Phase
Condition
Dry Eye Disease
Treatment
Placebo
Batoclimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Are ≥18 years of age at screening.
Have a clinical diagnosis of TED associated with active, moderate to severe TED withthe 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 diagnosisof 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 planningcorrective surgery/irradiation or medical therapy for TED during the course of thestudy.
Are euthyroid with the Baseline disease under control or have mild hypo- orhyperthyroidism.
Additional inclusion criteria are defined in the protocol.
Exclusion
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 betweenscreening and Baseline assessments in either eye.
Have used any steroid (intravenous or oral) for the treatment of TED or otherconditions within 4 weeks prior to screening.
Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1g of methylprednisolone for the treatment of TED.
Have known autoimmune disease other than TED, that, in the opinion of theInvestigator, 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.
Study Design
Connect with a study center
Site Number - 7565
Sydney, 2000
AustraliaActive - Recruiting
Site Number -4671
Brugge, 8000
BelgiumActive - Recruiting
Site Number - 4672
Bruxelles, 1070
BelgiumActive - Recruiting
Site Number - 4673
Bruxelles, 1200
BelgiumActive - Recruiting
Site Number -4670
Ghent, B-9000
BelgiumActive - Recruiting
Site Number - 4674
Liège, 4000
BelgiumActive - Recruiting
Site Number - 7550
Budapest, 1133
HungaryActive - Recruiting
Site Number - 7552
Pecs, 7623
HungaryActive - Recruiting
Site Number - 7551
Pécs, 7621
HungaryActive - Recruiting
Site Number -9301
Ogre, LV-5001
LatviaActive - Recruiting
Site Number -9300
Riga, LV-1006
LatviaActive - Recruiting
Site Number - 9302
Ventspils, LV-3601
LatviaActive - Recruiting
Site Number - 7570
Christchurch, 8013
New ZealandActive - Recruiting
Site Number - 7572
Hamilton, 3204
New ZealandActive - Recruiting
Site Number -1990
San Juan, 00921
Puerto RicoActive - Recruiting
Site Number - 9200
Bratislava, 82606
SlovakiaActive - Recruiting
Site Number - 9201
Bratislava, 85107
SlovakiaActive - Recruiting
Site Number - 9203
Bratislava, 81108
SlovakiaActive - Recruiting
Site Number - 9202
Trenčín, 91101
SlovakiaActive - Recruiting
Site Number - 3605
Barcelona, 08035
SpainActive - Recruiting
Site Number -3602
Barcelona, 08006
SpainActive - Recruiting
Site Number -3601
Madrid, 28007
SpainActive - Recruiting
Site Number -3604
Madrid, 28034
SpainActive - Recruiting
Site Number -3600
Santiago De Compostela, 15706
SpainActive - Recruiting
Site Number -3606
Sevilla, 41009
SpainActive - Recruiting
Site Number -3603
Valencia, 46026
SpainActive - Recruiting
Site Number - 4952
Adana, 13860
TurkeyActive - Recruiting
Site Number - 4950
Ankara, 6100
TurkeyActive - Recruiting
Site Number - 4951
Istanbul, 34010
TurkeyActive - Recruiting
Site Number -1520
Pasadena, California 91107
United StatesCompleted
Site Number -1517
San Francisco, California 94143
United StatesCompleted
Site Number -1514
Torrance, California 90502
United StatesActive - Recruiting
Site Number -1510
Sarasota, Florida 34239
United StatesCompleted
Site Number -1516
Louisville, Kentucky 40202
United StatesActive - Recruiting
Site Number - 1526
Livonia, Michigan 48152
United StatesActive - Recruiting
Site Number - 1513
Rochester, Minnesota 55905
United StatesActive - Recruiting
Site Number - 1512
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Site Number - 1525
Portland, Oregon 97239
United StatesActive - Recruiting
Site Number -1515
Bellaire, Texas 77401
United StatesCompleted
Site Number - 1524
McAllen, Texas 78503
United StatesActive - Recruiting
Site Number -1519
San Antonio, Texas 78215
United StatesActive - Recruiting
Site Number - 1521
Seattle, Washington 98104
United StatesActive - Recruiting
Site Number -1511
Morgantown, West Virginia 26506
United StatesActive - Recruiting
Site Number - 1518
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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