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

A Phase II Clinical Study to Assess the Efficacy and Safety of GenSci048 in Subjects With Active Non-infectious Uveitis.

This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.

Study Overview

• Status: Recruiting
• Conditions: Uveitis
• Intervention / Treatment: Drug: Placebo; Drug: GenSci048

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jingsi Li; Phone Number: +86 18301941524; Email: lijingsi@genscigroup.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200031
      • Recruiting
      • EYE & ENT Hospital of Fudan University
      • Contact: Peizeng Yang, Doctor; Phone Number: 023-89012851; Email: Peizengyang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years, regardless of gender;
2. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;
3. Must have active disease at the baseline visit while receiving a stable dose of oral prednisone maintenance therapy for at least 2 weeks;
4. 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;
5. No intention to become pregnant and willingness to use highly effective contraception during the study and for 24 weeks after the last dose of study drug;
6. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.

Exclusion Criteria:

1. Subjects with isolated anterior uveitis;
2. Subjects with neovascular/wet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy;
3. Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baseline visits;

4. Any of the following:

   Confirmed active tuberculosis (TB) infection, including but not limited to radiologically confirmed active TB; Subjects with latent TB infection or at high risk for TB may be enrolled, provided they are not considered unsuitable by the investigator (e.g., unwillingness to continue anti-TB treatment per local guidelines after entering the study);

5. 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;
6. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded) within 12 weeks prior to baseline visit;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Administered SC every 4 weeks.	Drug: Placebo; Administered SC.
Experimental: GenSci048 group; GenSci048 high-dose administered subcutaneously (SC) according to the protocol.	Drug: GenSci048; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	25 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	197 days
Incidence and severity of treatment-emergent adverse events (TEAEs)		197 days

Other Outcome Measures

Outcome Measure	Time Frame
Biomarker and ER analysis	197 days

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): January 13, 2028

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: GenSci048-206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No