Enrolling by invitation NCT07286006

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

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.
Who it may be relevant to: Registry conditions: Graves' Disease. Basic parameters: from 18 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, Bulgaria, Czechia, Latvia +2
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 Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

Overview

This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.

Interventions

Drug IMVT-1402
Dose 1 for up to 52 weeks

Primary outcome measures

Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402 [Time frame: At Week 52]

Secondary outcome measures (12)

Percentage of Group A Participants who are euthyroid and off ATD [Time frame: At Week 26]
Percentage of Group A Participants who are euthyroid and off ATD [Time frame: Up to Week 52]
Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402 [Time frame: Up to Week 52]
Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants [Time frame: Up to Week 52]
Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time frame: Up to Week 52]
Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time frame: At Week 52]
Time from Week 0 to the earliest date of confirmed relapse in Group B Participants [Time frame: Up to Week 52]
Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time frame: Up to Week 52]
Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time frame: At Week 52]
Time From Week 0 to the earliest date of confirmed relapse in Group C Participants [Time frame: Up to Week 52]
Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time frame: At Week 26]
Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time frame: Up to Week 52]

Eligibility criteria

Inclusion criteria

Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
Other, more specific inclusion criteria are defined in the protocol.

Exclusion criteria

Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.

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

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment