Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04961567 | A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 562 | — | — | Jul 16, 2021 | Mar 16, 2027 | Jan 29, 2026 | 177 | United States, Argentina +15 |
| NCT04895241 | A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 548 | — | — | May 25, 2021 | Mar 16, 2027 | Feb 10, 2026 | 164 | United States, Australia +13 |
An SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). * No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS). * No violation to protocol-specified medication rules.
| Arm | Type | Description |
|---|---|---|
| Litifilimab High Dose | EXPERIMENTAL | Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2. |
| Litifilimab Low Dose | EXPERIMENTAL | Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2. |
| Placebo | PLACEBO_COMPARATOR | Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2. |
| Name | Type | Description |
|---|---|---|
| Litifilimab | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician. * Participant has a ...