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
Cary Mariash, MD
Primary Investigator
Brief description of study
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.
Detailed description of study
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.
PRIMARY OUTCOMES:
- 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
SECONDARY OUTCOMES:
- Percentage of participants who are euthyroid and off ATD at Week 52
- Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at 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
- 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
- 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
- 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
- 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
- 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
- Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26
- Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Graves' Disease
-
Age: 18 years - 75 years
-
Gender: All
Inclusion Criteria:
- Have documented diagnosis of GD.
- Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
- Meet one of the following at the Screening Visit:
- Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
- Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
- Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
- Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:
- Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.
- Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
- Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
- Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
- Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.
- Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit.
- Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.
- 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.
