Phase
Condition
Posterior Uveitis
Uveitis
Treatment
Adalimumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female of Chinese descent, with full Chinese parentage.
Diagnosed with active non-infectious intermediate uveitis, posterior uveitis, orpanuveitis defined by the presence of at least 1 of the following in at least oneeye:
Active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesion
≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN]criteria); or
≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria).
Receiving oral prednisone from ≥ 10mg/day to ≤ 60mg/day (or oral corticosteroidsequivalent) for at least two weeks before Screening and remaining on the same dosefrom Screening to Baseline.
Exclusion
Exclusion Criteria:
Participants with the following ocular events:
Isolated anterior uveitis;
Confirmed or suspected infectious uveitis;
Ocular masquerade syndromes, such as ocular lymphoma;
Presumed ocular histoplasmosis syndrome;
Serpiginous choroidopathy;
Scleritis;
Corneal or lens opacity that precludes visualization of the fundus or thatlikely requires cataract surgery during the duration of the trial;
Macular edema as the only sign of uveitis;
Severe VH that precludes visualization of the fundus at the baseline visit;
Intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidenceof glaucomatous optic nerve injury;
Best Corrected Visual Acuity less than 20 letters Early Treatment DiabeticRetinopathy Study (ETDRS) in either eye at the Baseline visit;
Proliferative or severe non-proliferative diabetic retinopathy or clinicallysignificant macular edema due to diabetic retinopathy;
Neovascular/wet age-related macular degeneration;
Abnormality of vitreo-retinal interface (i.e., vitreomacular traction,epiretinal membranes, etc.) with the potential for macular structural damageindependent of the inflammatory process.
Ocular surgery within 90 days prior to the Baseline visit with the exception ofrefractive laser surgery or retinal laser photocoagulation or YAG (neodymium-doped yttrium aluminium garnet) posterior capsulotomy. These threeexceptions are exclusionary within 30 days prior to Baseline.
Previous exposure to anti-a TNF therapy inhibitor or any biologic therapy with apotential therapeutic impact on non-infectious uveitis and discontinued for reasonsother than lack of efficacy or intolerance (e.g., change of insurance) is allowedafter completing the specified wash-out period prior to the Baseline visit.Participants who have had lack of efficacy or intolerance to TNF inhibitors (including Humira and its biosimilars) are not eligible.
Has received glucocorticosteroid implant, Ozurdex® (dexamethasone implant), orintravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time priorto the Baseline visit. For those with previous exposure of anti-VEGF therapy,participants must complete the specified wash-out period prior to the baselinevisit.
Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30days prior to the baseline visit or oral anti-infectives within 14 days prior to theBaseline visit.
Participant has been receiving cyclophosphamide within 30 days and initiated newcyclophosphamide treatment within 30 days prior to the Baseline visit.
Participant treated with any investigational drug within 30 days or 5 half-lives ofthe drug (whichever is longer) prior to the first dose of study drug or is currentlyenrolled in another clinical study.
Participant received any live vaccine with replicating potential within 28 daysprior to the first dose of study drug, or expected need of live vaccination with anylive vaccine with replicating potential during study participation including atleast 70 days after the last dose of study drug. Live vaccines that are incapable ofreplicating (e.g., JYNNEOS monkeypox vaccine or Convidecia or Convidecia AirCOVID-19 vaccines) are permitted.
Participant treated with oral traditional Chinese medicine (described for thetreatment of UV) within 14 day prior to the first dose of study drug.
Study Design
Connect with a study center
Peking University First Hospital /ID# 243055
Beijing, Beijing 100034
ChinaSite Not Available
Shanghai General hospital /ID# 247252
Shanghai, Shanghai 200080
ChinaSite Not Available
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 247251
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
The second affiliated hospital of Zhejiang University school of medicine /ID# 247251
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253
Wenzhou, Zhejiang 325612
ChinaSite Not Available
Beijing Tongren Hospital, CMU /ID# 243054
Beijing, 100730
ChinaSite Not Available
The first affiliated hospital of chongqing medical university /ID# 242971
Chongqing, 400016
ChinaSite Not Available
Tianjin Medical University Eye Hospital /ID# 243056
Tianjin, 300384
ChinaSite Not Available
Xi'an people's hospital/Xi'an fourth hospital /ID# 243371
XI An, 710000
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.