A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.

ConditionUveitis

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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 while receiving a stable dose of oral prednisone maintenance therapy for at least 2 weeks;

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 baseline visits;

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

Design model

Parallel

Treatments tested in this trial

GenSci048
Drug
Administered SC.
Placebo
Drug
Administered SC.

Treatment groups

74 Participants

are divided into 2 treatment groups

Group A: GenSci048 groupExperimental treatment 1 intervention

Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The effectiveness of GenSci048 administered by subcutaneous injection

Calculate the proportion of subjects with treatment failure at Week 25 for each GenSci048 dose group and the placebo group, respectively. A superiority test (α=0.05, two-tailed) for the proportion of subjects with treatment failure at Week 25 between each GenSci048 dose group and the placebo group is performed using the stratified Cochran-Mantel-Haenszel (CMH) method.

Time frame

25 weeks

Secondary outcomes

The effectiveness of GenSci048 administered by subcutaneous injection

The change of different ophthalmic parameters at weeks 5, 9, 13, 17, 21, and 25 to baseline and best state achieved prior to week 5(inclusive).

Time frame

From Baseline until end of study/early termination visit (up to 29 weeks)

The Pharmacokinetic (PK) characteristics and immunogenicity of GenSci048 administered by subcutaneous injection

PK; Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) (if applicable).

Time frame

197 days

Incidence and severity of treatment-emergent adverse events (TEAEs)

Time frame

197 days

Other outcomes

Biomarker and ER analysis

Time frame

197 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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