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Active, not recruitingNCT05531565AMETHYSTUpdated Oct 1, 2026

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

A Phase 2/3 interventional study of Litifilimab and Placebo in Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, sponsored by Biogen. Active, not recruiting at 315 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Biogen · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) 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 main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs 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).

The main questions researchers want to answer are:

  • How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
  • How many participants have their skin disease activity go down by at least 70% as measured by CLASI?

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.

The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:

  • After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
  • Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
  • The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
  • This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
  • During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
  • After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
  • The total study duration for participants will be up to 80 weeks.
Read the detailed description

Litifilimab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2. It is an inhibitory receptor expressed on the surface of human plasmacytoid dendritic cell (pDCs) and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the CLA-IGA-R score [Parts A] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab [Parts A and B].

02

Conditions studied

  • Subacute Cutaneous Lupus Erythematosus
  • Chronic Cutaneous Lupus Erythematosus

Keywords

  • Cutaneous Lupus Erythematosus (CLE)
  • Discoid Lupus Erythematosus (DLE)
  • Systemic Lupus Erythematosus (SLE)
  • Lupus
  • Subacute Cutaneous Lupus Erythematosus (SCLE)
03

In context

Lupus Erythematosus, Cutaneous

66 studies on the registry are indexed under Lupus Erythematosus, Cutaneous; 17 are open to participants now.

This study's planned enrollment of 450 is above the median of 31 across 56 interventional studies indexed under Lupus Erythematosus, Cutaneous.

Browse Lupus Erythematosus, Cutaneous studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
  2. Must have active cutaneous manifestations that meet study criteria.
  3. Must have a CLASI-A score ≥10.
  4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

  1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
  3. Active severe lupus nephritis.
  4. Active neuropsychiatric SLE.
  5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
  6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to screening, have not been at a stable and allowable dose.

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

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    Part A (Phase 2): Litifilimab

    Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

    Drug: Litifilimab

  • Placebo comparator
    Part A (Phase 2): Placebo

    Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.

    Drug: Placebo

  • Experimental
    Part B (Phase 3): Litifilimab

    Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

    Drug: Litifilimab

  • Placebo comparator
    Part B (Phase 3): Placebo

    Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.

    Drug: Placebo

Interventions

  • DrugLitifilimab

    Administered as specified in the treatment arm.

    Also known as: BIIB059

  • DrugPlacebo

    Administered as specified in the treatment arm.

06

What researchers measure

Primary outcomes

  1. Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

    Time frame: Week 16

  2. Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP)

    Time frame: Week 52

  2. Part A: Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  3. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 &24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP

    Time frame: Week 52

  4. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During DBPC TP

    Time frame: Week 52

  5. Part A: Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP

    Time frame: Week 52

  6. Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Time frame: Week 52

  7. Part A: Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Time frame: Week 52

  8. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP

    Time frame: Week 52

  9. Part A: Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Time frame: Week 52

  10. Part A: Percentage of Participants who Have CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP

    Time frame: Week 52

  11. Part A: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16

    Time frame: Up to Week 16

  12. Part A: Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52

    Time frame: Baseline to Week 52

  13. Part A: Percent Change in CLASI-D Score

    Time frame: Baseline to Week 52

  14. Part B: Percentage of Participants who Achieve a CLASI A score of 0 to 3

    Time frame: Week 24

  15. Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 2-Point Improvement From Baseline at Week 24, for Participants who had CLA-IGA-R OMC Score ≥ 2 at Baseline

    Time frame: Week 24

  16. Part B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and Other OMC Score ≥3 at Baseline

    Time frame: Weeks 16 and 24

  17. Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline

    Time frame: Weeks 16 and 24

  18. Part B: Percentage of Participants who Achieve CLA IGA R Erythema Score of 0 or 1

    Time frame: Up to Week 24

  19. Part B: Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score

    Time frame: Up to Week 24

  20. Part B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 5

    Time frame: Up to Week 24

  21. Part B: Percentage of Participants who Achieve a CLASI-50a Response, Defined as a ≥ 50% Decrease in Baseline CLASI-A Score in Addition to Achieving Mild Disease Severity With a CLASI-A Score <10 at Week 16 and Week 24, Respectively

    Time frame: Weeks 16 and 24

  22. Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  23. Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  24. Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  25. Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  26. Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Responders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  27. Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  28. Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  29. Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  30. Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  31. Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  32. Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Nonresponders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  33. Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Time frame: Week 52

