Health Trials

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

ConditionGraves' Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmunovant Sciences GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Group 1 Period 1 and 2: IMVT-1402Experimental treatment 1 intervention
Group B: Group 2 Period 1 and 2: IMVT-1402Experimental treatment 1 intervention
Group C: Group 2 Period 1: IMVT-1402 and Period 2: PlaceboExperimental treatment 1 intervention
Group D: Group 3 Period 1 and 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Percentage of participants who are euthyroid and off ATD at Week 52

Time frame
Week 52
2

Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52

Time frame
Week 52
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunovant Sciences GmbH

Lead sponsor

Source ClinicalTrials.gov
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