A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

NCT07286006
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Enrolling by invitation
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Participants
372
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Lead sponsor
Immunovant Sciences GmbH
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Start date
2026-01-26
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Number of sites
131
clinicaltrials.gov

Summary
This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.
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Short title
A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)
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Official title
A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 2
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Study type
Interventional
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Completion date
2030-03-01
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First posted
2025-12-16
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Registry last updated
2026-09-29
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Primary completion date
2030-03-01
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Start date
2026-01-26
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Participants
372
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Participant count basis
Estimated
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Planned participants
372
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Protocol amendments
1
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Number of sites
131
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Immunovant Sciences GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07286006
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ClinicalTrials.gov ID
NCT07286006
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402

    Timeframe: At Week 52

  1. Percentage of Group A Participants who are euthyroid and off ATD

    Timeframe: At Week 26

  2. Percentage of Group A Participants who are euthyroid and off ATD

    Timeframe: Up to Week 52

  3. Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402

    Timeframe: Up to Week 52

  4. Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants

    Timeframe: Up to Week 52

  5. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Timeframe: Up to Week 52

  6. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Timeframe: At Week 52

  7. Time from Week 0 to the earliest date of confirmed relapse in Group B Participants

    Timeframe: Up to Week 52

  8. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Timeframe: Up to Week 52

  9. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Timeframe: At Week 52

  10. Time From Week 0 to the earliest date of confirmed relapse in Group C Participants

    Timeframe: Up to Week 52

  11. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Timeframe: At Week 26

  12. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Timeframe: Up to Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
  • Other, more specific inclusion criteria are defined in the protocol.

  • Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.
Sources for eligibility
clinicaltrials.gov

  • Site Number - 1561Phoenix, United States
  • Site Number - 1519Phoenix, United States
  • Site Number - 1530Tucson, United States
  • Site Number - 1510Concord, United States
  • Site Number - 1587Huntington Beach, United States
  • Site Number - 1554Los Angeles, United States
  • Site Number - 1588Orange, United States
  • Site Number - 1559San Francisco, United States
  • Site Number - 1558Santa Clarita, United States
  • Site Number - 1552Torrance, United States
  • Site Number - 1533Aurora, United States
  • Site Number -1514Englewood, United States
  • Site Number - 1516Newark, United States
  • Site Number - 1567Washington D.C., United States
  • Site Number - 1556Clearwater, United States
  • Site Number - 1522Doral, United States
  • Site Number - 1523Hialeah, United States
  • Site Number - 1581Jacksonville, United States
  • Site Number - 1582Jacksonville, United States
  • Site Number - 1505Miami, United States
  • Site Number - 1564Miami, United States
  • Site Number - 1591Miami, United States
  • Site Number - 1590Ocoee, United States
  • Site Number - 1508Orlando, United States
  • Site Number - 1507Port Charlotte, United States

And 106 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)