Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

NCT05517447 — Phase 3, Terminated, 109 participants, Immunovant Sciences GmbH

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An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

RegistryNCT05517447
StatusTerminated - The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.
PhasePhase 3
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment109 (Actual)
SponsorImmunovant Sciences GmbH (Industry)
ConditionsThyroid Eye Disease
InterventionsObservational cohort study, Batoclimab (Other, drug)
Datesstart 2022-11-06, primary completion 2026-04-02, completion 2026-04-02, first posted 2022-08-26, last updated 2026-04-29
Locations55 sites in United States, Australia, Belgium, Georgia, Hungary, Israel, Italy, Latvia and 6 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Thyroid Eye Disease All trials of Observational cohort study All trials of Batoclimab

-Summary

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

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+Arms and interventions

ArmTypeInterventionsDescription
Observational cohortOtherOther: Observational cohort studyProptosis responders in feeder studies will enter in a non-treatment observational study
Treatment CohortExperimentalDrug: BatoclimabProptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks
  • Observational cohort study (Other): Observational cohort study
  • Batoclimab (Drug), also known as IMVT-1401: Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

+Outcome measures

Primary outcomes

  • Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies [Up to Week 24]

Secondary outcomes

  • Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies [At Week 24]
  • Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies [At Week 24]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion criteria:

For all participants:

1\. Have completed the Week 24 visit of the feeder study.

For participants assigned to the Open-label Treatment Cohort:

1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
2. Did not permanently discontinue batoclimab

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

For all participants:

1\. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

+Locations (55)

FacilityCityCountryStatus
Site Number - 1520Glendora, CaliforniaUnited States
Site Number - 1501Aurora, ColoradoUnited States
Site Number - 1526Livonia, MichiganUnited States
Site Number - 1513Rochester, MinnesotaUnited States
Site Number - 1540Las Vegas, NevadaUnited States
Site Number - 1508Houston, TexasUnited States
Site Number - 1558Mesquite, TexasUnited States
Site Number - 1511Morgantown, West VirginiaUnited States
Site Number - 1518Milwaukee, WisconsinUnited States
Site Number - 7565SydneyAustralia
Site Number - 4671BrugesBelgium
Site Number - 4672BrusselsBelgium
Site Number - 4673BrusselsBelgium
Site Number - 4670GhentBelgium
Site Number - 3454TbilisiGeorgia
Site Number - 3455TbilisiGeorgia
Site Number - 3450TbilisiGeorgia
Site Number - 3451TbilisiGeorgia
Site Number - 7550BudapestHungary
Site Number - 7552PécsHungary
Site Number - 4760Ramat Gan, Tel AvivIsrael
Site Number - 4764AfulaIsrael
Site Number - 4761JerusalemIsrael
Site Number - 4762Petah TikvaIsrael
Site Number - 6207CataniaItaly
Site Number - 6204MilanItaly
Site Number - 6203MilanItaly
Site Number - 6205NaplesItaly
Site Number - 6209PalermoItaly
Site Number - 6201PisaItaly
Site Number - 6202RomeItaly
Site Number - 9301OgreLatvia
Site Number - 9300RigaLatvia
Site Number - 9302VentspilsLatvia
Site Number - 7570ChristchurchNew Zealand
Site Number - 3107Gliwice, Silesian VoivodeshipPoland
Site Number - 3101KrakowPoland
Site Number - 3104LublinPoland
Site Number - 3105LublinPoland
Site Number - 1990San JuanPuerto Rico
Site Number - 9200BratislavaSlovakia
Site Number - 9201BratislavaSlovakia
Site Number - 9202TrenčínSlovakia
Site Number - 3602Barcelona, CataloniaSpain
Site Number - 3604MadridSpain
Site Number - 3600Santiago de CompostelaSpain
Site Number - 3606SevilleSpain
Site Number - 3603ValenciaSpain
Site Number - 7305GuildfordUnited Kingdom
Site Number - 7303LondonUnited Kingdom
Site Number - 7312LondonUnited Kingdom
Site Number - 7313LondonUnited Kingdom
Site Number - 7300ManchesterUnited Kingdom
Site Number - 7302Newcastle upon TyneUnited Kingdom
Site Number - 7308SheffieldUnited Kingdom