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ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

NCT04835441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-08-15

Study results available
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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

DRUG

ALPN-101

Intravenous infusion via an infusion pump.

DRUG

Placebo

Intravenous infusion via an infusion pump.

Sponsors & Collaborators

  • Alpine Immune Sciences Inc, A Subsidiary of Vertex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2024-07-09
Completion
2024-07-09
FDA Drug
Yes

Countries

  • United States
  • France
  • Hungary
  • Poland
  • Puerto Rico
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835441 on ClinicalTrials.gov