Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

Part of paid clinical trials in Burbank, California.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT07661056
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BHV-1300 — DRUG
    delivered subcutaneously via autoinjector
  • Placebo — DRUG
    delivered subcutaneously via autoinjector

Study Details

The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid

Key Dates

First listed
Jun 22, 2026
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: BHV-1300
    BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 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-1300 or placebo.

Primary Outcome Measure

Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26. [ Time Frame: Week 26 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Site-032BurbankCalifornia91501-
Site-062Huntington BeachCalifornia92647-
Site-006San DiegoCalifornia92108-
Site-067Walnut CreekCalifornia94598-
Site-052DoralFlorida33172-
Site-019HialeahFlorida33016-
Site-031ChampaignIllinois61822-
Site-025LenexaKansas66234-
Site-072Las VegasNevada89148-
Site-038AshevilleNorth Carolina28803-
Site-011GreenvilleNorth Carolina27834-
Site-064Morehead CityNorth Carolina28557-
Site-039RaleighNorth Carolina27612-
Site-033StatesvilleNorth Carolina28625-
Site-045WilmingtonNorth Carolina28405-
Site-008CantonOhio44718-
Site-055DallasTexas75231-
Site-043DentonTexas76210-
Site-042El PasoTexas79935-
Site-071HoustonTexas77058-
Site-054McKinneyTexas75069-
Site-013LaytonUtah84041-
Site-073MidlothianVirginia23112-
Site-076SeattleWashington98104-

Related Studies