Open-Label Extension Study of BION-1301 in IgA Nephropathy

Last updated: December 22, 2020
Sponsor: Chinook Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Nephritis

Kidney Disease

Nephropathy

Treatment

N/A

Clinical Study ID

NCT04684745
ADU-CL-24
  • Ages > 18
  • All Genders

Study Summary

This is an open-label extension (OLE) study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of BION-1301 in adults with IgA nephropathy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participated in Study ADU-CL-19 and received at least 5 of 7 doses if enrolled inCohort 1 (dosed once every 2 weeks) and 3 of 4 doses if enrolled in Cohort 2 (dosedonce every 4 weeks).
  • Male or female ≥18 years old at Screening
  • Males must agree to follow the protocol-specified contraception guidance throughoutthe study (from Screening through 10 weeks after the final dose of study drug)
  • Women of child-bearing potential (WOCBP) must agree to follow the protocol-specifiedcontraception guidance throughout the study (from Screening through 10 weeks after thefinal dose of study drug)
  • Able to provide signed informed consent

Exclusion

Exclusion Criteria:

  • Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) orany other form of immunosuppressive therapy within 3 months prior to the first dose ofstudy drug
  • Female who is breastfeeding
  • Type 1 or 2 diabetes
  • Current malignancy or history of malignancy during the last 3 years
  • Known or suspected allergy or hypersensitivity to any component of BION-1301, orhistory of severe hypersensitivity reaction to any monoclonal antibody

Study Design

Total Participants: 20
Study Start date:
September 10, 2020
Estimated Completion Date:
November 30, 2023

Study Description

This is a Phase 2, multicenter, open-label extension (OLE) study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody.

Patients who previously participated in Study ADU-CL-19 (NCT03945318) will receive open-label treatment with BION-1301 for up to approximately 2 years. Study participants will receive BION-1301 at the same dose, route, and dosing schedule as they received in ADU-CL-19. Dose, route, and/or dosing schedule may be changed during the OLE study based on a review by the Safety Review Team of all available PK, PD, and clinical activity data from previous and ongoing studies of BION-1301.

Connect with a study center

  • Amicis Research Center

    Northridge, California 91324
    United States

    Active - Recruiting

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