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

NCT ID: NCT05248659

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2028-12-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Immunoglobulin A Nephropathy

Keywords

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Sibeprenlimab VIS649 IgAN

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sibeprenlimab 400 mg s.c. q 4 weeks

Group Type EXPERIMENTAL

Sibeprenlimab 400 mg s.c. Q4weeks

Intervention Type DRUG

Sibeprenlimab 400 mg s.c. q 4 weeks

Interventions

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Sibeprenlimab 400 mg s.c. Q4weeks

Sibeprenlimab 400 mg s.c. q 4 weeks

Intervention Type DRUG

Other Intervention Names

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VIS649

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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For additional information regarding sites, contact 844-687-8522

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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417-201-00012

Identifier Type: -

Identifier Source: org_study_id