Graves' Disease
Conditions
Keywords
IMVT-1402, Graves' disease, Thyroid-Stimulating Hormone Receptor, Immunoglobulin G, Antithyroid drug, Imeroprubart
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.
Interventions
DRUGIMVT-1402
Dose 1 for 26 weeks
DRUGPlacebo
For 26 weeks
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| 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) | Week 26 |
| Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1) | Week 26 |
| Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2) | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2) | Week 26 |
| Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2) | 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) | 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) | 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) | 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) | Baseline, Week 2 |
Countries
Australia, Brazil, Bulgaria, Chile, Czechia, Georgia, Greece, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTCentral Study Contact
Outcome results
None listed