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ALPN-101 (Acazicolcept) 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 : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE April 5, 2021
First Posted Date  ICMJE April 8, 2021
Last Update Posted Date May 3, 2023
Actual Study Start Date  ICMJE June 22, 2021
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2021)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2021)		 Adverse Events [ Time Frame: For 28 weeks, starting on Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: ALPN-101
    Blinded ALPN-101 will be administered
  • Drug: Placebo
    Blinded placebo matching ALPN-101 will be administered.
Study Arms  ICMJE
  • Experimental: ALPN-101 (acazicolcept)
    Intervention: Drug: ALPN-101
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2021)		 130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcus Martin 1 404 309 8902 Marcus.Martin@parexel.com
Listed Location Countries  ICMJE France,   Hungary,   Korea, Republic of,   Poland,   Puerto Rico,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04835441
Other Study ID Numbers  ICMJE AIS-A03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alpine Immune Sciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alpine Immune Sciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rachel Peterson, MD Alpine Immune Sciences, Inc.
PRS Account Alpine Immune Sciences, Inc.
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP