Status:
COMPLETED
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Lead Sponsor:
Alpine Immune Sciences Inc, A Subsidiary of Vertex
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 wit...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria Summary
- SLE onset ≥ 6 months prior to Screening
- Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
- 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
- Standard lupus medications must be stable prior to Screening
- Key Exclusion Criteria Summary:
- Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
- Proteinuria consistent with nephrotic syndrome
- Active lupus-related neuropsychiatric disease
- Drug-induced lupus
- Recent or serious ongoing infection; risk or history of serious infection
- Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
- 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
- Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
- Functional class IV
- 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
Exclusion
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04835441
Start Date
June 22 2021
End Date
July 9 2024
Last Update
August 15 2025
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site (107)
Anniston, Alabama, United States, 36207
2
Investigational Site (189)
Phoenix, Arizona, United States, 85037
3
Investigational Site (155)
Los Angeles, California, United States, 90022
4
Investigational Site (109)
San Diego, California, United States, 92020