Shelby Research

IMVT-1402 efficacy study for Graves disease (GD)

FORWARD Study for Graves Disease (GD)

NOW ENROLLING

A Study to Investigate the Efficacy, Safety, and Tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

Trial Details

Brief Summary: 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. Mainly 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.

The investigational treatment being examined in the FORWARD program clinical studies, IMVT-1402, is thought to work in a different way than currently available antithyroid drugs. It is designed to target the underlying cause of Graves’ disease.

Condition or disease
Graves’ Disease (GD)

Intervention/treatment
Drug: IMVT -1402
Drug: Placebo

Phase
Phase 2b Study

Inclusion Criteria

  • Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.

  • Male or female participants aged ≥ 18 years.

  • Participants with diagnosis of Graves’ Disease (GD) who are hyperthyroid despite Antithyroid (ATD) drugs (like tapazole) for at least 3 months by the time they begin the study.

  • Have not undergone Radioactive Iodine Therapy or complete thyroidectomy

  • Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria

  • Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.

  • Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.

  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.

  • Additional exclusion criteria are defined in the protocol.

*Other protocol-defined inclusion/exclusion criteria may apply


View Trial on ClinicalTrials.gov website: NCT06727604