Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT05517421
Phase
PHASE3
Status
Completed

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

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

Interventions

  • Batoclimab — DRUG
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
  • Placebo — DRUG
    Matching Placebo

Study Details

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Key Dates

Start date
Nov 23, 2022
Status verified
Dec 2025
Primary completion
Nov 2, 2025
Completion
Nov 18, 2025

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Batoclimab
    Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will be administered matching placebo SC weekly for 24 weeks.

Primary Outcome Measure

Percentage of proptosis responders [ Time Frame: At Week 24 ]

Locations (29)

FacilityCityStateZIPSite coordinators
Site Number - 1557Beverly HillsCalifornia90210-
Site Number - 1539CarlsbadCalifornia92011-
Site Number - 1502Los AngelesCalifornia90025-
Site Number - 1505Los AngelesCalifornia90033-
Site Number - 1532Los AngelesCalifornia90255-
Site Number - 1537San DiegoCalifornia92108-
Site Number - 1531TorranceCalifornia90505-
Site Number - 1501AuroraColorado80045-
Site Number - 1544LongmontColorado80503-
Site Number - 1547NewarkDelaware19713-
Site Number - 1504MiamiFlorida33136-
Site Number - 1538Port CharlotteFlorida33952-
Site Number - 1542TampaFlorida33603-
Site Number - 1536West Palm BeachFlorida33401-
Site Number - 1554StockbridgeGeorgia30281-
Site Number - 1534ChicagoIllinois60610-
Site Number - 1545Iowa CityIowa52242-
Site Number - 1535BaltimoreMaryland21231-
Site Number - 1506BostonMassachusetts02130-
Site Number - 1540Las VegasNevada89184-
Site Number - 1530Chapel HillNorth Carolina27517-
Site Number - 1550ColumbusOhio43215-
Site Number - 1507PortlandOregon97232-
Site Number - 1556WarwickRhode Island02886-
Site Number - 1551DallasTexas75231-
Site Number - 1508HoustonTexas77030-
Site Number - 1558MesquiteTexas75149-
Site Number - 1500RoanokeVirginia24018-
Site Number - 1509MadisonWisconsin53705-

Related coverage on Hipa.ai

Find similar trials in Beverly Hills, CA

By research site
Site Number - 1557· Beverly Hills, CASite Number - 1539· Carlsbad, CASite Number - 1502· Los Angeles, CASite Number - 1505· Los Angeles, CASite Number - 1532· Los Angeles, CASite Number - 1537· San Diego, CA

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