Trials / Completed
CompletedNCT04835441
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALPN-101 | Intravenous infusion via an infusion pump. |
| DRUG | Placebo | Intravenous infusion via an infusion pump. |
Timeline
- Start date
- 2021-06-22
- Primary completion
- 2024-07-09
- Completion
- 2024-07-09
- First posted
- 2021-04-08
- Last updated
- 2025-08-15
- Results posted
- 2025-08-15
Locations
46 sites across 7 countries: United States, France, Hungary, Poland, Puerto Rico, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04835441. Inclusion in this directory is not an endorsement.