Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524571
• Other study ID #: IMVT-1401-3202
• Status: Recruiting
• Phase: Phase 3
• Start date: January 5, 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Immunovant Sciences GmbH
• Contact: Central Study Contact
• Phone: 18007970414
• Email: clinicaltrials[@]immunovant.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

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.

Additional exclusion criteria are defined in the protocol.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

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

Locations

Country	Name	City	State
Belgium	Site Number -4671	Brugge
Belgium	Site Number - 4672	Bruxelles
Belgium	Site Number - 4673	Bruxelles
Belgium	Site Number -4670	Ghent
Belgium	Site Number - 4674	Liège
Hungary	Site Number - 7550	Budapest
Hungary	Site Number - 7552	Pecs
Hungary	Site Number - 7551	Pécs
Latvia	Site Number -9301	Ogre
Latvia	Site Number -9300	Riga
Latvia	Site Number - 9302	Ventspils
New Zealand	Site Number - 7570	Christchurch
New Zealand	Site Number - 7572	Hamilton
Puerto Rico	Site Number -1990	San Juan
Slovakia	Site Number - 9200	Bratislava
Slovakia	Site Number - 9201	Bratislava
Slovakia	Site Number - 9203	Bratislava
Slovakia	Site Number - 9202	Trencín
Spain	Site Number - 3605	Barcelona
Spain	Site Number -3602	Barcelona
Spain	Site Number -3601	Madrid
Spain	Site Number -3604	Madrid
Spain	Site Number -3600	Santiago De Compostela
Spain	Site Number -3606	Sevilla
Spain	Site Number -3603	Valencia
Turkey	Site Number - 4952	Adana
Turkey	Site Number - 4950	Ankara
United States	Site Number -1515	Bellaire	Texas
United States	Site Number - 1526	Livonia	Michigan
United States	Site Number -1516	Louisville	Kentucky
United States	Site Number - 1524	McAllen	Texas
United States	Site Number - 1518	Milwaukee	Wisconsin
United States	Site Number -1511	Morgantown	West Virginia
United States	Site Number -1520	Pasadena	California
United States	Site Number - 1525	Portland	Oregon
United States	Site Number - 1513	Rochester	Minnesota
United States	Site Number -1519	San Antonio	Texas
United States	Site Number -1517	San Francisco	California
United States	Site Number -1510	Sarasota	Florida
United States	Site Number - 1521	Seattle	Washington
United States	Site Number -1514	Torrance	California
United States	Site Number - 1512	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Immunovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Belgium,  Hungary,  Latvia,  New Zealand,  Puerto Rico,  Slovakia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of proptosis responders	Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (=) 2 millimeters (mm) reduction in the study eye without deterioration (=2 mm increase) in the fellow eye.	At Week 24
Secondary	Percentage of participants with proptosis =2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (=) 3 from Baseline in the study eye	The CAS measures the classical signs of acute inflammation (pain, redness, and swelling) in TED. The 7-item scale assigns 1 point for the presence of each of the parameters assessed: spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, swelling of caruncle or plica, swelling of eyelids, swelling of conjunctiva (chemosis). The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity. Higher scores indicate worse symptoms.	Baseline and Week 24
Secondary	Percentage of participants with CAS of 0 or 1 in the study eye		At Week 24
Secondary	Mean change from Baseline in CAS in the study eye		Baseline and Week 24
Secondary	Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion		Baseline and Week 24
Secondary	Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia	Diplopia will be assessed based on 3 grades: Grade I - Intermittent diplopia (diplopia in primary position of gaze, when tired or when first awakening), Grade II - Inconstant diplopia (diplopia at extremes of gaze) and Grade III - Constant diplopia (continuous diplopia in primary or reading position). Higher scores indicate worse symptoms.	Baseline and Week 24
Secondary	Mean change from Baseline in proptosis in the study eye		Baseline and Week 24
Secondary	Percentage of participants with =6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score	The GO-QOL is a 16-item self-administered questionnaire designed to assess how GO affects different aspects related to quality of life (visual functioning and psychosocial consequences). The points given to questions 1 to 8 and 9 to 16 are added to obtain 2 raw scores ranging from 8 to 24; one for visual functioning and one for appearance. Higher scores indicate better outcome.	Baseline and Week 24
Secondary	Percentage of participants with =8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye		Baseline and Week 24