Clincosm LogoSign in Get a demo

Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05248659
Collaborator
(none)
600
Enrollment
1
Location
1
Arm
81.9
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2/3 open-label study to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sibeprenlimab 400 mg s.c. Q4weeks
 Phase 2/Phase 3

Detailed Description

This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.

Subjects who have not previously received sibeprenlimab will not be enrolled in this trial.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2/3, Multicenter, Open-label Extension Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 28, 2028
Anticipated Study Completion Date :
Dec 28, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks

Drug: Sibeprenlimab 400 mg s.c. Q4weeks
Sibeprenlimab 400 mg s.c. q 4 weeks
Other Names:
  • VIS649

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [From baseline to the end-of-trial visit in Week 112.]

    Secondary Outcome Measures

    1. Annualized slope of Estimated Glomerular Filtration Rate (eGFR) [Over 12 and 24 months]

    2. Urine protein/creatinine ratio (uPCR) in a 24-hour collection [At 12 and 24 months]

    3. Proportion of Subjects with Clinical Remission as defined in the protocol [At 12 and 24 months]

    4. Time to Progression of Chronic Kidney Disease, as defined in the protocol [Over 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.

    • eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

    Exclusion Criteria:

    • Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.

    • Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding sites, contact 844-687-8522 New York New York United States 10001

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Development & Commercialization, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    ClinicalTrials.gov Identifier:
    NCT05248659
    Other Study ID Numbers:
    • 417-201-00012
    First Posted:
    Feb 21, 2022
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sibeprenlimab
    VIS649
    IgAN
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, IGA

    Study Results

    No Results Posted as of Feb 21, 2022