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NCT03371251 · ClinicalTrials.gov registry record · Phase 1
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
A Phase 1 study, sponsored by Boston Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
NCT03371251: Completed Phase 1 study, sponsored by Boston Pharmaceuticals.
NCT03371251 is a Phase 1 study that has completed, run by Boston Pharmaceuticals. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03371251, a Phase 1 study, has completed, sponsored by Boston Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
Study Summary
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams \[mg\], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose. BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.
Primary Outcome
The safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20, 60, and 120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment, in order to estimate the optimal dose.
Interventions
- DRUG Placebo
- DRUG BOS161721
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2018-01-10 |
| Est. Completion | 2020-11-26 |
| Phase | Phase 1 |
What the finished NCT03371251 record still lists
NCT03371251 is an interventional study that assigns participants to a tested intervention. The registered 143 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 (138% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03371251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03371251 about?
NCT03371251 is a clinical study titled "Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care". This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams \[mg\], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background sta...
What is the current status of trial NCT03371251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2018-01-10. Estimated completion is 2020-11-26.
What interventions are being tested in trial NCT03371251?
The interventions under investigation include: Placebo (DRUG), BOS161721 (DRUG).
Who is sponsoring clinical trial NCT03371251?
This trial is sponsored by Boston Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03371251's enrollment target sits among peer trials
143 401st of 2000 higher than 1,600 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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