A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

Sponsor
Immunovant Sciences GmbH
Study ID
NCT05907668
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMVT-1401 (batoclimab) — DRUG
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.

Study Details

The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).

Key Dates

Start date
May 15, 2023
Status verified
Jan 2026
Primary completion
Jul 25, 2025
Completion
Jul 25, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Batoclimab
    Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.

Primary Outcome Measure

Percentage of participants who achieve normalization of free triiodothyronine (FT3) and free thyroxine (FT4), or have FT3 and/or FT4 below the lower limit of normal (LLN) at week 24 without increase in ATD dose [ Time Frame: At Week 24 ]

Related Studies