Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
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ClinicalTrials.gov Identifier: NCT03945318 |
Recruitment Status :
Active, not recruiting
First Posted : May 10, 2019
Last Update Posted : April 19, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | April 21, 2019 | ||||||
First Posted Date ICMJE | May 10, 2019 | ||||||
Last Update Posted Date | April 19, 2024 | ||||||
Actual Study Start Date ICMJE | April 8, 2019 | ||||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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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 | Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) | ||||||
Official Title ICMJE | A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy | ||||||
Brief Summary | Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN). | ||||||
Detailed Description | This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. The study will be conducted in three parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period Parts 1 and 2 have been completed. Part 3 enrollment is complete. Part 4 enrollment is open for eligible participants from Part 3. The study will enroll up to 40 participants with IgAN. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Part 1 (SAD-HV) is a randomized, placebo-controlled single ascending dose design in HVs. Part 2 (MAD-HV): is a randomized, placebo-controlled multiple ascending dose design in HVs. Part 3 (MD-IgAN) is an open-label multiple dose design in participants with IgAN. Part 4 (IgAN) is open-label retreatment for Part 3 participants. Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Parts 1 and 2 will be performed in a double-blind manner, for clinical research personnel interacting with study participants. An unblinded pharmacist will prepare the doses of investigational study drugs. Primary Purpose: Treatment
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Condition ICMJE | IgA Nephropathy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
103 | ||||||
Original Estimated Enrollment ICMJE |
73 | ||||||
Estimated Study Completion Date ICMJE | October 2026 | ||||||
Estimated Primary Completion Date | October 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Healthy Volunteers:
Inclusion Criteria for Adults with IgAN:
Exclusion Criteria for Adults with IgAN:
PART 4 Eligibility Criteria for Re-treatment Due to Evidence of Disease Progression (Option 1) Inclusion Criteria for Re-treatment Due to Evidence of Disease Progression
Exclusion Criteria for Re-treatment Due to Evidence of Disease Progression 1. Based on the Investigator's judgment, the patient would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual patient which outweighs the expected benefit from resuming treatment. Eligibility Criteria for Optional Re-treatment (Option 2) Inclusion Criteria for Optional Re-treatment 1. Completed Part 3 of the study through Week 124 and completed of the 52-week follow-up period. Exclusion Criteria for Optional Re-treatment 1. Based on the Investigator's judgment, the patient would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual patient which outweighs the expected benefit from resuming treatment. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Korea, Republic of, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03945318 | ||||||
Other Study ID Numbers ICMJE | ADU-CL-19 2018-003360-31 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Chinook Therapeutics, Inc. | ||||||
Original Responsible Party | Aduro Biotech, Inc. | ||||||
Current Study Sponsor ICMJE | Chinook Therapeutics, Inc. | ||||||
Original Study Sponsor ICMJE | Aduro Biotech, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Chinook Therapeutics, Inc. | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |