Clinical trial NCT05517447: Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
Official title: An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Eye Disease
Keywords: Batoclimab
Thyroid eye disease
IMVT-1401
Monoclonal antibody
Autoimmune disorders
Graves' Ophthalmopathy
Graves' Orbitopathy
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.


Eligibility criteria: Inclusion criteria:

For all participants:

1. Have completed the Week 24 visit of the feeder study.

For participants assigned to the Open-label Treatment Cohort:

1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
2. Did not permanently discontinue batoclimab

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

For all participants:

1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Primary outcomes:
measure: Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
timeFrame: At Week 24
measure: Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
timeFrame: At Week 24
Other outcomes:
Locations:
city: Glendora
country: United States
facility: Site Number - 1520
state: California
city: Aurora
country: United States
facility: Site Number - 1501
state: Colorado
city: Livonia
country: United States
facility: Site Number - 1526
state: Michigan
city: Rochester
country: United States
facility: Site Number - 1513
state: Minnesota
city: Las Vegas
country: United States
facility: Site Number - 1540
state: Nevada
city: Houston
country: United States
facility: Site Number - 1508
state: Texas
city: Morgantown
country: United States
facility: Site Number - 1511
state: West Virginia
city: Milwaukee
country: United States
facility: Site Number - 1518
state: Wisconsin
city: Brugge
country: Belgium
facility: Site Number - 4671
city: Bruxelles
country: Belgium
facility: Site Number - 4672
city: Bruxelles
country: Belgium
facility: Site Number - 4673
city: Gent
country: Belgium
facility: Site Number - 4670
city: Tbilisi
country: Georgia
facility: Site Number - 3454
city: Tbilisi
country: Georgia
facility: Site Number - 3455
city: Tbilisi
country: Georgia
facility: Site Number - 3450
city: Tbilisi
country: Georgia
facility: Site Number - 3451
city: Budapest
country: Hungary
facility: Site Number - 7550
city: Pécs
country: Hungary
facility: Site Number - 7552
city: Ramat Gan
country: Israel
facility: Site Number - 4760
state: Tel Aviv
city: Afula
country: Israel
facility: Site Number - 4764
city: Jerusalem
country: Israel
facility: Site Number - 4761
city: Petah tikva
country: Israel
facility: Site Number - 4762
city: Napoli
country: Italy
facility: Site Number - 6205
city: Rome
country: Italy
facility: Site Number - 6202
city: Ogre
country: Latvia
facility: Site Number - 9301
city: Riga
country: Latvia
facility: Site Number - 9300
city: Ventspils
country: Latvia
facility: Site Number - 9302
city: Christchurch
country: New Zealand
facility: Site Number - 7570
city: Kraków
country: Poland
facility: Site Number - 3101
city: Lublin
country: Poland
facility: Site Number - 3104
city: Lublin
country: Poland
facility: Site Number - 3105
city: San Juan
country: Puerto Rico
facility: Site Number - 1990
city: Bratislava
country: Slovakia
facility: Site Number - 9200
city: Bratislava
country: Slovakia
facility: Site Number - 9201
city: Trenčín
country: Slovakia
facility: Site Number - 9202
city: Barcelona
country: Spain
facility: Site Number - 3602
state: Catalonia
city: Madrid
country: Spain
facility: Site Number - 3604
city: Santiago De Compostela
country: Spain
facility: Site Number - 3600
city: Sevilla
country: Spain
facility: Site Number - 3606
city: Valencia
country: Spain
facility: Site Number - 3603
city: Guildford
country: United Kingdom
facility: Site Number - 7305
city: London
country: United Kingdom
facility: Site Number - 7303
city: London
country: United Kingdom
facility: Site Number - 7312
city: Sheffield
country: United Kingdom
facility: Site Number - 7308
Study officials:
References: