At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 76 enrolled
Drug / intervention
ALPN-101 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
Alpine Immune Sciences Inc, A Subsidiary of Vertex·interventional·Posted Apr 8, 2021·Updated Aug 15, 2025
In Brief
A Phase 2 clinical trial evaluating ALPN-101 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 76 participants across 46 sites in 7 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesFrance, Hungary, Poland, Puerto Rico, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartJun 2021
Primary CompletionJul 2024
TodayJul 2026
First PostedApr 8, 2021
Enrollment StartJun 22, 2021
Primary CompletionJul 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.2 years ago
Interventions
ALPN-101drug
Intravenous infusion via an infusion pump.
Placebodrug
Intravenous infusion via an infusion pump.