About the study

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 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:

Inclusion criteria

1. Written informed consent
2. Age 18 to 65
3. Diagnosis of lupus for ≥ 6 months prior to Screening
4. Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening
5. 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
6. Standard lupus medications must be stable prior to Screening
7. Women must have a PAP smear and known HPV status within 12 months of Day 1
8. All participants must use highly effective birth control if they/their partner are capable of becoming pregnant

Exclusion criteria

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. Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes
6. Recent or serious ongoing infection; risk or history of serious infection
7. Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
8. Unacceptable Screening laboratory results
9. History of new, ongoing, or recurrent malignancy ≤ 5 years prior to Day 1, with some exceptions per-protocol
10. Pregnant or breastfeeding at the time of screening, or plans to become pregnant ≤ 3 months following the last dose of study drug
11. 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
12. Diagnosis of, or fulfills diagnostic criteria for, fibromyalgia
13. Functional class IV lupus
14. Does not meet protocol washout periods for concomitant medications
15. 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
16. Ongoing participation in another therapeutic clinical trial
17. Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.