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ALPN-101 in Systemic Lupus Erythematosus (Synergy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04835441
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: ALPN-101 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALPN-101 Drug: ALPN-101
Blinded ALPN-101 will be administered
Placebo Comparator: Placebo Drug: Placebo
Blinded placebo matching ALPN-101 will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: From study Day 1 until End of Study (28 weeks) ]
    Type, incidence, and severity of adverse events as assessed by CTCAE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835441


Contacts
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Contact: Marcus Martin 1 404 309 8902 Marcus.Martin@parexel.com

Locations
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Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Rachel Peterson, MD Alpine Immune Sciences, Inc.
More Information
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04835441    
Other Study ID Numbers: AIS-A03
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpine Immune Sciences, Inc.:
CD28
ICOS
Autoimmune disease
Immune system disease
Immunosuppressive agent
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases