Phase 2
N=76
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT04835441 ↗Enrolled (actual)
76
Serious AEs
5.3%
Results posted
Aug 2025
Primary outcome: Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 23; 24; 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALPN-101 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
23; 24; 2; 2 | — |
| PRIMARY Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 |
27; 46 | 0.107 |
| PRIMARY Percentage of Participants Achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response |
22; 32 | 0.308 |
| SECONDARY Annualized Flare Rate by British Isles Lupus Assessment Group (BILAG)-2004 Flare Index |
3.27; 2.80 | 0.442 |
| SECONDARY Time-to-first Flare by BILAG-2004 Flare Index |
85.0; 113.0 | 0.788 |
| SECONDARY Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) |
14; 16 | 0.792 |
| SECONDARY Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score |
-2.4; -3.0 | 0.302 |
| SECONDARY Cumulative Prednisone-equivalent Dose Use Through Day 169 |
1028.28; 854.59 | 0.506 |
| SECONDARY Percentage of Participants With ≥ 50% Reduction In CLASI Activity Score In Participants With Baseline CLASI Activity Score ≥ 8 |
30; 45 | 0.659 |
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04835441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.