  34. Part B: Absolute Change in CLASI-D Score

    Time frame: Week 52

  35. Part B: Percent Change in CLASI-D Score

    Time frame: Week 52

  36. Part B: Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score

    Time frame: Part B: Weeks 16, 24 and 52

  37. Part B: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

    Time frame: Part B: Weeks 16, 24 and 52

  38. Part B: Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash

    Time frame: Part B: Weeks 16, 24 and 52

  39. Part B: Change From Baseline in NRS for Itch in Skin Rash

    Time frame: Part B: Weeks 16, 24 and 52

  40. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1

    Time frame: Part A: Week 24; Part B: Weeks 16 and 24

  41. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline

    Time frame: Part A: Weeks 16 and 24; Part B: Up to Week 24

  42. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0

    Time frame: Part A: Weeks 16 and 24; Part B: Up to Week 24

  43. Parts A and B: Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score

    Time frame: Part A: Weeks 16 and 24; Part B: Up to Week 24

  44. Parts A and B: Percentage of Participants who Have a CLA-IGA-R Follicular Activity Score of 0

    Time frame: Part A: Weeks 16 and 24; Part B: Up to Week 24

  45. Parts A and B: Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline

    Time frame: Parts A: Weeks 16 and 24; Part B: Week 12

  46. Parts A and B: Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline

    Time frame: Part A: Weeks 16 and 24; Part B: Weeks 12 and 24

  47. Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 or 1

    Time frame: Up to Week 24

  48. Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 3

    Time frame: Up to Week 24

  49. Parts A and B: Percentage of Participants who Achieve a CLASI 70 Response

    Time frame: Up to Week 24

  50. Parts A and B: Percentage of Participants who Achieve a CLASI 50 Response

    Time frame: Up to Week 24

  51. Parts A and B: Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score

    Time frame: Up to Week 24

  52. Parts A and B: Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index Rate and Annualized Severe SFI Rate Through Week 24

