For Healthcare Professionals

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus


About the study

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)

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria Summary

  1. SLE onset ≥ 6 months prior to Screening
  2. Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
  3. Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
  4. Standard lupus medications must be stable prior to Screening


Key Exclusion Criteria Summary:

  1. Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
  2. Proteinuria consistent with nephrotic syndrome
  3. Active lupus-related neuropsychiatric disease
  4. Drug-induced lupus
  5. Recent or serious ongoing infection; risk or history of serious infection
  6. Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
  7. Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
  8. Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
  9. Functional class IV
  10. Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Systemic Lupus Erythematosus

Age (in years)

18 - 70


Phase 2

Participants needed


Est. Completion Date

Jan 31, 2025

Treatment type



Alpine Immune Sciences, Inc. identifier


Study number


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