COMPLETED

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Talk to us

Conditions

Thyroid Eye DiseaseBatoclimabIMVT-1401Monoclonal antibodyAutoimmune disordersGraves' OphthalmopathyGraves' Orbitopathy

Quick Navigation

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:2022-11-23
Study Completion:2025-11-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05517421

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 CriteriaExclusion 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:
  3. * A CAS ≥ 4 in either eye, and
  4. * Clinical evidence of worsened proptosis with:
  5. 1. Proptosis ≥ 18 mm and/or
  6. 2. Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
  7. * Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
  8. * Have onset of active TED within 12 months prior to screening.
  9. * Have documented evidence of detectable anti-TSHR-Ab at screening.
  10. * 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.
  11. * 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 - 1557
Beverly Hills, California, 90210
United States
Site Number - 1539
Carlsbad, California, 92011
United States
Site Number - 1502
Los Angeles, California, 90025
United States
Site Number - 1505
Los Angeles, California, 90033
United States
Site Number - 1532
Los Angeles, California, 90255
United States
Site Number - 1537
San Diego, California, 92108
United States
Site Number - 1531
Torrance, California, 90505
United States
Site Number - 1501
Aurora, Colorado, 80045
United States
Site Number - 1544
Longmont, Colorado, 80503
United States
Site Number - 1547
Newark, Delaware, 19713
United States
Site Number - 1504
Miami, Florida, 33136
United States
Site Number - 1538
Port Charlotte, Florida, 33952
United States
Site Number - 1542
Tampa, Florida, 33603
United States
Site Number - 1536
West Palm Beach, Florida, 33401
United States
Site Number - 1554
Stockbridge, Georgia, 30281
United States
Site Number - 1534
Chicago, Illinois, 60610
United States
Site Number - 1545
Iowa City, Iowa, 52242
United States
Site Number - 1535
Baltimore, Maryland, 21231
United States
Site Number - 1506
Boston, Massachusetts, 02130
United States
Site Number - 1540
Las Vegas, Nevada, 89184
United States
Site Number - 1530
Chapel Hill, North Carolina, 27517
United States
Site Number - 1550
Columbus, Ohio, 43215
United States
Site Number - 1507
Portland, Oregon, 97232
United States
Site Number - 1556
Warwick, Rhode Island, 02886
United States
Site Number - 1551
Dallas, Texas, 75231
United States
Site Number - 1508
Houston, Texas, 77030
United States
Site Number - 1558
Mesquite, Texas, 75149
United States
Site Number - 1500
Roanoke, Virginia, 24018
United States
Site Number - 1509
Madison, Wisconsin, 53705
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 Date2022-11-23
Study Completion Date2025-11-18

Study Record Updates

Study Start Date2022-11-23
Study Completion Date2025-11-18

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