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 - 1036
Phoenix, Arizona 85015
Phoenix, Arizona 85015
Site Number - 1061
Huntington Beach, California 92647
Huntington Beach, California 92647
Site Number - 1001
Los Angeles, California 90033
Los Angeles, California 90033
Site Number - 1047
Los Angeles, California 90095
Los Angeles, California 90095
Site Number - 1062
Orange, California 92868
Orange, California 92868
Site Number - 1046
Sacramento, California 95816
Sacramento, California 95816
Site Number - 1034
San Francisco, California 94143
San Francisco, California 94143
Site Number - 1005
Torrance, California 90502
Torrance, California 90502
Site Number - 1013
Englewood, Colorado 80113
Englewood, Colorado 80113
Site Number - 1010
Newark, Delaware 19713
Newark, Delaware 19713
Site Number - 1040
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Site Number - 1029
Clearwater, Florida 33756
Clearwater, Florida 33756
Site Number - 1055
Jacksonville, Florida 32204-1177
Jacksonville, Florida 32204-1177
Site Number - 1056
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Site Number - 1028
Miami, Florida 33136
Miami, Florida 33136
Site Number - 1065
Miami, Florida 33186
Miami, Florida 33186
Site Number - 1064
Ocoee, Florida 34761
Ocoee, Florida 34761
Site Number - 1011
Orlando, Florida 32819
Orlando, Florida 32819
Site Number - 1016
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
Site Number - 1012
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Site Number - 1038
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Site Number - 1053
Macon, Georgia 31210
Macon, Georgia 31210
Site Number - 1020
Stockbridge, Georgia 30281
Stockbridge, Georgia 30281
Site Number - 1027
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Site Number - 1041
Kansas City, Kansas 66210
Kansas City, Kansas 66210
Site Number - 1045
Bowling Green, Kentucky 42101
Bowling Green, Kentucky 42101
Site Number - 1054
Florence, Kentucky 41042
Florence, Kentucky 41042
Site Number - 1063
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Site Number - 1022
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Site Number - 1048
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Site Number - 1023
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Site Number - 1026
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Site Number - 1018
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Site Number - 1069
Flint, Michigan 48532
Flint, Michigan 48532
Site Number - 1008
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Site Number - 1068
Gulfport, Mississippi 39501
Gulfport, Mississippi 39501
Site Number - 1017
Omaha, Nebraska 68105
Omaha, Nebraska 68105
Site Number - 1007
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Site Number - 1050
Monroe, New York 10950
Monroe, New York 10950
Site Number - 1051
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Site Number - 1060
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Site Number - 1057
Canton, Ohio 44718
Canton, Ohio 44718
Site Number - 1003
Portland, Oregon 97035
Portland, Oregon 97035
Site Number - 1043
Pottstown, Pennsylvania 19464
Pottstown, Pennsylvania 19464
Site Number - 1015
Summerville, South Carolina 29485
Summerville, South Carolina 29485
Site Number - 1042
Chattanooga, Tennessee 37421
Chattanooga, Tennessee 37421
Site Number - 1066
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Site Number - 1049
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Site Number - 1002
Austin, Texas 78731
Austin, Texas 78731
Site Number - 1067
Bellaire, Texas 77401
Bellaire, Texas 77401
Site Number - 1019
Dallas, Texas 75208
Dallas, Texas 75208
Site Number - 1071
Houston, Texas 77089
Houston, Texas 77089
Site Number - 1004
Mesquite, Texas 75149
Mesquite, Texas 75149
Site Number - 1009
Round Rock, Texas 78681
Round Rock, Texas 78681
Site Number - 1014
San Antonio, Texas 78215
San Antonio, Texas 78215
Site Number - 1052
San Antonio, Texas 78240
San Antonio, Texas 78240
Site Number - 1030
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
Site Number - 1070
Sandy City, Utah 84093
Sandy City, Utah 84093
Site Number - 1058
San Juan, Puerto Rico 00907
San Juan, Puerto Rico 00907
More Details
- Status
- Recruiting
- Sponsor
- Immunovant Sciences GmbH