Summary

for people ages 18-75 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

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 Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

Keywords

Systemic Lupus Erythematosus Active Cutaneous Lupus Erythematosus CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Lupus Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous BIIB059

Eligibility

For people ages 18-75

Key Inclusion Criteria:

Part A:

  1. Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
  2. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
  3. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.

Part B:

  1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.

Key Exclusion Criteria:

  1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.
  2. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
  3. History of chronic, recurrent, or recent serious infection.
  4. History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
  5. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Universtiy of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Robin K. Dore, MD, Inc. in progress, not accepting new patients
    Tustin California 92780 United States
  • Tien Q Nguyen MD Inc accepting new patients
    Fountain Valley California 92708 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
ID
NCT02847598
Phase
Phase 2
Study Type
Interventional
Last Updated