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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02847598
• Date of registration: 06/06/2016
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) LILAC
• Scientific 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
• Date of first enrolment: October 20, 2016
• Target sample size: 264
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02847598
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Bulgaria, Colombia, Israel, Korea, Republic of, Mexico, Philippines, Poland, Serbia, Taiwan, Thailand, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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 (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.

4. 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Active Cutaneous Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: BIIB059

Primary Outcome(s)

Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 [Time Frame: Baseline, Week 16]

Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24 [Time Frame: Baseline, Week 24]

Secondary Outcome(s)

BIIB059 Volume of Distribution [Time Frame: Up to Week 36]

Number of Participants with Clinically Significant Vital Sign Abnormalities [Time Frame: Up to Week 36]

Percentage of Participants with CLASI-50 Response at Week 24 (Part A) and Weeks 12 and 16 (Part B) [Time Frame: Baseline up to Week 24]

Absolute Change From Baseline Over Time in Vaccine Titers [Time Frame: Up to Week 36]

BIIB059 Absorption Rate [Time Frame: Up to Week 36]

Percent Change From Baseline Over Time in Vaccine Titers [Time Frame: Up to Week 36]

Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score to Week 24 (Part A) [Time Frame: Baseline, Week 24]

Change from baseline in Physician's Global Assessment (PGA) visual analog scale (VAS) score (Part A) [Time Frame: Baseline, Week 24]

Percent Change From Baseline Over Time in Immunoglobulin Levels [Time Frame: Up to Week 36]

Absolute Change From Baseline Over Time in Immunoglobulin Levels [Time Frame: Up to Week 36]

BIIB059 Clearance [Time Frame: Up to Week 36]

Percent Change from Baseline in CLASI-A Score to Weeks 12, 16, and 24 (Part A) and Week 12 (Part B) [Time Frame: Baseline up to Week 24]

Percentage of Participants with a Composite Response (Part A) [Time Frame: Baseline, Week 24]

Percentage of Participants with a = 4-point reduction in CLASI-A score Relative to Baseline at Weeks 12 and 16 (Part B), and Week 24 (Part A) [Time Frame: Baseline up to Week 24]

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 36 weeks]

Number of Participants with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities [Time Frame: Up to Week 36]

Number of Participants with Clinically Significant Laboratory Assessment Abnormalities [Time Frame: Up to Week 36]

Number of Participants with Positive Serum BIIB059 Antibodies [Time Frame: Up to Week 36]

Percentage of Participants with no New Organ System Affected (Part A) [Time Frame: Baseline, Week 24]

Secondary ID(s)

230LE201

2015-004359-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors