Study of BHV-1400 in IgA Nephropathy

Phase 1RecruitingNCT07054684

Biohaven Therapeutics Ltd.20 enrolled

Overview

The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgA Nephropathy

Interventions

BHV-1400DRUG

BHV-1400 is delivered subcutaneously (SC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1\. Participants must have biopsy-confirmed IgA Nephropathy Key Exclusion Criteria: 1. Any secondary IgAN 2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause

Locations (15)

Site-001

Farmington, Connecticut, United States

RECRUITING

Site-003

Miami Lakes, Florida, United States

Outcomes

Primary Outcomes

Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths

To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths

Time frame: Up to 1 year

Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities

To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.

Time frame: Up to 1 year

Central Contacts

Chief Medical Officer

CONTACT

203-404-0410 clinicaltrials@biohavenpharma.com

Data from ClinicalTrials.gov

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