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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: Completed Phase 1 study, sponsored by Biogen.
NCT02106897 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02106897 record still lists
NCT02106897 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02106897 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02106897's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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