Recruiting NCT06727604

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

Phase II Interventional Graves' Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: IMVT-1402, IMVT-1402, Placebo.
Who it may be relevant to: Registry conditions: Graves' Disease. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Georgia, Germany, Hungary +5
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

Overview

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.

Interventions

Drug IMVT-1402
600 mg SC QW for 52 weeks
Drug IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Drug Placebo
SC QW for 52 weeks

Primary outcome measures

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]

Secondary outcome measures (11)

Percentage of participants who are euthyroid and off ATD at Week 52 [Time frame: Week 52]
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Week 4]
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26 [Time frame: Week 26]
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26 [Time frame: Week 26]
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52 [Time frame: Week 52]

Eligibility criteria

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 GD who are hyperthyroid despite ATD treatment.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment