Clinical trial NCT07018323: A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Graves' Disease
Keywords: IMVT-1402
Graves' disease
Thyroid-Stimulating Hormone Receptor
Immunoglobulin G
Antithyroid drug
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.


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 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.

Primary outcomes:
measure: Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
timeFrame: Week 26
measure: Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
timeFrame: Week 26
measure: Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
timeFrame: Week 26
measure: Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)
timeFrame: Week 26
measure: Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
timeFrame: Week 26
measure: 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 (Dose 1)
timeFrame: Baseline, Week 4
measure: 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 (Dose 1)
timeFrame: Baseline, Week 2
measure: 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 (Dose 2)
timeFrame: Baseline, Week 4
measure: 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 (Dose 2)
timeFrame: Baseline, Week 2
Other outcomes:
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