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

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT07642050
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BHV-1400 — DRUG
    500 mg delivered subcutaneously via autoinjector
  • Placebo — DRUG
    Matching placebo delivered subcutaneously via autoinjector

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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