Clinical trial NCT05517421: Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_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: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of proptosis responders
timeFrame: At Week 24
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 24
measure: Percentage of participants with CAS of 0 or 1 in the study eye
timeFrame: At Week 24
measure: Mean change from Baseline in CAS in the study eye
timeFrame: Baseline and Week 24
measure: Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion
timeFrame: Baseline and Week 24
measure: Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia
timeFrame: Baseline and Week 24
measure: Mean change from Baseline in proptosis in the study eye
timeFrame: Baseline and Week 24
measure: Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score
timeFrame: Baseline and Week 24
measure: Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Site Number - 1557
state: California
city: Carlsbad
country: United States
facility: Site Number - 1539
state: California
city: Los Angeles
country: United States
facility: Site Number - 1502
state: California
city: Los Angeles
country: United States
facility: Site Number - 1505
state: California
city: Los Angeles
country: United States
facility: Site Number - 1532
state: California
city: San Diego
country: United States
facility: Site Number - 1537
state: California
city: Torrance
country: United States
facility: Site Number - 1531
state: California
city: Aurora
country: United States
facility: Site Number - 1501
state: Colorado
city: Longmont
country: United States
facility: Site Number - 1544
state: Colorado
city: Newark
country: United States
facility: Site Number - 1547
state: Delaware
city: Miami
country: United States
facility: Site Number - 1504
state: Florida
city: Port Charlotte
country: United States
facility: Site Number - 1538
state: Florida
city: Tampa
country: United States
facility: Site Number - 1542
state: Florida
city: West Palm Beach
country: United States
facility: Site Number - 1536
state: Florida
city: Stockbridge
country: United States
facility: Site Number - 1554
state: Georgia
city: Chicago
country: United States
facility: Site Number - 1534
state: Illinois
city: Iowa City
country: United States
facility: Site Number - 1545
state: Iowa
city: Baltimore
country: United States
facility: Site Number - 1535
state: Maryland
city: Boston
country: United States
facility: Site Number - 1506
state: Massachusetts
city: Las Vegas
country: United States
facility: Site Number - 1540
state: Nevada
city: Chapel Hill
country: United States
facility: Site Number - 1530
state: North Carolina
city: Columbus
country: United States
facility: Site Number - 1550
state: Ohio
city: Portland
country: United States
facility: Site Number - 1507
state: Oregon
city: Warwick
country: United States
facility: Site Number - 1556
state: Rhode Island
city: Dallas
country: United States
facility: Site Number - 1551
state: Texas
city: Houston
country: United States
facility: Site Number - 1508
state: Texas
city: Mesquite
country: United States
facility: Site Number - 1558
state: Texas
city: Roanoke
country: United States
facility: Site Number - 1500
state: Virginia
city: Madison
country: United States
facility: Site Number - 1509
state: Wisconsin
city: Edmonton
country: Canada
facility: Site Number - 2502
state: Alberta
city: Ottawa
country: Canada
facility: Site Number - 2500
state: Ontario
city: Montreal
country: Canada
facility: Site Number - 2501
state: Quebec
city: Tbilisi
country: Georgia
facility: Site Number - 3452
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: Tbilisi
country: Georgia
facility: Site Number - 3453
city: Tuebingen
country: Germany
facility: Site Number - 6609
state: Baden - Wuttemberg
city: Frankfurt
country: Germany
facility: Site Number - 6608
state: Hesse
city: Mainz
country: Germany
facility: Site Number - 6604
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: Site Number - 6610
state: Saxony
city: Schwerin
country: Germany
facility: Site Number - 6611
city: Afula
country: Israel
facility: Site Number - 4764
city: Jerusalem
country: Israel
facility: Site Number - 4761
city: Nahariya
country: Israel
facility: Site Number - 4763
city: Petach Tikva
country: Israel
facility: Site Number - 4762
city: Ramat Gan
country: Israel
facility: Site Number - 4760
city: Bologna
country: Italy
facility: Site Number - 6206
city: Catania
country: Italy
facility: Site Number - 6207
city: Milano
country: Italy
facility: Site Number - 6204
city: Milano
country: Italy
facility: Site Number - 6203
city: Napoli
country: Italy
facility: Site Number - 6205
city: Palermo
country: Italy
facility: Site Number - 6209
city: Pisa
country: Italy
facility: Site Number - 6200
city: Pisa
country: Italy
facility: Site Number - 6201
city: Roma
country: Italy
facility: Site Number - 6202
city: Rome
country: Italy
facility: Site Number - 6208
city: Maebashi
country: Japan
facility: Site Number - 7415
state: Gunma
city: Hokkaido
country: Japan
facility: Site Number- 7418
state: Sapporo
city: Fukuoka
country: Japan
facility: Site Number - 7401
city: Hyōgo
country: Japan
facility: Site Number - 7403
city: Ibaraki
country: Japan
facility: Site Number - 7411
city: Kanagawa
country: Japan
facility: Site Number - 7410
city: Kitakyushu
country: Japan
facility: Site Number - 7402
city: Kobe
country: Japan
facility: Site Number - 7417
city: Kumamoto
country: Japan
facility: Site Number - 7416
city: Miyazaki
country: Japan
facility: Site Number - 7414
city: Nagasaki
country: Japan
facility: Site Number - 7407
city: Nagoya
country: Japan
facility: Site Number - 7406
city: Nankoku
country: Japan
facility: Site Number - 7412
city: Osaka
country: Japan
facility: Site Number - 7408
city: Tokyo
country: Japan
facility: Site Number - 7409
city: Tottori
country: Japan
facility: Site Number - 7404
city: Yamaguchi
country: Japan
facility: Site Number - 7413
city: Gliwice
country: Poland
facility: Site Number - 3107
city: Katowice
country: Poland
facility: Site Number - 3103
city: Kraków
country: Poland
facility: Site Number - 3101
city: Lublin
country: Poland
facility: Site Number - 3104
city: Lublin
country: Poland
facility: Site Number - 3102
city: Lublin
country: Poland
facility: Site Number - 3105
city: Olsztyn
country: Poland
facility: Site Number - 3106
city: Warsaw
country: Poland
facility: Site Number - 3100
city: Guildford
country: United Kingdom
facility: Site Number - 7305
city: Hull
country: United Kingdom
facility: Site Number - 7310
city: Leicester
country: United Kingdom
facility: Site Number - 7309
city: London
country: United Kingdom
facility: Site Number - 7303
city: London
country: United Kingdom
facility: Site Number - 7311
city: London
country: United Kingdom
facility: Site Number - 7312
city: London
country: United Kingdom
facility: Site Number - 7313
city: Manchester
country: United Kingdom
facility: Site Number - 7300
city: Newcastle Upon Tyne
country: United Kingdom
facility: Site Number - 7302
city: Sheffield
country: United Kingdom
facility: Site Number - 7308
Study officials:
References: