ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

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)

Timeline

Start

2021-06-22

Primary completion

2024-07-09

Completion

2024-07-09

Outcome

Missed primary endpoint

registry analysis (superiority test); ALPN-101 (Acazicolcept) vs Placebo; p = 0.107; Cochran-Mantel-Haenszel NCT04835441 ↗

registry analysis (superiority test); ALPN-101 (Acazicolcept) vs Placebo; p = 0.308; Cochran-Mantel-Haenszel NCT04835441 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACAZICOLCEPT	Protein / enzyme biologic	3 mg/kg	Intravenous

Indications