A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus (Synergy)

  • STATUS
    Recruiting
  • End date
    Jan 19, 2024
  • participants needed
    130
  • sponsor
    Alpine Immune Sciences, Inc.
Updated on 19 September 2022
Investigator
Meghan Novy
Primary Contact
Investigational Site (151) (7.9 mi away) Contact
+57 other location
lupus
human papilloma virus vaccine

Summary

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)

Details
Condition Systemic Lupus Erythematosus
Treatment Placebo, ALPN-101
Clinical Study IdentifierNCT04835441
SponsorAlpine Immune Sciences, Inc.
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes
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
Unacceptable Screening laboratory results
History of new, ongoing, or recurrent malignancy ≤ 5 years prior to Day 1, with some exceptions per-protocol
Pregnant or breastfeeding at the time of screening, or plans to become pregnant ≤ 3 months following the last dose of study drug
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 lupus
Does not meet protocol washout periods for concomitant medications
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
Ongoing participation in another therapeutic clinical trial
Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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