Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 8 of 17 for:    lupus | Open Studies | United States, Kansas | United States, Michigan | United States, Minnesota

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02847598
First received: June 6, 2016
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Systemic Lupus Erythematosus (SLE)
Active Cutaneous Lupus Erythematosus (CLE)
Drug: BIIB059
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 290
Actual Study Start Date: October 20, 2016
Estimated Study Completion Date: June 21, 2019
Estimated Primary Completion Date: March 5, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A 50mg
SLE+skin every four weeks (Q4W)
Drug: BIIB059
Anti-BDCA2
Experimental: Part A 150 mg
SLE+skin Q4W
Drug: BIIB059
Anti-BDCA2
Experimental: Part A 450 mg
SLE+skin Q4W
Drug: BIIB059
Anti-BDCA2
Placebo Comparator: Part A Placebo
SLE+skin Q4W
Drug: Placebo
Placebo
Experimental: Part B 450mg
CLE Q4W
Drug: BIIB059
Anti-BDCA2
Placebo Comparator: Part B Placebo
CLE Q4W
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. All women of childbearing potential and all men must practice effective contraception during the study and for 4 months after their last dose of study treatment.
  2. CLASI-A ≥ 8 at Screening and Randomization.

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. Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during Screening, or completion of oral anti-infectives within 2 weeks before or during Screening.
  5. Use of immunosuppressive or disease-modifying treatments for SLE that were initiated less than 3 months prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02847598

Contacts
Contact: Biogen clinicaltrials@biogen.com

  Show 95 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Additional Information:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02847598     History of Changes
Other Study ID Numbers: 230LE201
2015-004359-32 ( EudraCT Number )
Study First Received: June 6, 2016
Last Updated: May 10, 2017

Keywords provided by Biogen:
CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 25, 2017