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

NCT07642050 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: BHV1400-301
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

IgA Nephropathy

Keywords

IgAN; Chronic Kidney disease; Nephropathy; proteinuria; glomerulonephropathy; CKD; nephritis; urologic disease; glomerulonephritis; Glomerular disease; Iga nephropathy; renal disease; kidney disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52

  Baseline to Week 52

Secondary Outcomes (12)

• 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

Study Arms (2)

BHV-1400

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

Matching placebo delivered subcutaneously via autoinjector

Placebo

BHV-1400 DRUG

500 mg delivered subcutaneously via autoinjector

BHV-1400

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA; Renal Insufficiency, Chronic; Kidney Diseases; Proteinuria; Nephritis; Urologic Diseases; Glomerulonephritis

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Central Study Contacts

Chief Medical Officer

CONTACT

203-404-0410; clinicaltrials@biohavenpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06