Trials / Completed
CompletedNCT03371251
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- Boston Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BOS161721 | SC administration |
| DRUG | Placebo | SC administration |
Timeline
- Start date
- 2018-01-10
- Primary completion
- 2020-11-26
- Completion
- 2020-11-26
- First posted
- 2017-12-13
- Last updated
- 2022-03-14
- Results posted
- 2022-03-14
Locations
68 sites across 12 countries: United States, Argentina, Bulgaria, Colombia, Georgia, Hungary, Mexico, Peru, Philippines, Poland, Romania, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03371251. Inclusion in this directory is not an endorsement.