Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Thyroid Eye Disease

In brief

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 facts

Study ID

NCT05517421

Run by

Immunovant Sciences GmbH

People needed

114

Starts

2022-11-23

Expected to finish

2025-11-18

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A CAS ≥ 4 in either eye, and
• Clinical evidence of worsened proptosis with:
• Proptosis ≥ 18 mm and/or
• Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
• 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.
• Additional inclusion criteria are defined in the protocol.

You may not qualify if…

• 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.
• Additional exclusion criteria are defined in the protocol.

Where it is running

• Site Number - 7415 — Maebashi, Gunma, Japan
• Site Number- 7418 — Hokkaido, Sapporo, Japan
• Site Number - 7401 — Fukuoka, Japan
• Site Number - 1557 — Beverly Hills, California, United States
• Site Number - 1539 — Carlsbad, California, United States
• Site Number - 1502 — Los Angeles, California, United States
• Site Number - 1505 — Los Angeles, California, United States
• Site Number - 1532 — Los Angeles, California, United States
• Site Number - 1537 — San Diego, California, United States
• Site Number - 1531 — Torrance, California, United States
• Site Number - 1501 — Aurora, Colorado, United States
• Site Number - 1544 — Longmont, Colorado, United States
• Site Number - 1547 — Newark, Delaware, United States
• Site Number - 1504 — Miami, Florida, United States
• Site Number - 1538 — Port Charlotte, Florida, United States
• Site Number - 1542 — Tampa, Florida, United States
• Site Number - 1536 — West Palm Beach, Florida, United States
• Site Number - 1554 — Stockbridge, Georgia, United States
• Site Number - 1534 — Chicago, Illinois, United States
• Site Number - 1545 — Iowa City, Iowa, United States
• Site Number - 1535 — Baltimore, Maryland, United States
• Site Number - 1506 — Boston, Massachusetts, United States
• Site Number - 1540 — Las Vegas, Nevada, United States
• Site Number - 1530 — Chapel Hill, North Carolina, United States
• Site Number - 6208 — Rome, Italy

Full record on ClinicalTrials.gov

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