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RecruitingNCT07547995Updated Jul 24, 2026

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

A Phase 2 interventional study of GenSci048 and Placebo in Uveitis, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Uveitis

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03

In context

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

This study's planned enrollment of 74 is above the median of 30 across 175 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 (ICF), and comply with study requirements and complete the study.

Exclusion criteria

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 macular edema due to diabetic retinopathy;
  3. Subjects with systemic inflammatory diseases requiring continued treatment with oral or prohibited 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;
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    GenSci048 group

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

    Drug: GenSci048

  • Experimental
    Placebo

    Administered SC every 4 weeks.

    Drug: Placebo

Interventions

  • Administered SC.

  • DrugPlacebo

    Administered SC.

06

What researchers measure

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.

    Time frame: 25 weeks

Secondary outcomes

  1. 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)

  2. 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

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

    Time frame: 197 days

Other outcomes

  1. Biomarker and ER analysis

    Time frame: 197 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.

Of 17 phase 2 interventional studies under Uveitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 37. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2026
First posted
Apr 23, 2026
StartActual
Jun 29, 2026
Primary completionEst.
Dec 14, 2027
CompletionEst.
Jan 13, 2028
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07547995
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Jun 29, 2026
Primary completion
Dec 14, 2027 (estimated)
Completion
Jan 13, 2028 (estimated)
Last update
Jul 24, 2026

Study contacts

Jingsi Li
Contact
lijingsi@genscigroup.com
+86 18301941524

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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