Phase 2
N=264
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus · Active Cutaneous Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02847598 ↗Enrolled (actual)
264
Serious AEs
7.6%
Results posted
May 2023
Primary outcome: Primary: Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 — -12.7; -9.0; -13.0; -14.5 joints — p=0.037
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIIB059 (litifilimab) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 |
-12.7; -9.0; -13.0; -14.5 | 0.037 sig |
| PRIMARY Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 |
-15.03; -35.52; -47.11; -41.66 | 0.015 sig |
| SECONDARY Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 |
42.11; 50; 16.67; 64.10 | — |
| SECONDARY Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 |
12.12; 38.46; 48.00; 37.50; 21.88; 38.46 | — |
| SECONDARY Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 |
-36.63; -29.32; -8.39; -44.36; -42.55; -41.76 | 0.220 |
| SECONDARY Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 |
-10.73; -38.72; -47.82; -35.25 | 0.001 sig |
| SECONDARY Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 |
57.89; 83.66; 16.67; 71.79 | — |
| SECONDARY Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 |
33.33; 50.00; 76.00; 47.92; 37.50; 46.15 | — |
| SECONDARY Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 |
34.21; 66.67; 16.67; 56.41 | — |
| SECONDARY Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 |
18.18; 38.46; 40.00; 33.33; 21.88; 30.77 | — |
| SECONDARY Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 |
28.57; 33.33; 16.67; 56.25 | — |
| SECONDARY Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 |
-2.1; -3.0; -1.3; -4.4 | 0.007 sig |
| SECONDARY Part A: Percentage of Participants With no New Organ System Affected at Week 24 |
82.14; 100.00; 50.00; 85.94 | — |
| SECONDARY Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 |
-2.46; -2.05; -0.12; -2.45 | 0.667 |
| SECONDARY Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
38; 3; 6; 36; 6; 0 | — |
| SECONDARY Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
22; 18; 15; 38; 3; 1 | — |
| SECONDARY Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants With Positive BIIB059 Antibodies |
1; 0; 0; 5 | — |
| SECONDARY Part B: Number of Participants With Positive BIIB059 Antibodies |
0; 5; 4; 5 | — |
| SECONDARY Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels |
3.350; 3.610; 4.080; 3.116; 0.033; -0.006 | — |
| SECONDARY Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels |
3.341; 3.873; 2.900; 3.061; -0.029; -0.304 | — |
| SECONDARY Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 |
2.017; 3.873; 2.705; 1.495; 0.445; 0.055 | — |
| SECONDARY Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 |
3.538; 0.210; 1.930; 4.193; 0.116; 4.7775 | — |
| SECONDARY Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 |
2.46; 1.73; 2.52; 3.30; -0.07; 0.07 | — |
| SECONDARY Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 |
4.41; 3.00; 5.04; -0.61; 1.20; 0.46 | — |
| SECONDARY Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels |
1.50; -0.53; -1.51; -15.55; -0.10; -0.48 | — |
| SECONDARY Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels |
-1.45; -5.11; -1.32; -1.48; 0.19; -2.98 | — |
| SECONDARY Part A: Percent Change From Baseline in Vaccine Titers at Week 24 |
53.629; 2.996; -10.403; 159.298; -2.263; 17.857 | — |
| SECONDARY Part B: Percent Change From Baseline in Vaccine Titers at Week 12 |
16.835; 4.257; -20.725; 15.437; -3.370; 40.604 | — |
| SECONDARY Part A: Serum Concentration of BIIB059 |
0.0; 0.0; 0.0; 0.7; 2.1; 1.9 | — |
| SECONDARY Part B: Serum Concentration of BIIB059 |
0.0; 0.1; 0.0; 0.4; 1.1; 2.9 | — |
Summary
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) 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).
Eligibility Criteria
Key Inclusion Criteria
Part A:
- 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.
- 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.
- 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:
- 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
- Active lupus nephritis or moderate-to-severe or chronic kidney disease.
- Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT02847598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.