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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 is a Phase 1 study that has completed, run by Boston Pharmaceuticals. The registered enrollment target is 143 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03371251
The ClinicalTrials.gov registry entry for NCT03371251 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03371251 reports 0 study locations.
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.
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