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

NCT07547995 | Not Yet Recruiting Phase 2

• 1 other identifier: GenSci048-206
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The effectiveness of GenSci048 administered by subcutaneous injection

  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

  197 days

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

  197 days

Other Outcomes (1)

• Biomarker and ER analysis

  197 days

Study Arms (3)

GenSci048 High-dose group

EXPERIMENTAL

GenSci048 high-dose administered subcutaneously (SC) according to the protocol.

Drug: GenSci048 High-dose

GenSci048 Low-dose group

EXPERIMENTAL

GenSci048 low-dose administered subcutaneously (SC) according to the protocol.

Drug: GenSci048 Low-dose

Placebo

EXPERIMENTAL

Administered SC every 4 weeks.

Drug: Placebo

Interventions

GenSci048 High-dose DRUG

High-dose Administered SC.

GenSci048 High-dose group

GenSci048 Low-dose DRUG

Low-dose Administered SC.

GenSci048 Low-dose group

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.

You may not qualify if:

• 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;
• 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);
• 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;
• Subject has previous exposure toanti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded);

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Central Study Contacts

Jingsi Li

CONTACT

+86 18301941524; lijingsi@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): January 13, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

CN (1)