ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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)

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: ALPN-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALPN-101 (acazicolcept)<br> | Drug: ALPN-101<br>* Blinded ALPN-101 will be administered<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Blinded placebo matching ALPN-101 will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Type, incidence, and severity of adverse events as assessed by CTCAE | From study Day 1 until End of Study (28 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD28, ICOS, Autoimmune disease, Immune system disease, Immunosuppressive agent