ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Healthy Volunteers Drug: BIIB059 Drug: Placebo Phase 1

Detailed Description:
Part 1 (single ascending dose in healthy volunteers) has closed to enrollment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus
Actual Study Start Date : April 30, 2014
Actual Primary Completion Date : May 24, 2016
Actual Study Completion Date : May 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Part 1, Cohort 1: BIIB059 0.05 mg/kg IV
BIIB059 0.05 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 2: BIIB059 0.3 mg/kg IV
BIIB059 0.3 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 3: BIIB059 1 mg/kg IV
BIIB059 1 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 4: BIIB059 3 mg/kg IV
BIIB059 3 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 5: BIIB059 10 mg/kg IV
BIIB059 10 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 6: BIIB059 20 mg/kg IV
BIIB059 20 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Experimental: Part 1, Cohort 7: BIIB059 50 mg SC
BIIB059 50 mg SC dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Placebo Comparator: Part 1, Cohort 1-6: Placebo IV
Matching placebo IV dose, Once on Day 1
Drug: Placebo
See Arm Descriptions

Placebo Comparator: Part 1, Cohort 7: Placebo SC
Matching placebo SC dose, Once on Day 1
Drug: Placebo
See Arm Descriptions

Experimental: Part 2, Cohort 8: BIIB059 20 mg/kg IV
BIIB059 20 mg/kg IV dose, Once on Day 1
Drug: BIIB059
See Arm Descriptions

Placebo Comparator: Part 2, Cohort 8: Placebo IV
Matching placebo IV dose, Once on Day 1
Drug: Placebo
See Arm Descriptions

Experimental: Part 3a, Cohort 9: BIIB059 20 mg SC
BIIB059 20 mg SC dose, Every 4 weeks for 2 doses
Drug: BIIB059
See Arm Descriptions

Experimental: Part 3a, Cohort 10: BIIB059 50 mg SC
BIIB059 50 mg SC dose, Every 4 weeks for 2 doses
Drug: BIIB059
See Arm Descriptions

Experimental: Part 3a, Cohort 11: BIIB059 150 mg SC
BIIB059 150 mg SC dose, Every 4 weeks for 2 doses
Drug: BIIB059
See Arm Descriptions

Experimental: Part 3a, Cohort 12: BIIB059 300 mg or less SC
BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses
Drug: BIIB059
See Arm Descriptions

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
Drug: Placebo
See Arm Descriptions

Experimental: Part 3b, Cohort 13: BIIB059 50 mg SC
BIIB059 50 mg SC dose, Every 4 weeks for 2 doses
Drug: BIIB059
See Arm Descriptions

Experimental: Part 3b, Cohort 14: BIIB059 300 mg or less SC
BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses
Drug: BIIB059
See Arm Descriptions

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
Drug: Placebo
See Arm Descriptions




Primary Outcome Measures :
  1. Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 32 ]

Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of BIIB059 [ Time Frame: Up to Week 32 ]
  2. Maximum Observed Concentration (Cmax) of BIIB059 [ Time Frame: Up to Week 32 ]
  3. Time to Reach Maximum Observed Concentration (Tmax) of BIIB059 [ Time Frame: Up to Week 32 ]
  4. Terminal Elimination Half-Life (t1/2) of BIIB059 [ Time Frame: Up to Week 32 ]
  5. Clearance (CL) of BIIB059 [ Time Frame: Up to Week 32 ]
  6. Apparent Clearance (CL/F) of BIIB059 [ Time Frame: Up to Week 32 ]
    For SC cohorts only

  7. Volume of Distribution (Vss) of BIIB059 [ Time Frame: Up to Week 32 ]
  8. Apparent Volume of Distribution (Vz/F) of BIIB059 [ Time Frame: Up to Week 32 ]
    For SC cohorts only

  9. Bioavailability (F) for a single SC dose of BIIB059 [ Time Frame: Up to Week 32 ]
  10. Absorption Rate Profile for a Single SC Dose of BIIB059 [ Time Frame: Up to Week 32 ]
  11. Number of Participants Who Develop Serum Anti-BIIB059 Antibodies [ Time Frame: Up to Week 32 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106897


Locations
United States, Alabama
Research Site
Anniston, Alabama, United States, 36207
Research Site
Birmingham, Alabama, United States, 35294
United States, Florida
Research Site
Orlando, Florida, United States, 32806
United States, New York
Research Site
Great Neck, New York, United States, 11021
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02106897     History of Changes
Other Study ID Numbers: 230LE101
2013-005361-39 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases