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Also known as BIIB059 (litifilimab), BIIB059
Litifilimab · 7 trials · 7 indications
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.
An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.
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.
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
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. Higher scores indicate more disease activity.
| Arm | Type | Description |
|---|---|---|
| BIIB059 | EXPERIMENTAL | Participants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 204 in the LTE period. |
| Litifilimab Low Dose | EXPERIMENTAL | Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2. |
| Litifilimab High Dose | EXPERIMENTAL | Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks 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. |
| Part A (Phase 2): Litifilimab | EXPERIMENTAL | Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26. |
| Part A (Phase 2): Placebo | PLACEBO_COMPARATOR | Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26. |
| Part B (Phase 3): Litifilimab | EXPERIMENTAL | Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26. |
| Part B (Phase 3): Placebo | PLACEBO_COMPARATOR | Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26. |
| Part A: BIIB059 450 mg | EXPERIMENTAL | BIIB059 450 mg administered SC, 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. |
| Part A: Placebo | PLACEBO_COMPARATOR | BIIB059 matching placebo administered SC, Q4W with an additional dose at Week 2 for total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with SLE with active skin manifestations and joint involvement. |
| Part B: BIIB059 50 mg | EXPERIMENTAL | BIIB059 50 mg administered SC, 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. |
| Part B: BIIB059 150 mg | EXPERIMENTAL | BIIB059 150 mg administered SC, 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. |
| Part B: BIIB059 450 mg | EXPERIMENTAL | BIIB059 450 mg administered, 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. |
| Part B: Placebo | PLACEBO_COMPARATOR | BIIB059 matching placebo administered SC, 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. |
| Part 1, Cohort 1: BIIB059 0.05 mg/kg IV | EXPERIMENTAL | BIIB059 0.05 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 2: BIIB059 0.3 mg/kg IV | EXPERIMENTAL | BIIB059 0.3 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 3: BIIB059 1 mg/kg IV | EXPERIMENTAL | BIIB059 1 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 4: BIIB059 3 mg/kg IV | EXPERIMENTAL | BIIB059 3 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 5: BIIB059 10 mg/kg IV | EXPERIMENTAL | BIIB059 10 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 6: BIIB059 20 mg/kg IV | EXPERIMENTAL | BIIB059 20 mg/kg IV dose, Once on Day 1 |
| Part 1, Cohort 7: BIIB059 50 mg SC | EXPERIMENTAL | BIIB059 50 mg SC dose, Once on Day 1 |
| Part 1, Cohort 1-6: Placebo IV | PLACEBO_COMPARATOR | Matching placebo IV dose, Once on Day 1 |
| Part 1, Cohort 7: Placebo SC | PLACEBO_COMPARATOR | Matching placebo SC dose, Once on Day 1 |
| Part 2, Cohort 8: BIIB059 20 mg/kg IV | EXPERIMENTAL | BIIB059 20 mg/kg IV dose, Once on Day 1 |
| Part 2, Cohort 8: Placebo IV | PLACEBO_COMPARATOR | Matching placebo IV dose, Once on Day 1 |
| Part 3a, Cohort 9: BIIB059 20 mg SC | EXPERIMENTAL | BIIB059 20 mg SC dose, Every 4 weeks for 2 doses |
| Part 3a, Cohort 10: BIIB059 50 mg SC | EXPERIMENTAL | BIIB059 50 mg SC dose, Every 4 weeks for 2 doses |
| Part 3a, Cohort 11: BIIB059 150 mg SC | EXPERIMENTAL | BIIB059 150 mg SC dose, Every 4 weeks for 2 doses |
| Part 3a, Cohort 12: BIIB059 300 mg or less SC | EXPERIMENTAL | BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses |
| Part 3a, Cohort 9-12: Placebo SC | PLACEBO_COMPARATOR | Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses |
| Part 3b, Cohort 13: BIIB059 50 mg SC | EXPERIMENTAL | BIIB059 50 mg SC dose, Every 4 weeks for 2 doses |
| Part 3b, Cohort 14: BIIB059 300 mg or less SC | EXPERIMENTAL | BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses |
| Part 3b, Cohort 13-14: Placebo SC | PLACEBO_COMPARATOR | Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses |
| Name | Type | Description |
|---|---|---|
| BIIB059 (litifilimab) | DRUG | Administered as specified in the treatment arm. |
| Litifilimab | DRUG | Administered as specified in the treatment arm. |
| Litifilimab-matching placebo | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52). * Ability of the participant to understand the purpose and risks of the...
Litifilimab is an investigational monoclonal antibody being studied for subacute cutaneous lupus erythematosus and systemic lupus erythematosus. It is designed to reduce disease symptoms in adults with these autoimmune conditions. It has not been approved for any indication and remains in clinical development.
Litifilimab targets CLEC4C, also known as blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells. By inhibiting CLEC4C, the antibody aims to reduce type I interferon production, a key driver of inflammation in lupus. This targeted approach is intended to modulate the immune response underlying cutaneous and systemic lupus erythematosus.
Litifilimab is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sole sponsor of the clinical program, including the Phase 3 trials for cutaneous and systemic lupus erythematosus.
Litifilimab is in Phase 3 clinical development for both subacute cutaneous lupus erythematosus and systemic lupus erythematosus. It has not been approved by the FDA. The program includes multiple Phase 3 trials, with some actively enrolling by invitation and others no longer recruiting.
Litifilimab is being evaluated in several clinical trials, including NCT06044337, a Phase 3 long-term extension study in cutaneous lupus erythematosus; NCT05531565, a Phase 2 study in cutaneous lupus; NCT05352919, a Phase 3 long-term extension in systemic lupus erythematosus; and NCT04961567, a Phase 3 study in systemic lupus erythematosus. These trials are randomized, double-blind, and placebo-controlled.
Yes, litifilimab is also known as BIIB059. BIIB059 is the internal code used by Biogen during development, while litifilimab is the international nonproprietary name. Both refer to the same investigational monoclonal antibody targeting CLEC4C.