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Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02106897
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE April 4, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE April 30, 2014
Actual Primary Completion Date May 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 32 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • Number of participants that experience adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 20 ]
  • The number of participants who develop serum anti-BIIB059 antibodies [ Time Frame: Up to Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Maximum Observed Concentration (Cmax) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Time to Reach Maximum Observed Concentration (Tmax) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Terminal Elimination Half-Life (t1/2) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Clearance (CL) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Apparent Clearance (CL/F) of BIIB059 [ Time Frame: Up to Week 32 ]
    For SC cohorts only
  • Volume of Distribution (Vss) of BIIB059 [ Time Frame: Up to Week 32 ]
  • Apparent Volume of Distribution (Vz/F) of BIIB059 [ Time Frame: Up to Week 32 ]
    For SC cohorts only
  • Bioavailability (F) for a single SC dose of BIIB059 [ Time Frame: Up to Week 32 ]
  • Absorption Rate Profile for a Single SC Dose of BIIB059 [ Time Frame: Up to Week 32 ]
  • Number of Participants Who Develop Serum Anti-BIIB059 Antibodies [ Time Frame: Up to Week 32 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Maximum observed concentration (Cmax) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Time to reach maximum observed concentration (Tmax) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Terminal elimination half-life (t1/2) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Clearance (CL) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Apparent clearance (CL/F) [for SC only] of BIIB059 [ Time Frame: Up to Week 16 ]
  • Volume of distribution (Vss) of BIIB059 [ Time Frame: Up to Week 16 ]
  • Apparent volume of distribution (Vz/F) [for SC only] of BIIB059 [ Time Frame: Up to Week 16 ]
  • F (Bioavailability) for a single SC dose of BIIB059 [ Time Frame: Up to Week 16 ]
  • Absorption rate profile for a single SC dose of BIIB059 [ Time Frame: Up to Week 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
Official Title  ICMJE A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Healthy Volunteers
Intervention  ICMJE
  • Drug: BIIB059
    See Arm Descriptions
  • Drug: Placebo
    See Arm Descriptions
Study Arms  ICMJE
  • Experimental: Part 1, Cohort 1: BIIB059 0.05 mg/kg IV
    BIIB059 0.05 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 2: BIIB059 0.3 mg/kg IV
    BIIB059 0.3 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 3: BIIB059 1 mg/kg IV
    BIIB059 1 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 4: BIIB059 3 mg/kg IV
    BIIB059 3 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 5: BIIB059 10 mg/kg IV
    BIIB059 10 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 6: BIIB059 20 mg/kg IV
    BIIB059 20 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Experimental: Part 1, Cohort 7: BIIB059 50 mg SC
    BIIB059 50 mg SC dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part 1, Cohort 1-6: Placebo IV
    Matching placebo IV dose, Once on Day 1
    Intervention: Drug: Placebo
  • Placebo Comparator: Part 1, Cohort 7: Placebo SC
    Matching placebo SC dose, Once on Day 1
    Intervention: Drug: Placebo
  • Experimental: Part 2, Cohort 8: BIIB059 20 mg/kg IV
    BIIB059 20 mg/kg IV dose, Once on Day 1
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part 2, Cohort 8: Placebo IV
    Matching placebo IV dose, Once on Day 1
    Intervention: Drug: Placebo
  • Experimental: Part 3a, Cohort 9: BIIB059 20 mg SC
    BIIB059 20 mg SC dose, Every 4 weeks for 2 doses
    Intervention: Drug: BIIB059
  • Experimental: Part 3a, Cohort 10: BIIB059 50 mg SC
    BIIB059 50 mg SC dose, Every 4 weeks for 2 doses
    Intervention: Drug: BIIB059
  • Experimental: Part 3a, Cohort 11: BIIB059 150 mg SC
    BIIB059 150 mg SC dose, Every 4 weeks for 2 doses
    Intervention: Drug: BIIB059
  • Experimental: Part 3a, Cohort 12: BIIB059 300 mg or less SC
    BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part 3a, Cohort 9-12: Placebo SC
    Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses
    Intervention: Drug: Placebo
  • Experimental: Part 3b, Cohort 13: BIIB059 50 mg SC
    BIIB059 50 mg SC dose, Every 4 weeks for 2 doses
    Intervention: Drug: BIIB059
  • Experimental: Part 3b, Cohort 14: BIIB059 300 mg or less SC
    BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses
    Intervention: Drug: BIIB059
  • Placebo Comparator: Part 3b, Cohort 13-14: Placebo SC
    Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2016)
109
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
64
Actual Study Completion Date  ICMJE May 24, 2016
Actual Primary Completion Date May 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Exclusion Criteria for SLE Participants:

  • 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.
  • Treatment with oral prednisone >15 mg daily (or equivalent). Any prednisone regimen must be stable for at least 28 days before randomization and expected to remain stable for the duration of the study.
  • Treatment with any antibiotics within 14 days prior to randomization.

Part IIIa: Key Inclusion Criteria for Healthy Volunteers :

  • Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
  • Must have a body mass index (BMI) between 18 and 30 kg/m2 and body weight ≥45 kg.

Part IIIa: Key Exclusion Criteria for Healthy Volunteers:

  • 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 treatment.
  • Treatment with any antibiotics within 14 days prior to randomization.

Part IIIb: Key Inclusion Criteria for SLE Participants:

  • Definite SLE for at least 6 months duration prior to screening
  • Presence of active lupus skin disease including acute, subacute, and/or chronic cutaneous lupus (e.g., discoid), and/or hypocomplementemia , and/or positive anti-dsDNA antibody at the time of screening.
  • Must have a BMI between 18 and <40 kg/m2 and body weight ≥45 kg.

Part IIIb: Key Exclusion Criteria for SLE Participants:

  • 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.
  • History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug.
  • Treatment with any antibiotics within 14 days prior to randomization.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02106897
Other Study ID Numbers  ICMJE 230LE101
2013-005361-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP