Recruiting NCT07018323

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, Australia, Brazil, Bulgaria, Chile +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 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.

Interventions

Drug IMVT-1402
Dose 1 for 26 weeks
Drug IMVT-1402
Dose 2 for 26 weeks
Drug Placebo
For 26 weeks

Primary outcome measures

Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) [Time frame: Week 26]

Secondary outcome measures (9)

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) [Time frame: Week 26]
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1) [Time frame: Week 26]
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2) [Time frame: Week 26]
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2) [Time frame: Week 26]
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2) [Time frame: Week 26]
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) [Time frame: Baseline, Week 4]
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) [Time frame: 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 (Dose 2) [Time frame: Baseline, Week 4]
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) [Time frame: Baseline, Week 2]

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

Study locations

United States · 33 centers

Site Number - 1015 — Tucson
Site Number -1014 — Concord
Site Number - 1013 — Aurora
Site Number - 1024 — Doral
Site Number - 1008 — Hialeah
Site Number - 1000 — Miami
Site Number - 1020 — Columbus
Site Number - 1022 — Topeka
… and 25 more centers

Brazil · 14 centers

Site Number - 5511 — Fortaleza
Site Number - 5513 — Belo Horizonte
Site Number - 5500 — Campinas
Site Number - 5505 — Santo André
Site Number - 5502 — Brasília
Site Number - 5503 — Curitiba
Site Number - 5504 — Curitiba
Site Number - 5501 — Porto Alegre
… and 6 more centers

Bulgaria · 14 centers

Site Number - 5610 — Sofia
Site Number - 5613 — Dobrich
Site Number - 5606 — Plovdiv
Site Number - 5607 — Plovdiv
Site Number - 5601 — Sliven
Site Number - 5612 — Smolyan
Site Number - 5604 — Sofia
Site Number - 5609 — Sofia
… and 6 more centers

Israel · 12 centers