Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Part of paid clinical trials in Glendora, California.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT05517447
Phase
PHASE3
Status
Terminated

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational cohort study — OTHER
    Observational cohort study
  • Batoclimab — DRUG
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Study Details

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.

Key Dates

Start date
Nov 6, 2022
Status verified
Apr 2026
Primary completion
Apr 2, 2026
Completion
Apr 2, 2026

Study Design

Enrollment
109 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Observational cohort
    Proptosis responders in feeder studies will enter in a non-treatment observational study
  • Experimental: Treatment Cohort
    Proptosis 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

Primary Outcome Measure

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

Locations (9)

FacilityCityStateZIPSite coordinators
Site Number - 1520GlendoraCalifornia91741-
Site Number - 1501AuroraColorado80045-
Site Number - 1526LivoniaMichigan48152-
Site Number - 1513RochesterMinnesota55905-
Site Number - 1540Las VegasNevada89184-
Site Number - 1508HoustonTexas77030-
Site Number - 1558MesquiteTexas75149-
Site Number - 1511MorgantownWest Virginia26506-
Site Number - 1518MilwaukeeWisconsin53226-

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