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

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ClinicalTrials.gov Identifier: NCT02847598
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE October 20, 2016
Actual Primary Completion Date August 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24 [ Time Frame: Baseline, Week 24 ]
    An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
  • 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 ]
    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 scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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 ]
    CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24 (Part A) and Weeks 12 and 16 (Part B). 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 scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
  • 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 ]
    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 scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
  • 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 ]
    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 scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
  • Percentage of Participants with a Composite Response (Part A) [ Time Frame: Baseline, Week 24 ]
    Composite response is defined as: Participants with a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) of ≥4 (SRI-4) at Week 24. SRI-4 is defined as a reduction from baseline of ≥4 points in SLE Disease Activity Index 2000 (SLEDAI-2K). Participants will also have no new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. No worsening from baseline in the participant's lupus disease activity is to be present, defined by <0.3 point increase in Physician's Global Assessment (PGA) visual analogue scale (VAS). Lastly, the participants will have no protocol-prohibited medication or treatment, concomitant corticosteroid dosage at Week 24 is <=10 mg/day, concomitant corticosteroid dosage at Week 24 is <=Day 1 corticosteroid dosage, and there is to be no increase in corticosteroid dose between Weeks 17 and 24.
  • Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score to Week 24 (Part A) [ Time Frame: Baseline, Week 24 ]
    The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
  • Percentage of Participants with no New Organ System Affected (Part A) [ Time Frame: Baseline, Week 24 ]
    No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B.
  • Change from baseline in Physician's Global Assessment (PGA) visual analog scale (VAS) score (Part A) [ Time Frame: Baseline, Week 24 ]
  • BIIB059 Clearance [ Time Frame: Up to Week 36 ]
  • BIIB059 Volume of Distribution [ Time Frame: Up to Week 36 ]
  • BIIB059 Absorption Rate [ Time Frame: Up to Week 36 ]
  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 36 weeks ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
  • Number of Participants with Clinically Significant Laboratory Assessment Abnormalities [ Time Frame: Up to Week 36 ]
  • Number of Participants with Clinically Significant Vital Sign Abnormalities [ Time Frame: Up to Week 36 ]
  • Number of Participants with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities [ Time Frame: Up to Week 36 ]
  • Number of Participants with Positive Serum BIIB059 Antibodies [ Time Frame: Up to Week 36 ]
  • Absolute Change From Baseline Over Time in Immunoglobulin Levels [ Time Frame: Up to Week 36 ]
  • Absolute Change From Baseline Over Time in Vaccine Titers [ Time Frame: Up to Week 36 ]
  • Percent Change From Baseline Over Time in Immunoglobulin Levels [ Time Frame: Up to Week 36 ]
  • Percent Change From Baseline Over Time in Vaccine Titers [ Time Frame: Up to Week 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Active Cutaneous Lupus Erythematosus
Intervention  ICMJE
  • Drug: BIIB059
    Administered as specified in the treatment arm.
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • Experimental: Part A: BIIB059 450 mg
    BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with systemic lupus erythematosus [SLE] with active skin manifestations and joint involvement.
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part A: Placebo
    BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with [SLE] with active skin manifestations and joint involvement.
    Intervention: Drug: Placebo
  • Experimental: Part B: BIIB059 50 mg
    BIIB059 50 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active cutaneous lupus erythematosus [CLE] with or without systemic manifestations.
    Intervention: Drug: BIIB059
  • Experimental: Part B: BIIB059 150 mg
    BIIB059 150 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.
    Intervention: Drug: BIIB059
  • Experimental: Part B: BIIB059 450 mg
    BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part B: Placebo
    BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
264
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
290
Actual Study Completion Date  ICMJE November 18, 2019
Actual Primary Completion Date August 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Colombia,   Israel,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Serbia,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02847598
Other Study ID Numbers  ICMJE 230LE201
2015-004359-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP