Clinical trial NCT06727604: A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Graves' Disease
Keywords: IMVT-1402
Anti Thyroid Drug
Hyperthyroidism
Autoimmune thyroid disease
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 of ≥ 20 mg/day 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.

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.

Additional exclusion criteria are defined in the protocol.

Primary outcomes:
measure: 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
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of participants who are euthyroid and off ATD at Week 52
timeFrame: Week 52
measure: Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
timeFrame: Week 52
measure: 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
timeFrame: Week 78
measure: 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
timeFrame: Week 104
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 78
measure: 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
timeFrame: Week 2
measure: 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
timeFrame: Week 4
measure: Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
timeFrame: Week 26
measure: Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26
timeFrame: Week 26
measure: Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Number - 1036
state: Arizona
city: Los Angeles
country: United States
facility: Site Number - 1001
state: California
city: Santa Clarita
country: United States
facility: Site Number - 1035
state: California
city: Torrance
country: United States
facility: Site Number - 1005
state: California
city: Walnut Creek
country: United States
facility: Site Number - 1006
state: California
city: Englewood
country: United States
facility: Site Number - 1013
state: Colorado
city: Clearwater
country: United States
facility: Site Number - 1029
state: Florida
city: Orlando
country: United States
facility: Site Number - 1011
state: Florida
city: Port Charlotte
country: United States
facility: Site Number - 1016
state: Florida
city: West Palm Beach
country: United States
facility: Site Number - 1012
state: Florida
city: Stockbridge
country: United States
facility: Site Number - 1020
state: Georgia
city: New Orleans
country: United States
facility: Site Number - 1022
state: Louisiana
city: Boston
country: United States
facility: Site Number - 1026
state: Massachusetts
city: Farmington Hills
country: United States
facility: Site Number - 1018
state: Michigan
city: Rochester
country: United States
facility: Site Number - 1008
state: Minnesota
city: Omaha
country: United States
facility: Site Number - 1017
state: Nebraska
city: Las Vegas
country: United States
facility: Site Number - 1007
state: Nevada
city: Portland
country: United States
facility: Site Number - 1003
state: Oregon
city: Summerville
country: United States
facility: Site Number - 1015
state: South Carolina
city: Austin
country: United States
facility: Site Number - 1002
state: Texas
city: Dallas
country: United States
facility: Site Number - 1019
state: Texas
city: Dallas
country: United States
facility: Site Number - 1031
state: Texas
city: Houston
country: United States
facility: Site Number - 1025
state: Texas
city: Mesquite
country: United States
facility: Site Number - 1004
state: Texas
city: Round Rock
country: United States
facility: Site Number - 1009
state: Texas
city: San Antonio
country: United States
facility: Site Number - 1014
state: Texas
Study officials:
References: