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

NCT02106897 | Completed Phase 1

• 2 other identifiers: 230LE1012013-005361-39
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 5

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.

Conditions

Systemic Lupus Erythematosus; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 32

Secondary Outcomes (11)

• 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

• 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

Study Arms (19)

Part 1, Cohort 1: BIIB059 0.05 mg/kg IV

EXPERIMENTAL

BIIB059 0.05 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 2: BIIB059 0.3 mg/kg IV

EXPERIMENTAL

BIIB059 0.3 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 3: BIIB059 1 mg/kg IV

EXPERIMENTAL

BIIB059 1 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 4: BIIB059 3 mg/kg IV

EXPERIMENTAL

BIIB059 3 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 5: BIIB059 10 mg/kg IV

EXPERIMENTAL

BIIB059 10 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 6: BIIB059 20 mg/kg IV

EXPERIMENTAL

BIIB059 20 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 7: BIIB059 50 mg SC

EXPERIMENTAL

BIIB059 50 mg SC dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 1, Cohort 1-6: Placebo IV

PLACEBO COMPARATOR

Matching placebo IV dose, Once on Day 1

Drug: Placebo

Part 1, Cohort 7: Placebo SC

PLACEBO COMPARATOR

Matching placebo SC dose, Once on Day 1

Drug: Placebo

Part 2, Cohort 8: BIIB059 20 mg/kg IV

EXPERIMENTAL

BIIB059 20 mg/kg IV dose, Once on Day 1

Drug: BIIB059 (litifilimab)

Part 2, Cohort 8: Placebo IV

PLACEBO COMPARATOR

Matching placebo IV dose, Once on Day 1

Drug: Placebo

Part 3a, Cohort 9: BIIB059 20 mg SC

EXPERIMENTAL

BIIB059 20 mg SC dose, Every 4 weeks for 2 doses

Drug: BIIB059 (litifilimab)

Part 3a, Cohort 10: BIIB059 50 mg SC

EXPERIMENTAL

BIIB059 50 mg SC dose, Every 4 weeks for 2 doses

Drug: BIIB059 (litifilimab)

Part 3a, Cohort 11: BIIB059 150 mg SC

EXPERIMENTAL

BIIB059 150 mg SC dose, Every 4 weeks for 2 doses

Drug: BIIB059 (litifilimab)

Part 3a, Cohort 12: BIIB059 300 mg or less SC

EXPERIMENTAL

BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses

Drug: BIIB059 (litifilimab)

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

Drug: Placebo

Part 3b, Cohort 13: BIIB059 50 mg SC

EXPERIMENTAL

BIIB059 50 mg SC dose, Every 4 weeks for 2 doses

Drug: BIIB059 (litifilimab)

Part 3b, Cohort 14: BIIB059 300 mg or less SC

EXPERIMENTAL

BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses

Drug: BIIB059 (litifilimab)

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

Drug: Placebo

Interventions

BIIB059 (litifilimab) DRUG

See Arm Descriptions

Also known as: litifilimab

Part 1, Cohort 1: BIIB059 0.05 mg/kg IV; Part 1, Cohort 2: BIIB059 0.3 mg/kg IV; Part 1, Cohort 3: BIIB059 1 mg/kg IV; Part 1, Cohort 4: BIIB059 3 mg/kg IV; Part 1, Cohort 5: BIIB059 10 mg/kg IV; Part 1, Cohort 6: BIIB059 20 mg/kg IV; Part 1, Cohort 7: BIIB059 50 mg SC; Part 2, Cohort 8: BIIB059 20 mg/kg IV; Part 3a, Cohort 10: BIIB059 50 mg SC; Part 3a, Cohort 11: BIIB059 150 mg SC; Part 3a, Cohort 12: BIIB059 300 mg or less SC; Part 3a, Cohort 9: BIIB059 20 mg SC; Part 3b, Cohort 13: BIIB059 50 mg SC; Part 3b, Cohort 14: BIIB059 300 mg or less SC

Placebo DRUG

See Arm Descriptions

Part 1, Cohort 1-6: Placebo IV; Part 1, Cohort 7: Placebo SC; Part 2, Cohort 8: Placebo IV; Part 3a, Cohort 9-12: Placebo SC; Part 3b, Cohort 13-14: Placebo SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Active neuropsychiatric SLE including but not limited to the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confusional state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes.
• 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.
• Symptoms of bacterial or viral infection (including upper respiratory tract infection) within 28 days prior to randomization.
• History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug.
• Evidence of skin conditions other than lupus skin disease (e.g., eczema) at screening or at the time of randomization that would interfere with evaluations of the effect of study treatment on lupus skin disease.

Sponsors & Collaborators

• Biogen: lead

Study Sites (5)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Birmingham, Alabama, 35294, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Great Neck, New York, 11021, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

• Furie R, Werth VP, Merola JF, Stevenson L, Reynolds TL, Naik H, Wang W, Christmann R, Gardet A, Pellerin A, Hamann S, Auluck P, Barbey C, Gulati P, Rabah D, Franchimont N. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. J Clin Invest. 2019 Mar 1;129(3):1359-1371. doi: 10.1172/JCI124466. Epub 2019 Feb 18.

  PMID: 30645203 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: April 30, 2014
• Primary Completion: May 24, 2016
• Study Completion: May 24, 2016
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

US (5)