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Purpose

This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.

Condition

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

ArmDescriptionAssigned Intervention
Experimental
IMVT-1402 Dose 1
  • Drug: IMVT-1402
    Dose 1 for 26 weeks
Experimental
IMVT-1402 Dose 2
  • Drug: IMVT-1402
    Dose 2 for 26 weeks
Placebo Comparator
Placebo
  • Drug: Placebo
    For 26 weeks

Recruiting Locations

Site Number - 1015
Tucson, Arizona 85710

Site Number -1014
Concord, California 94520

Site Number - 1013
Aurora, Colorado 80045

Site Number - 1024
Doral, Florida 33166

Site Number - 1008
Hialeah, Florida 33016

Site Number - 1000
Miami, Florida 33143

Site Number - 1020
Columbus, Georgia 31904

Site Number - 1022
Topeka, Kansas 66606

Site Number - 1030
Louisville, Kentucky 40202

Site Number - 1033
Jefferson City, Missouri 65109

Site Number - 1004
Kansas City, Missouri 64110

Site Number - 1019
St Louis, Missouri 63110

Site Number - 1012
Reno, Nevada 89511

Site Number - 1032
Long Island City, New York 11106

Site Number - 1027
New Hyde Park, New York 11434

Site Number - 1009
New York, New York 10022

Site Number - 1018
Williamsville, New York 14221

Site Number - 1010
Chapel Hill, North Carolina 27514

Site Number - 1026
Hickory, North Carolina 28601

Site Number - 1001
Morehead City, North Carolina 27577

Site Number - 1034
Raleigh, North Carolina 27612

Site Number - 1007
Oklahoma City, Oklahoma 73134

Site Number - 1017
Memphis, Tennessee 38119

Site Number - 1029
Dallas, Texas 75224

Site Number - 1002
El Paso, Texas 79935

Site Number - 1003
Fort Worth, Texas 76132

Site Number - 1031
Houston, Texas 77030

Site Number - 1028
Houston, Texas 77054

Site Number -1023
Irving, Texas 75031

Site Number - 1021
Irving, Texas 75039

Site Number - 1025
McKinney, Texas 75069

Site Number - 1011
San Antonio, Texas 78231

Site Number - 1016
Norfolk, Virginia 23510

More Details

Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Central Study Contact
18007970414
clinicaltrials@immunovant.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.