Study of BHV-1400 in IgA Nephropathy

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

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site-007, Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Participants must have biopsy-confirmed IgA Nephropathy

Key Exclusion Criteria:

Any secondary IgAN
Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause

Treatment and study plan

BHV-1400

Drug

BHV-1400 is delivered subcutaneously (SC)

Primary outcomes

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

Time frame: Up to 1 year

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

Time frame: Up to 1 year

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer

CONTACT

[email protected]

203-404-0410

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jul 8, 2025
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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