Oral FXS5626 for active non-anterior non-infectious uveitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of FXS5626 Tablets in Patients With Active Non-infectious Uveitis

This 24-week treatment will test whether taking oral FXS5626 twice daily helps adults with active non-anterior non-infectious uveitis and is safe for them.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07552012 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study in China enrolling about 40 adults with active intermediate, posterior, or panuveitis. Participants are randomized 2:1:1 to one of two FXS5626 dose levels or placebo and receive treatment twice daily for 24 weeks. The protocol includes safety monitoring, measurement of uveitis activity, and collection of pharmacokinetic and pharmacodynamic data. Efficacy endpoints focus on change in ocular inflammation while tolerability and adverse events are tracked throughout the study.

Who should consider this trial

Good fit: Adults aged 18–70 with active intermediate, posterior, or pan non-infectious uveitis who meet weight and BMI requirements and can comply with study procedures are the intended participants.

Not a fit: Patients with infectious uveitis, anterior-only uveitis, or those who cannot meet the screening stability criteria or required corticosteroid background therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, FXS5626 could reduce eye inflammation and lower the need for high-dose corticosteroids in people with active non-anterior NIU.

How similar studies have performed: Oral and systemic immunomodulatory therapies have shown benefit in NIU in prior studies, but FXS5626 is a new molecule being specifically tested for efficacy, safety, PK, and PD in this population.

Eligibility criteria

Inclusion Criteria:

1. Participants must be capable of understanding the trial procedures, voluntarily agree to participate, communicate effectively with the investigators, comply with all study requirements throughout the trial, and provide written Informed consent Form (ICF);
2. At screening visit, male or female paticipants aged 18-70 years (inclusive) ;
3. At screening visit, Body mass index (BMI) between 18 and 30 kg/m² (inclusive), with a body weight of ≥50 kg for males and ≥45 kg for females;
4. At screening, at least one eye was diagnosed with active non-infectious uveitis by the investigator, including non-infectious intermediate uveitis, posterior uveitis, or panuveitis;
5. Subject must have active disease at the screening and baseline visit, as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent):

1\) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria) 3) ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria) ; \[6\] Participants and their partners must have no plans for reproduction, sperm donation, or egg donation from the start of treatment until at least one month after the last dose of the investigational drug, and must voluntarily employ an effective method of contraception as determined by the investigator.

Exclusion Criteria:

1. Participants with isolated anterior uveitis;
2. Participants with macular edema as the sole clinical manifestation of intermediate uveitis, posterior uveitis, or panuveitis;
3. Participants with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to Tuberculosis (TB), cytomegalovirus (CMV), Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease and herpes simplex virus (HSV);
4. Participants with Histoplasmosis Syndrome (HS);
5. Participants with ocular masquerade syndrome, including but not limited to the following causes: trauma, lymphoma, ocular malignant tumor, or surgery;
6. Participants with serpiginous choroidopathy;
7. Participants with corneal or lens opacity that precludes visualization of the fundus in either eye or that likely requires cataract surgery during the duration of the trial;
8. Participants with severe vitreous opacity or other factors that precludes visualization of the fundus in either eye;
9. Participant with uncontrolled glaucoma, intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury; The sponsor provides the definitive and complete eligibility criteria in the study protocol.

Where this trial is running

Chongqing, Chongqing Municipality

• EC of the First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yang

Conditions Active Non-anterior, Non-infectious Uveitis; Uveitis; Active; Non-anterior; Non-infectious