CompletedPhase 3

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

United States86 participantsStarted 2023-01-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Are ≥18 years of age at screening.
✓. Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:
✓. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
✓. Have onset of active TED within 12 months prior to screening.
✓. Have documented evidence of detectable anti-TSHR-Ab at screening.
✓. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
✓. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

Exclusion criteria

✕. Have decreased best corrected visual acuity due to optic neuropathy.
✕. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
✕. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
✕. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
✕. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
✕. Had previous orbital irradiation or surgery for TED.

What they're measuring

Percentage of proptosis responders

Timeframe: At Week 24

Trial details

NCT IDNCT05524571

SponsorImmunovant Sciences GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-03

View on ClinicalTrials.gov More Thyroid Eye Disease trials