A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU

NCT07552012 | Recruiting Phase 2

• 1 other identifier: FXS5626-CN-PhⅡ-NIU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the efficacy and safety of oral FXS5626 in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Conditions

Active Non-anterior, Non-infectious Uveitis

Keywords

Uveitis; Active; Non-anterior; Non-infectious

Outcome Measures

Primary Outcomes (1)

• The percentage of patients meeting treatment failure criteria from week 6 to week 24.

  24 weeks

Secondary Outcomes (6)

• Time to Treatment Failure from week 6 to week 24.

  24 weeks

• At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.

  24 weeks

• At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.

  24 weeks

• At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.

  24 weeks

• Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.

  24 weeks

Study Arms (3)

Arm1-FXS5626 50 mg group

EXPERIMENTAL

Participants will receive FXS5626 50 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral

Other: FXS5626 tablet

Arm2-FXS5626 25 mg group

EXPERIMENTAL

Participants will receive FXS5626 25 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral

Other: FXS5626 tablet

Arm3-Placebo group

PLACEBO COMPARATOR

Participants will receive placebo twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral

Other: Placebo

Interventions

FXS5626 tablet OTHER

Administered twice per day for 24 weeks.

Arm1-FXS5626 50 mg group

Placebo OTHER

Administered twice per day for 24 weeks.

Arm3-Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• At screening visit, male or female paticipants aged 18-70 years (inclusive) ;
• 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;
• 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;
• 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):
• \) 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.

You may not qualify if:

• Participants with isolated anterior uveitis;
• Participants with macular edema as the sole clinical manifestation of intermediate uveitis, posterior uveitis, or panuveitis;
• 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);
• Participants with Histoplasmosis Syndrome (HS);
• Participants with ocular masquerade syndrome, including but not limited to the following causes: trauma, lymphoma, ocular malignant tumor, or surgery;
• Participants with serpiginous choroidopathy;
• 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;
• Participants with severe vitreous opacity or other factors that precludes visualization of the fundus in either eye;
• 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.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

EC of the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Uveitis; Motor Activity

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Behavior

Central Study Contacts

Yang

CONTACT

+86-23-89011876; Peizengyang@126.com

Ye

CONTACT

+86-23-89011876; 155322188@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 27, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)