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Research Trial for Cutaneous Lupus Erythematosus (80 Weeks)


Treatment: Injection Age: 18 Years


Adults 18 years of age or older with a histologically confirmed diagnosis of cutaneous lupus erythematosus (CLE) with or without systemic manifestations, may qualify to participate in this research trial.  Individuals must have a disease activity (CLASI-A) score ≥ 10, representing at least moderate disease severity.

Eligible participants must also have an active CLE lesion despite an adequate trial of antimalarial treatment; one of the following 2 conditions should be met:

a.   antimalarial agents used for at least 12 weeks (either continuous or cumulative) prior to Screening OR

b.   previously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects, and/or lack of therapeutic effect for at least 12 weeks of treatment (and not continuous is acceptable)

Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection.  During the Extension Treatment Period (ETP), all participants will receive active study drug.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last about 80 weeks and involve about 21 visits to the study research site (plus 2 visits which will occur by phone).


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Michael R. Robern

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 23, 2024

Official Title

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in 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 (AMETHYST)

ClinicalTrials.gov ID

NCT05531565

Sponsor

Biogen

Study Description

  • Brief Summary:

    The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] 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 BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

  • Condition or Disease:

    Subacute Cutaneous Lupus Erythematosus

  • Intervention/Treatment:

    Drug: BIIB059 (litifilimab)
    Drug: Placebo
    Drug: BIIB059 (litifilimab)
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Key Inclusion Criteria:

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

Key Exclusion Criteria:

Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
Active severe lupus nephritis.
Active neuropsychiatric SLE.
Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
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 randomization, have not been at a stable and allowable dose.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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