    Time frame: Up to Week 24

  53. Parts A and B: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52

    Time frame: Up to Week 52

  54. Parts A and B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 76

  55. Parts A and B: Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study

    Time frame: Up to Week 76

07

Study locations

315 sites
  • Pinnacle Research Group, LLC
    Anniston, Alabama 36207, United States
  • UAB Center for Women's Reproductive Health
    Birmingham, Alabama 35233-7340, United States
  • Arizona Arthritis & Rheumatology Research, PLLC
    Phoenix, Arizona 85032, United States
  • The Regents of the University of California
    La Jolla, California 92037, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • Clinical Science Institute
    Santa Monica, California 90404, United States
  • Inland Rheumatology Clinical Trials, Inc.
    Upland, California 91786, United States
  • Denver Arthritis Clinic
    Denver, Colorado 80230, United States
  • Omega Research Debary, LLC
    DeBary, Florida 32713, United States
  • Centre for Rheumatology, Immunology and Arthritis
    Fort Lauderdale, Florida 33334, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • University of Miami Miller School of Medicine
    Miami, Florida 33125, United States
  • Millennium Medical Research, LLC
    Miami, Florida 33126, United States
  • Medical Research Center of Miami
    Miami, Florida 33134, United States
  • Diverse Clinical Research LLC
    Miami, Florida 33175, United States
  • Charisma Medical and Research Center
    Miami Lakes, Florida 33014, United States
  • Leading Edge Dermatology
    Plantation, Florida 33317, United States
  • Augusta University
    Augusta, Georgia 30912, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • OrthoIllinois
    Rockford, Illinois 61114, United States
  • Dawes Fretzin Clinical Research Group, LLC
    Indianapolis, Indiana 46250, United States
  • Equity Medical
    Bowling Green, Kentucky 42104, United States
  • LSU Health Sciences Center Shreveport
    New Orleans, Louisiana 70112, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Brigham And Women's Hospital
    Boston, Massachusetts 02115, United States
  • Essential Dermatology
    Natick, Massachusetts 01760, United States
  • Beacon Clinical Research, LLC
    Quincy, Massachusetts 02169, United States
  • University of Massachusetts, Worcester
    Worcester, Massachusetts 01655, United States
  • David Fivenson, MD, Dermatology, PLLC
    Ann Arbor, Michigan 48103, United States
  • Oakland Hills Dermatology
    Auburn Hills, Michigan 48326, United States
  • AA MRC LLC Ahmed Arif Medical Research Center
    Flint, Michigan 48504, United States
  • Revival Research Institute, LLC
    Troy, Michigan 48084, United States
  • Saint Louis University
    St Louis, Missouri 63110, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Albuquerque Center For Rheumatology
    Albuquerque, New Mexico 87102, United States
  • University of New Mexico School of Medicine
    Albuquerque, New Mexico 87106, United States
  • NYU Langone Brooklyn
    Brooklyn, New York 11220, United States
  • Universal Dermatology, PLLC
    Fairport, New York 14450, United States
  • Northwell Health, Inc. PRIME
    Great Neck, New York 11021, United States
  • Columbia University Medical center
    New York, New York 10032, United States
  • Hawthorne Health
    Staten Island, New York 10309, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • Duke Dermatology South Durham
    Durham, North Carolina 27710, United States
  • Medication Management, LLC
    Greensboro, North Carolina 27405, United States
  • University of Cincinnati Department of Dermatology
    Cincinnati, Ohio 45219, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Penn State University Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Austin Regional Clinic, P.A.
    Austin, Texas 78731, United States
  • Precision Comprehensive Clinical Research Solutions
    Colleyville, Texas 76034, United States
  • Metroplex Clinical Research Center, LLC
    Dallas, Texas 75231, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390-8896, United States
  • North Texas Center for Clinical Research
    Frisco, Texas 75034, United States
  • UTMB Department of Dermatology
    Galveston, Texas 77555-0583, United States
  • University of Texas Health Science Center at Houston
    Houston, Texas 77054, United States
  • Arthritis & Osteoporosis Clinic
    Waco, Texas 76710, United States
  • Velocity Clinical Research Waco
    Waco, Texas 76710, United States
  • University of Utah Health Sciences Center
    Salt Lake City, Utah 84132, United States
  • Open Door Clinical Research
    Blacksburg, Virginia 24060, United States
  • West End Dermatology Associates
    Richmond, Virginia 23233, United States
  • CINME - Centro De Investigaciones Metabolicas
    CABA, Buenos Aires C1056ABI, Argentina
  • Centro de Investigaciones Medicas Mar del Plata
    Mar del Plata, Buenos Aires 7600, Argentina
  • Instituto de Investigaciones Clinicas Quilmes
    Quilmes, Buenos Aires B1878GEG, Argentina
  • Centro de Investigaciones San Miguel
    San Miguel, Buenos Aires 1663, Argentina
  • APRILLUS Asistencia e Investigacion
    Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA, Argentina
  • Fundacion Respirar
    Buenos Aires, Ciudad Autonoma Buenos Aires C1426ABO, Argentina
  • Consultorio Alto Dorrego
    Villa Nueva, Mendoza Province CP 5519, Argentina
  • Instituto CAICI
    Rosario, Santa Fe Province S2000PBJ, Argentina
  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
    San Miguel de Tucumán, Tucumán Province 4000, Argentina
  • Centro de Investigaciones Medicas Tucuman
    San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
  • Investigaciones Clinicas Tucuman
    San Miguel de Tucumán, Tucumán Province T4000ICL, Argentina
  • Hospital Italiano de La Plata
    Buenos Aires, B1900AXI, Argentina
  • Hospital Italiano de Buenos Aires
    Ciudad Autonoma Buenos Aires, C1199ABB, Argentina
  • Centro Privado de Medicina Familiar - Mind Out Research
    Ciudad Autonoma Buenos Aires, C1417, Argentina
  • Clinica Adventista Belgrano
    Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
  • Instituto de Reumatologia
    Mendoza, M5500, Argentina
  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
    San Juan, 5400, Argentina
  • UZ Leuven
    Leuven, Vlaams-Brabant 03000, Belgium
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
  • Universitair Ziekenhuis Gent
    Ghent, 9000, Belgium
  • Centre Hospitalier Universitaire de Liege
    Liège, 4000, Belgium
  • Integrare Terapêutica
    Fortaleza, Ceará 60125-000, Brazil
  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
    Fortaleza, Ceará 60430-370, Brazil
  • CEDOES - Diagnóstico e Pesquisa
    Vitória, Espírito Santo 29055-450, Brazil
  • Clínica SER da Bahia
    Salvador, Estado de Bahia 40150-150, Brazil
  • L2IP - Instituto de Pesquisas Clínicas Ltda.
    Brasília, Federal District 70200-730, Brazil
  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    Santo Ângelo, Mato Grosso 78020-500, Brazil
  • Santa Casa de Misericordia de Belo Horizonte
    Belo Horizonte, Minas Gerais 30150-221, Brazil
  • Freire Pesquisa Clinica
    Belo Horizonte, Minas Gerais 30150-320, Brazil
  • Clinica Pulsus
    Belo Horizonte, Minas Gerais 30180-065, Brazil
  • CMiP - Centro Mineiro de Pesquisa
    Juiz de Fora, Minas Gerais 36010-570, Brazil
  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
    Rio de Janeiro, Rio Do Janeiro 20241-180, Brazil
  • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
    Rio de Janeiro, Rio Do Janeiro 22470-220, Brazil
  • Hospital Bruno Born
    Lajeado, Rio Grande do Sul 95900-000, Brazil
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
  • Nucleo de Pesquisa Clinica do Rio Grande do Sul
    Porto Alegre, Rio Grande do Sul 90430001, Brazil
  • LMK Serviços Médicos S/S Ltda
    Porto Alegre, Rio Grande do Sul 90480-000, Brazil
  • Hospital Moinhos de Vento
    Porto Alegre, Rio Grande do Sul 90560032, Brazil

Showing the first 100 of 315 sites across 30 countries.

08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531565
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Sep 13, 2022
Primary completion
Oct 20, 2026 (estimated)
Completion
Dec 14, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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