquisa Clínica do Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
      • LMK Serviços Médicos S/S Ltda
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04266-010
      • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
• Bulgaria
  • Sofia, Bulgaria, 1431
    • DCC 'Alexandrovska', EOOD
  • Sofia, Bulgaria, 1463
    • DCC Focus 5 - MEOH OOD
  • Sofia City Province
    • Sofia, Sofia City Province, Bulgaria, 1612
      • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2W 4X9
      • Laser Rejuvenation Clinics, Inc.
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • DIEX Recherche Sherbrooke Inc.
• Chile
  • Las Condes, Chile, 7580206
    • Centro Medico SkinMed
  • Santiago, Chile, 8420383
    • CIEC - Centro Internacional de Estudios Clínicos
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital, Capital Medical University
  • Guangdong
    • Shenzhen, Guangdong, China, 518029
      • Shenzhen Second People's Hospital
  • Guangdongsheng
    • Dongguan, Guangdongsheng, China, 523059
      • Dongguan People's Hospital
    • Guangzhou, Guangdongsheng, China, 510515
      • Nanfang Hospital of Southern Medical University
  • Húnánsheng
    • Changsha, Húnánsheng, China, 410011
      • The second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Hospital for Skin Diseases, Chinese Academy of Medical Sciences
  • Shànghaishì
    • Shanghai, Shànghaishì, China, 200443
      • Shanghai Skin Disease Hospital
  • Yun'Nan
    • Kunming, Yun'Nan, China, 650101
      • The Second Affiliated Hospital of Kunming Medical University
• Colombia
  • Barranquilla, Colombia, 80020
    • Centro de Investigacion Medico Asistencial S.A.S
  • Cundinamarca
    • Zipaquirá, Cundinamarca, Colombia, 250252
      • Healthy Medical Center
• France
  • Paris, France, 75020
    • Hôpital Tenon
  • Calvados
    • Caen, Calvados, France, 14033
      • CHU de Caen - Hopital de la Cote de Nacre
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • Hopital Larrey
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Saint Eloi
  • Rhone
    • Lyon, Rhone, France, 69003
      • Hopital Edouard Herriot - CHU Lyon
• Germany
  • Berlin, Germany, 10117
    • Charité - Campus Charité Mitte
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim Dermatologie
    • Oldenburg, Lower Saxony, Germany, 26133
      • Klinikum Oldenburg AoeR
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitaetsklinikum Muenster
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus TU
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Universitaetsklinikum Halle (Saale)
• Hungary
  • Pécs, Hungary, 07632
    • Pecsi Tudomanyegyetem Klinikai Kozpont
• Italy
  • Florence, Italy, 50121
    • Università degli studi di Firenze
  • Milan, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 457-8510
      • JCHO Chukyo Hospital
    • Nagoya, Aichi-ken, Japan, 460-0001
      • NHO Nagoya Medical Center
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • University of Fukui Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health
  • Hyōgo
    • Kakogawa-shi, Hyōgo, Japan, 675-8611
      • Kakogawa Central City Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-8556
      • Kumamoto University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Nagasaki
    • Nagasaki, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital
  • Osaka
    • Osaka, Osaka, Japan, 543-8922
      • Osaka Keisatsu Hospital
  • Tokyo-To
    • Itabashi-ku, Tokyo-To, Japan, 173-8606
      • Teikyo University Hospital
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua, S.C.
  • Guadalajara, Mexico, 44950
    • Centro de investigacion medica y reumatologia
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Clinstile, S.A. de C.V.
• Philippines
  • Manila, Philippines, 1000
    • University of the Philippines Manila - Philippine General Hospital
  • Manila, Philippines, 1012
    • Jose R. Reyes Memorial Medical Center
  • Batangas
    • Lipa City, Batangas, Philippines, 4127
      • Mary Mediatrix Medical Center
  • La Union
    • San Fernando City, La Union, La Union, Philippines, 2500
      • Lorma Medical Center
  • National Capital Region (ncr)
    • Quezon City, National Capital Region (ncr), Philippines, 1102
      • St. Luke's Medical Center
• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Royalderm_Warszawa
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
• Portugal
  • Coimbra District
    • Coimbra, Coimbra District, Portugal, 3000-075
      • Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology_Belgrade
• Slovakia
  • Košice, Slovakia, 04011
    • Artromac n.o.
• South Korea
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
• Spain
  • Barcelona, Spain, 8041
    • Hospital de La Santa Creu I Sant Pau
  • Barcelona, Spain, 8003
    • Hospital del Mar
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Cantabria
    • Valladolid, Cantabria, Spain, 47012
      • Hospital Universitario Rio Hortega
  • Córdoba
    • Córdoba, Córdoba, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Sweden
  • Solna, Sweden, 17000
    • Karolinska Universitetssjukhuset - Solna
• Switzerland
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • Lucerne (Luzern)
    • Lausanne, Lucerne (Luzern), Switzerland, CH-1011
      • Centre Hospitalier Universitaire Vaudois (CHUV)
• Taiwan
  • Taichung, Taiwan, 407219
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2GW
      • Queen Elizabeth Hospital
  • West Yorkshire
    • Chapel Allerton, West Yorkshire, United Kingdom, LS7 4SA
      • Chapel Allerton Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - (UAB)
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, Dermatology, PLLC
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Saint Louis University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7280
      • Thurston Arthritis Research Center
    • Durham, North Carolina, United States, 27710
      • Duke Dermatology South Durham
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Health Physicians Office Dermatology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75390-8896
      • UT Southwestern Medical Center
    • Grapevine, Texas, United States, 76034
      • Precision Comprehensive Clinical Research Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
• Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.

