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

Phase 2

Recruiting

• Conditions: Graves' Disease
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT06727604
• Lead Sponsor: Immunovant Sciences GmbH

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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-11
• Study Start: 2024-12-17
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Have documented diagnosis of GD.
• Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
• Meet one of the following at the Screening Visit:
• Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
• Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
• Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
• Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:
• Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.
• Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
• Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.

Additional inclusion criteria are defined in the protocol.

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Exclusion Criteria

• Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
• Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.
• Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit.
• Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Period 1 and 2: IMVT-1402	IMVT-1402	-
Group 2 Period 1 and 2: IMVT-1402	IMVT-1402	-
Group 2 Period 1: IMVT-1402 and Period 2: Placebo	IMVT-1402	-
Group 3 Period 1 and 2: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	Week 26

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who are euthyroid and off ATD at Week 52	Week 52
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52	Week 52
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78	Week 78
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104	Week 104
Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52	Week 52
Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78	Week 78
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline	Week 2
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline	Week 4
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26	Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26	Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52	Week 52

Trial Locations

Locations (1)

Site number - 1002; 🇺🇸 Austin, Texas, United States