A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.
ConditionUveitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
Eligibility criteria
Qualifiers
Age ≥18 years, regardless of gender;
Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;
Must have active disease at the baseline visit;
Must have demonstrated a prior adequate response to oral corticosteroid therapy (equivalent of oral prednisone up to 1 mg/kg/day), as judged by the investigator;
Disqualifiers
Subjects with isolated anterior uveitis;
Subjects with neovascular/wet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy;
Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baselinevisits;
Presence of significant comorbidities, including but not limited to: uncontrolled hypertension (≥200/105 mmHg), congestive heart failure (Stage D), or uncontrolled type 1 or type 2 diabetes (fasting blood glucose >7.0 mmol/L or random blood glucose >11.1 mmol/L); eligibility will be determined at the discretion of the investigator;
Trial design
Treatments tested in this trial
- GenSci048 High-dose
- GenSci048 Low-dose
- Placebo
Treatment groups
111 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov