Graves' Disease
Conditions
Keywords
IMVT-1402, Anti Thyroid Drug, Hyperthyroidism, Autoimmune thyroid disease, Imeroprubart
Brief summary
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.
Interventions
DRUGIMVT-1402
600 mg SC QW for 52 weeks
DRUGPlacebo
SC QW for 52 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 (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26 | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who are euthyroid and off ATD at Week 52 | Week 52 |
| Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52 | Week 52 |
| 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 | Week 78 |
| 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 | Week 104 |
| Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52 | Week 52 |
| Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78 | Week 78 |
| 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 | 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 | Week 4 |
| Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26 | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26 | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52 | Week 52 |
Countries
Belgium, Georgia, Germany, Hungary, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
Contacts
CONTACTCentral Study Contact
Outcome results
None listed