Clinical Trial: Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Su

Brief Summary: The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing skin disease activity in participants with systemic lupus erythematosus (SLE) (Part A), and in participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations (Part B), and to investigate the dose response relationship in participants with active SLE and skin manifestations (Part A only). Secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE disease activity.

Detailed Summary:
Sponsor: Biogen

Current Primary Outcome: Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score [ Time Frame: Week 12 ]

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity score is based on the degree of erythema, scale, mucous membrane lesions, and nonscarring alopecia.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • CLASI-50 response [ Time Frame: Up to Week 24 ]
    Defined as a 50% improvement from baseline in CLASI-A score.
  • Percent change from baseline over time in CLASI-A score [ Time Frame: Up to Week 24 ]
  • A ≥ 4-point reduction in CLASI-A score [ Time Frame: Up to Week 24 ]
  • Composite of Systemic Lupus Erythematosus Responder Index response of ≥ 4 (SRI-4) at Week 24 [ Time Frame: Week 24 ]
  • Change from baseline to Week 24 in Physician's Global Assessment (PGA) visual analog scale (VAS) score [ Time Frame: Week 24 ]
  • Change from baseline to Week 24 in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score [ Time Frame: Week 24 ]
  • No new British Isles Lupus Activity Group (BILAG)-2004 A or ≤ 2B to Week 24 [ Time Frame: Week 24 ]
  • Number of participants experiencing Adverse Events (AEs and Serious Adverse Events (SAEs) [ Time Frame: Up to 36 weeks ]
  • BIIB059 clearance [ Time Frame: Up to 36 weeks ]
  • BIIB059 volume of distribution [ Time Frame: Up to 36 weeks ]
  • BIIB059 absorption rate [ Time Frame: Up to 36 weeks ]
  • Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to 36 weeks ]
  • Number of participants with clinically significant Vital sign abnormalities [ Time Frame: Up to 36 weeks ]
  • Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to 36 weeks ]
  • Number of participants with positive serum BIIB059 antibodies [ Time Frame: Up to 36 weeks ]
  • Absolute change from baseline over time in immunoglobulin levels [ Time Frame: Up to 36 weeks ]
  • Absolute change from baseline over time in vaccine titers [ Time Frame: Up to 36 weeks ]
  • Percent change from baseline over time in immunoglobulin levels [ Time Frame: Up to 36 weeks ]
  • Percent change from baseline over time in vaccine titers [ Time Frame: Up to 36 weeks ]


Original Secondary Outcome: Same as current

Information By: Biogen

Dates:
Date Received: June 6, 2016
Date Started: October 20, 2016
Date Completion: June 21, 2019
Last Updated: May 10, 2017
Last Verified: May 2017