Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus ErythematosusHealthy Volunteers
- Interventions
- Drug: BIIB059 (litifilimab)Drug: Placebo
- Registration Number
- NCT02106897
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE.
Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059 in participants with SLE; To estimate the PK parameters and bioavailability (F) of a single SC dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059 administered to healthy volunteers and participants with SLE. Secondary objectives of Part 3 are as follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE; To evaluate the immunogenicity of BIIB059 administered SC to healthy volunteers and participants with SLE.
- Detailed Description
Part 1 (single ascending dose in healthy volunteers) has closed to enrollment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1, Cohort 5: BIIB059 10 mg/kg IV BIIB059 (litifilimab) BIIB059 10 mg/kg IV dose, Once on Day 1 Part 1, Cohort 1-6: Placebo IV Placebo Matching placebo IV dose, Once on Day 1 Part 2, Cohort 8: Placebo IV Placebo Matching placebo IV dose, Once on Day 1 Part 1, Cohort 1: BIIB059 0.05 mg/kg IV BIIB059 (litifilimab) BIIB059 0.05 mg/kg IV dose, Once on Day 1 Part 3a, Cohort 9: BIIB059 20 mg SC BIIB059 (litifilimab) BIIB059 20 mg SC dose, Every 4 weeks for 2 doses Part 1, Cohort 3: BIIB059 1 mg/kg IV BIIB059 (litifilimab) BIIB059 1 mg/kg IV dose, Once on Day 1 Part 1, Cohort 6: BIIB059 20 mg/kg IV BIIB059 (litifilimab) BIIB059 20 mg/kg IV dose, Once on Day 1 Part 1, Cohort 7: BIIB059 50 mg SC BIIB059 (litifilimab) BIIB059 50 mg SC dose, Once on Day 1 Part 3a, Cohort 9-12: Placebo SC Placebo Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses Part 3b, Cohort 14: BIIB059 300 mg or less SC BIIB059 (litifilimab) BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses Part 1, Cohort 2: BIIB059 0.3 mg/kg IV BIIB059 (litifilimab) BIIB059 0.3 mg/kg IV dose, Once on Day 1 Part 2, Cohort 8: BIIB059 20 mg/kg IV BIIB059 (litifilimab) BIIB059 20 mg/kg IV dose, Once on Day 1 Part 3a, Cohort 10: BIIB059 50 mg SC BIIB059 (litifilimab) BIIB059 50 mg SC dose, Every 4 weeks for 2 doses Part 3a, Cohort 11: BIIB059 150 mg SC BIIB059 (litifilimab) BIIB059 150 mg SC dose, Every 4 weeks for 2 doses Part 3a, Cohort 12: BIIB059 300 mg or less SC BIIB059 (litifilimab) BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses Part 1, Cohort 4: BIIB059 3 mg/kg IV BIIB059 (litifilimab) BIIB059 3 mg/kg IV dose, Once on Day 1 Part 1, Cohort 7: Placebo SC Placebo Matching placebo SC dose, Once on Day 1 Part 3b, Cohort 13: BIIB059 50 mg SC BIIB059 (litifilimab) BIIB059 50 mg SC dose, Every 4 weeks for 2 doses Part 3b, Cohort 13-14: Placebo SC Placebo Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses
- Primary Outcome Measures
Name Time Method Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Week 32
- Secondary Outcome Measures
Name Time Method Apparent Clearance (CL/F) of BIIB059 Up to Week 32 For SC cohorts only
Time to Reach Maximum Observed Concentration (Tmax) of BIIB059 Up to Week 32 Terminal Elimination Half-Life (t1/2) of BIIB059 Up to Week 32 Clearance (CL) of BIIB059 Up to Week 32 Volume of Distribution (Vss) of BIIB059 Up to Week 32 Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of BIIB059 Up to Week 32 Maximum Observed Concentration (Cmax) of BIIB059 Up to Week 32 Apparent Volume of Distribution (Vz/F) of BIIB059 Up to Week 32 For SC cohorts only
Bioavailability (F) for a single SC dose of BIIB059 Up to Week 32 Number of Participants Who Develop Serum Anti-BIIB059 Antibodies Up to Week 32 Absorption Rate Profile for a Single SC Dose of BIIB059 Up to Week 32
Trial Locations
- Locations (1)
Research Site
🇺🇸Duncansville, Pennsylvania, United States