A 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

Phase 1

• Conditions: Subacute Cutaneous Lupus ErythematosusChronic Cutaneous Lupus Erythematosus; MedDRA version: 21.1Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: PTClassification code 10057903Term: Subacute cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: PTClassification code 10057929Term: Chronic cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-000727-40-FR
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-25
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

Key Inclusion Criteria:
1. Histologically confirmed (in the past or at Screening) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 464
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Key Exclusion Criteria:
1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
2. Active severe lupus nephritis.
3. Active neuropsychiatric SLE.
4. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified