Healthy Volunteers, Systemic Lupus Erythematosus
Conditions
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.
Interventions
See Arm Descriptions
DRUGPlacebo
See Arm Descriptions
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part 1: Key Inclusion Criteria For Healthy Volunteers: * Be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG. * Body mass index (BMI) between 18 and 30 kg/m2 and body weight ≥45 kg. Part 1: Key
Exclusion criteria
For Healthy Volunteers: * History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]). * \- History of chronic, recurrent, or recent serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within 3 months prior to screening and randomization. * History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug. * History of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator. * Any live or attenuated immunization/vaccination within 1 month prior to randomization or planned to occur during the study period. * Blood donation (1 unit or more) within 1 month prior to randomization. * Vigorous exercise (e.g., jogging, swimming laps, heavy gardening, hiking uphill, etc.) within 48 hours prior to Day -1 Part II: Key Inclusion Criteria for SLE Participants: * Definite SLE for at least 6 months duration or anti-dsDNA antibody, prior to screening. * Presence of active lupus skin disease including acute, sub acute, and/or chronic cutaneous lupus (e.g., discoid) at the time of screening and randomization. * BMI between 18 and \<40 kg/m2 and body weight ≥45 kg. Part II: Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 32 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BIIB059 | Up to Week 32 | — |
| 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 | — |
| Apparent Clearance (CL/F) of BIIB059 | Up to Week 32 | For SC cohorts only |
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) 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 | — |
| Absorption Rate Profile for a Single SC Dose of BIIB059 | Up to Week 32 | — |
| Number of Participants Who Develop Serum Anti-BIIB059 Antibodies | Up to Week 32 | — |
| Volume of Distribution (Vss) of BIIB059 | Up to Week 32 | — |
Countries
United States
Outcome results
None listed