A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Purpose
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.
Condition
- Graves' Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts 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 exclusion criteria are defined in the protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 Period 1 and 2: IMVT-1402 |
|
|
|
Experimental Group 2 Period 1 and 2: IMVT-1402 |
|
|
|
Experimental Group 2 Period 1: IMVT-1402 and Period 2: Placebo |
|
|
|
Placebo Comparator Group 3 Period 1 and 2: Placebo |
|
Recruiting Locations
Site Number - 1032
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Site Number - 1036
Phoenix 5308655, Arizona 5551752 85015
Phoenix 5308655, Arizona 5551752 85015
Site Number - 1001
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Site Number - 1034
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Site Number - 1035
Santa Clarita 5393049, California 5332921 91321
Santa Clarita 5393049, California 5332921 91321
Site Number - 1005
Torrance 5403022, California 5332921 90502
Torrance 5403022, California 5332921 90502
Site Number - 1013
Englewood 5421250, Colorado 5417618 80113
Englewood 5421250, Colorado 5417618 80113
Site Number - 1010
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Site Number - 1040
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
Site Number - 1029
Clearwater 4151316, Florida 4155751 33756
Clearwater 4151316, Florida 4155751 33756
Site Number - 1028
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Site Number - 1011
Orlando 4167147, Florida 4155751 32819
Orlando 4167147, Florida 4155751 32819
Site Number - 1016
Port Charlotte 4169130, Florida 4155751 33952
Port Charlotte 4169130, Florida 4155751 33952
Site Number - 1012
West Palm Beach 4177887, Florida 4155751 33401
West Palm Beach 4177887, Florida 4155751 33401
Site Number - 1038
Atlanta 4180439, Georgia 4197000 30318
Atlanta 4180439, Georgia 4197000 30318
Site Number - 1020
Stockbridge 4224681, Georgia 4197000 30281
Stockbridge 4224681, Georgia 4197000 30281
Site Number - 1027
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Site Number - 1022
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
Site Number - 1023
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Site Number - 1026
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Site Number - 1018
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48334
Site Number - 1008
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Site Number - 1017
Omaha 5074472, Nebraska 5073708 68105
Omaha 5074472, Nebraska 5073708 68105
Site Number - 1007
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Site Number - 1003
Portland 5746545, Oregon 5744337 97035
Portland 5746545, Oregon 5744337 97035
Site Number - 1033
Philadelphia 4560349, Pennsylvania 6254927 19140
Philadelphia 4560349, Pennsylvania 6254927 19140
Site Number - 1015
Summerville 4597919, South Carolina 4597040 29485
Summerville 4597919, South Carolina 4597040 29485
Site Number - 1042
Chattanooga 4612862, Tennessee 4662168 37421
Chattanooga 4612862, Tennessee 4662168 37421
Site Number - 1002
Austin 4671654, Texas 4736286 78731
Austin 4671654, Texas 4736286 78731
Site Number - 1019
Dallas 4684888, Texas 4736286 75208
Dallas 4684888, Texas 4736286 75208
Site Number - 1031
Dallas 4684888, Texas 4736286 75231
Dallas 4684888, Texas 4736286 75231
Site Number - 1004
Mesquite 4710826, Texas 4736286 75149
Mesquite 4710826, Texas 4736286 75149
Site Number - 1009
Round Rock 4724129, Texas 4736286 78681
Round Rock 4724129, Texas 4736286 78681
Site Number - 1014
San Antonio 4726206, Texas 4736286 78215
San Antonio 4726206, Texas 4736286 78215
Site Number - 1030
Salt Lake City 5780993, Utah 5549030 84108
Salt Lake City 5780993, Utah 5549030 84108
Site Number - 1037
San Juan 4568127, Puerto Rico 00921-3313
San Juan 4568127, Puerto Rico 00921-3313
More Details
- Status
- Recruiting
- Sponsor
- Immunovant Sciences GmbH