Clinical trial NCT05524571: 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: 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: 2022-09-01
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:

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.

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: Pasadena
country: United States
facility: Site Number -1520
state: California
city: San Francisco
country: United States
facility: Site Number -1517
state: California
city: Torrance
country: United States
facility: Site Number -1514
state: California
city: Sarasota
country: United States
facility: Site Number -1510
state: Florida
city: Louisville
country: United States
facility: Site Number -1516
state: Kentucky
city: Livonia
country: United States
facility: Site Number - 1526
state: Michigan
city: Rochester
country: United States
facility: Site Number - 1513
state: Minnesota
city: Winston-Salem
country: United States
facility: Site Number - 1512
state: North Carolina
city: Portland
country: United States
facility: Site Number - 1525
state: Oregon
city: Bellaire
country: United States
facility: Site Number -1515
state: Texas
city: McAllen
country: United States
facility: Site Number - 1524
state: Texas
city: San Antonio
country: United States
facility: Site Number -1519
state: Texas
city: Seattle
country: United States
facility: Site Number - 1521
state: Washington
city: Morgantown
country: United States
facility: Site Number -1511
state: West Virginia
city: Milwaukee
country: United States
facility: Site Number - 1518
state: Wisconsin
city: Sydney
country: Australia
facility: Site Number - 7565
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: Ghent
country: Belgium
facility: Site Number -4670
city: Liège
country: Belgium
facility: Site Number - 4674
city: Budapest
country: Hungary
facility: Site Number - 7550
city: Pecs
country: Hungary
facility: Site Number - 7552
city: Pécs
country: Hungary
facility: Site Number - 7551
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: Hamilton
country: New Zealand
facility: Site Number - 7572
city: San Juan
country: Puerto Rico
facility: Site Number -1990
city: Bratislava
country: Slovakia
facility: Site Number - 9203
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
city: Barcelona
country: Spain
facility: Site Number - 3605
city: Madrid
country: Spain
facility: Site Number -3601
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: Adana
country: Turkey
facility: Site Number - 4952
city: Ankara
country: Turkey
facility: Site Number - 4950
city: Istanbul
country: Turkey
facility: Site Number - 4951
Study officials:
References: