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
Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Site Number - 1032
RECRUITING
Phoenix
Site Number - 1036
RECRUITING
Phoenix
California
Site Number - 1001
RECRUITING
Los Angeles
Site Number - 1034
RECRUITING
San Francisco
Site Number - 1035
RECRUITING
Santa Clarita
Site Number - 1005
RECRUITING
Torrance
Site Number - 1006
WITHDRAWN
Walnut Creek
Colorado
Site Number - 1013
RECRUITING
Englewood
Delaware
Site Number - 1010
RECRUITING
Newark
Florida
Site Number - 1029
RECRUITING
Clearwater
Site Number - 1028
RECRUITING
Miami
Site Number - 1011
RECRUITING
Orlando
Site Number - 1016
RECRUITING
Port Charlotte
Site Number - 1012
RECRUITING
West Palm Beach
Georgia
Site Number - 1020
RECRUITING
Stockbridge
Indiana
Site Number - 1027
RECRUITING
Indianapolis
Louisiana
Site Number - 1022
RECRUITING
New Orleans
Massachusetts
Site Number - 1026
RECRUITING
Boston
Maryland
Site Number - 1023
RECRUITING
Baltimore
Michigan
Site Number - 1018
RECRUITING
Farmington Hills
Minnesota
Site Number - 1008
RECRUITING
Rochester
Nebraska
Site Number - 1017
RECRUITING
Omaha
Nevada
Site Number - 1007
RECRUITING
Las Vegas
Oregon
Site Number - 1003
RECRUITING
Portland
Pennsylvania
Site Number - 1033
RECRUITING
Philadelphia
South Carolina
Site Number - 1015
RECRUITING
Summerville
Texas
Site Number - 1002
RECRUITING
Austin
Site Number - 1019
RECRUITING
Dallas
Site Number - 1031
RECRUITING
Dallas
Site Number - 1025
WITHDRAWN
Houston
Site Number - 1004
RECRUITING
Mesquite
Site Number - 1009
RECRUITING
Round Rock
Site Number - 1014
RECRUITING
San Antonio
Utah
Site Number - 1030
RECRUITING
Salt Lake City
Other Locations
Belgium
Site Number - 5303
RECRUITING
Antwerp
Site Number - 5301
RECRUITING
Bruges
Georgia
Site Number - 8002
RECRUITING
Batumi
Site Number - 8007
RECRUITING
Batumi
Site Number - 8006
RECRUITING
Kutaisi
Site Number - 8008
RECRUITING
Marneuli
Site Number - 8001
RECRUITING
Tbilisi
Site Number - 8003
RECRUITING
Tbilisi
Site Number - 8004
RECRUITING
Tbilisi
Site Number - 8005
RECRUITING
Tbilisi
Site Number - 8009
RECRUITING
Tbilisi
Site Number - 8010
RECRUITING
Tbilisi
Site Number - 8011
RECRUITING
Tbilisi
Germany
Site Number - 6505
RECRUITING
Dresden
Site Number - 6502
RECRUITING
Schwerin
Hungary
Site Number - 7554
RECRUITING
Budapest
Site Number - 7556
RECRUITING
Budapest
Site Number - 7551
RECRUITING
Pécs
Site Number - 7552
RECRUITING
Szeged
Italy
Site Number - 6004
RECRUITING
Bologna
Site Number - 6012
RECRUITING
Cagliari
Site Number - 6007
RECRUITING
Milan
Site Number - 6010
RECRUITING
Napoli
Poland
Site Number - 3002
RECRUITING
Krakow
Site Number -3003
RECRUITING
Krakow
Site Number - 3004
RECRUITING
Lublin
Site Number - 3005
RECRUITING
Lublin
Site Number - 3001
RECRUITING
Warsaw
Puerto Rico
Site Number - 1037
RECRUITING
San Juan
Spain
Site Number - 7104
RECRUITING
Badalona
Site Number - 7103
RECRUITING
Barcelona
Site Number - 7102
RECRUITING
Córdoba
Site Number - 7105
RECRUITING
Madrid
Site Number - 7101
RECRUITING
Seville
United Kingdom
Site Number - 7002
RECRUITING
Cardiff
Site Number - 7005
RECRUITING
Huddersfield
Site Number - 7004
RECRUITING
Hull
Site Number - 7003
RECRUITING
London
Site Number - 7007
RECRUITING
London
Site Number - 7006
RECRUITING
Manchester
Site Number - 7001
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date:2024-12-17
Estimated Completion Date:2028-06
Participants
Target number of participants:240
Treatments
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