A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy

The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: BHV-1400; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chief Medical Officer; Phone Number: 203-404-0410; Email: clinicaltrials@biohavenpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.

  • If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.
  • In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.
• UPCR ≥ 0.75 g/g or UPE ≥ 1.0 g/d determined via 24 hour collection.
• eGFR ≥ 30 mL/min/1.73m2 (CKD-EPI equation).
• Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.
• Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.

Key Exclusion Criteria:

• Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.
• Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor/Sponsor Designee.
• Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.
• Evidence of nephrotic syndrome, defined as 24-hour protein > 3.5g with concurrent hypoalbuminemia (Albumin < 3.0 g/dl), within 6 months of Screening
• End-stage renal disease requiring dialysis or transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BHV-1400; 500mg BHV-1400 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.	Drug: BHV-1400; 500 mg delivered subcutaneously via autoinjector
Placebo Comparator: Placebo; Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.	Drug: Placebo; Matching placebo delivered subcutaneously via autoinjector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in GdIgA1 at Week 52		Baseline to Week 52
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52		Baseline to Week 52
Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase		Up to 52 weeks
Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase		Up to 52 weeks
Hematuria resolution at Week 52 (among participants with hematuria at baseline)		Baseline to Week 52
Proportion of study participants reaching a Urinary Protein Excretion (UPE) below 0.5 g/d at Week 52		Baseline to Week 52
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed during the DB Treatment Phase (up to 52 weeks)		Up to 52 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed during the DB Treatment Phase (up to 52 weeks)		Up to 52 Weeks
Change from baseline difference in the magnitude of the treatment effect (BHV-1400 versus placebo) in eGFR at Week 52.	Assessed by the lower limit of the 1-sided 80% confidence interval change from baseline difference	Baseline to Week 52
Number of participants experiencing any of the following during the DB phase: at least 30% reduction relative to baseline in eGFR for at least 30 days, eGFR <15 mL/min/1.73m2 for at least 30 days, chronic dialysis ≥30 days, kidney transplant, death		Up to 52 Weeks
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed through the Open-label Treatment Phase		Up to 104 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed through the Open-label Treatment Phase		Up to 104 Weeks

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: proteinuria; kidney disease; CKD; glomerulonephritis; Nephropathy; Chronic Kidney disease; IgAN; nephritis; renal disease; Glomerular disease; urologic disease; glomerulonephropathy; Iga nephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis, IGA; Proteinuria
• Other Study ID Numbers: BHV1400-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No