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: NCT05517421
• Other study ID #: IMVT-1401-3201
• Status: Recruiting
• Phase: Phase 3
• Start date: November 23, 2022
• Est. completion date: January 2025

Study information

• Verified date: June 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:

• 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:

1. Proptosis = 18 mm and/or

2. 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.

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.

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
Canada	Site Number - 2502	Edmonton	Alberta
Canada	Site Number - 2501	Montreal	Quebec
Canada	Site Number - 2500	Ottawa	Ontario
Georgia	Site Number - 3450	Tbilisi
Georgia	Site Number - 3451	Tbilisi
Georgia	Site Number - 3453	Tbilisi
Georgia	Site Number - 3454	Tbilisi
Germany	Site Number - 6608	Frankfurt	Hesse
Germany	Site Number - 6610	Leipzig	Saxony
Germany	Site Number - 6604	Mainz	Rheinland-Pfalz
Germany	Site Number - 6611	Schwerin
Germany	Site Number - 6609	Tuebingen	Baden - Wuttemberg
Israel	Site Number - 4761	Jerusalem
Israel	Site Number - 4763	Nahariya
Israel	Site Number - 4762	Petach Tikva
Israel	Site Number - 4760	Ramat Gan
Italy	Site Number - 6206	Bologna
Italy	Site Number - 6207	Catania
Italy	Site Number - 6203	Milano
Italy	Site Number - 6204	Milano
Italy	Site Number - 6205	Napoli
Italy	Site Number - 6209	Palermo
Italy	Site Number - 6200	Pisa
Italy	Site Number - 6201	Pisa
Italy	Site Number - 6202	Roma
Italy	Site Number - 6208	Rome
Japan	Site Number - 7401	Fukuoka
Japan	Site Number - 7410	Kanagawa
Japan	Site Number - 7402	Kitakyushu
Japan	Site Number - 7405	Kobe
Japan	Site Number - 7407	Nagasaki
Japan	Site Number - 7412	Nankoku
Japan	Site Number - 7404	Tottori
Japan	Site Number - 7413	Yamaguchi
Poland	Site Number - 3103	Katowice
Poland	Site Number - 3101	Kraków
Poland	Site Number - 3102	Lublin
Poland	Site Number - 3104	Lublin
Poland	Site Number - 3105	Lublin
Poland	Site Number - 3106	Olsztyn
Poland	Site Number - 3100	Warsaw
United Kingdom	Site Number - 7305	Guildford
United Kingdom	Site Number - 7310	Hull
United Kingdom	Site Number - 7309	Leicester
United Kingdom	Site Number - 7303	London
United Kingdom	Site Number - 7300	Manchester
United Kingdom	Site Number - 7302	Newcastle Upon Tyne
United Kingdom	Site Number - 7308	Sheffield
United States	Site Number - 1501	Aurora	Colorado
United States	Site Number - 1535	Baltimore	Maryland
United States	Site Number - 1557	Beverly Hills	California
United States	Site Number - 1506	Boston	Massachusetts
United States	Site Number - 1539	Carlsbad	California
United States	Site Number - 1530	Chapel Hill	North Carolina
United States	Site Number - 1534	Chicago	Illinois
United States	Site Number - 1550	Columbus	Ohio
United States	Site Number - 1551	Dallas	Texas
United States	Site Number - 1508	Houston	Texas
United States	Site Number - 1545	Iowa City	Iowa
United States	Site Number - 1540	Las Vegas	Nevada
United States	Site Number - 1544	Longmont	Colorado
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 - 1509	Madison	Wisconsin
United States	Site Number - 1504	Miami	Florida
United States	Site Number - 1547	Newark	Delaware
United States	Site Number - 1507	Portland	Oregon
United States	Site Number - 1500	Roanoke	Virginia
United States	Site Number - 1537	San Diego	California
United States	Site Number - 1554	Stockbridge	Georgia
United States	Site Number - 1542	Tampa	Florida
United States	Site Number - 1531	Torrance	California
United States	Site Number - 1556	Warwick	Rhode Island
United States	Site Number - 1536	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Immunovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Canada,  Georgia,  Germany,  Israel,  Italy,  Japan,  Poland,  United Kingdom, 

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