Key Exclusion Criteria:

• Early Part A or Part B parent study (230LE301 [NCT05531565]) treatment terminators (participants who discontinued study treatment before Week 48).
• Early Part A or Part B parent study terminators [participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)].
• Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB059; Participants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 204 in the LTE period.	Drug: BIIB059 (litifilimab); Administered as specified in the treatment arm.; Other Names: litifilimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 232 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])	Up to 232 weeks
Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])	Up to 232 weeks
Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])	Up to 232 weeks
Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1	Up to 232 weeks
Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0	Up to 232 weeks
Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at LTE Baseline	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study)	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE Baseline	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline	Day 1 (LTE Baseline) up to 232 weeks
Percentage of Participants who Achieve a CLASI A Score of 0 to 3	Up to 232 weeks
Percentage of Participants who Achieve a CLASI-A Score of 0 to 5	Up to 232 weeks
Percentage of Participants With a CLASI-A 0 to 3 Response Among CLASI-A 0 to 3 Responders at LTE Baseline	Day 1 (LTE Baseline) up to 232 weeks
Absolute Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208	Day 1 (Baseline of Parent study) up to 208 weeks
Percent Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208	Day 1 (Baseline of Parent study) up to 208 weeks
Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 208	Up to 208 weeks
Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 208	Up to 208 weeks
Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates	Up to 208 weeks
Percentage of Participants With Oral Corticosteroid (OCS) Dose Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)	Day 1 (Baseline of Parent study) up to 208 weeks
Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day) Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)	Day 1 (Baseline of Parent study) up to 208 weeks
Percentage of Participants With OCS ≤ 5.0 mg/day Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)	Day 1 (Baseline of Parent study) up to 208 weeks
Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Week 208	Baseline, Week 208
Change From Baseline Value (Parent Study [NCT05531565]) in European Quality of Life - 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Week 104	Baseline, Week 104
Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Week 104	Baseline, Week 104
Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Week 104	Baseline, Week 104
Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Week 104	Baseline, Week 104
Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Week 208	Baseline, Week 208
Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Week 208	Baseline, Week 208
Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Week 208	Baseline, Week 208
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters	Up to 208 weeks
Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results	Up to 232 weeks
Number of Participants With Anti-BIIB059 Antibodies in Serum	Up to 232 weeks
Serum Concentration of Litifilimab	Pre-dose up to 232 weeks
Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline	Day 1 (LTE Baseline) up to 232 weeks

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): June 26, 2029
• Study Completion (Estimated): December 11, 2029

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Other Study ID Numbers: 230LE305; 2023-504863-17 (Other Identifier: EU CTIS Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No