A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Conditions

• Graves' Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• IMVT-1402 — DRUG
  600 mg SC QW for 52 weeks
• IMVT-1402 — DRUG
  600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
• Placebo — DRUG
  SC QW for 52 weeks

Study Details

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Key Dates

Start date

Dec 17, 2024

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 Period 1 and 2: IMVT-1402
• Experimental: Group 2 Period 1 and 2: IMVT-1402
• Experimental: Group 2 Period 1: IMVT-1402 and Period 2: Placebo
• Placebo Comparator: Group 3 Period 1 and 2: Placebo

Primary Outcome Measure

Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26 [ Time Frame: Week 26 ]

Central Contacts

• Central Study Contact
  18007970414
  [email protected]

Locations (64)

Find similar trials in Phoenix, AZ

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