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NCT02106897 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT02106897 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 109 participants.
The verdict
NCT02106897, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG BIIB059 (litifilimab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2014-04-30 |
| Est. Completion | 2016-05-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02106897
The ClinicalTrials.gov registry entry for NCT02106897 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02106897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02106897 about?
NCT02106897 is a clinical study titled "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". 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). Th...
What is the current status of trial NCT02106897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2014-04-30. Estimated completion is 2016-05-24.
What interventions are being tested in trial NCT02106897?
The interventions under investigation include: Placebo (DRUG), BIIB059 (litifilimab) (DRUG).
Who is sponsoring clinical trial NCT02106897?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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