ACTIVE_NOT_RECRUITING

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Conditions

Thyroid Eye Disease Batoclimab IMVT-1401 Monoclonal antibody Autoimmune disorders Graves' Ophthalmopathy Graves' Orbitopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

Quick Facts

Study Start:2023-01-05

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05524571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Are ≥18 years of age at screening. 2. 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 3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines. 4. Have onset of active TED within 12 months prior to screening. 5. Have documented evidence of detectable anti-TSHR-Ab at screening. 6. 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. 7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.	1. Have decreased best corrected visual acuity due to optic neuropathy. 2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye. 3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening. 4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED. 5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study. 6. Had previous orbital irradiation or surgery for TED.

Inclusion Criteria

Exclusion Criteria

1. Are ≥18 years of age at screening.
2. 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
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. 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.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

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

Contacts and Locations

Study Locations (Sites)

Site Number -1520

Pasadena, California, 91107

United States

Site Number -1517

San Francisco, California, 94143

United States

Site Number -1514

Torrance, California, 90502

United States

Site Number -1510

Sarasota, Florida, 34239

United States

Site Number -1516

Louisville, Kentucky, 40202

United States

Site Number - 1526

Livonia, Michigan, 48152

United States

Site Number - 1513

Rochester, Minnesota, 55905

United States

Site Number - 1512

Winston-Salem, North Carolina, 27157

United States

Site Number - 1525

Portland, Oregon, 97239

United States

Site Number -1515

Bellaire, Texas, 77401

United States

Site Number - 1524

McAllen, Texas, 78503

United States

Site Number -1519

San Antonio, Texas, 78215

United States

Site Number - 1521

Seattle, Washington, 98104

United States

Site Number -1511

Morgantown, West Virginia, 26506

United States

Site Number - 1518

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-05

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-01-05

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Batoclimab
Thyroid eye disease
IMVT-1401
Monoclonal antibody
Autoimmune disorders
Graves' Ophthalmopathy
Graves' Orbitopathy

Additional Relevant MeSH Terms

Thyroid Eye Disease