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RecruitingNCT07552012Updated Apr 27, 2026

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

A Phase 2 interventional study of FXS5626 tablet and FXS5626 tablet in Active Non-anterior, Non-infectious Uveitis, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of FXS5626 administered twice daily for 24 weeks in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis(NIU).

This study plans to enroll 40 patients with active non-anterior NIU. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly allocated into 3 groups in a 2:1:1 ratio. Participants in groups 1 and 2 will receive different doses of FXS5626. Participants in group 3 will receive placebo.

02

Conditions studied

  • Active Non-anterior, Non-infectious Uveitis

Keywords

  • Uveitis
  • Active
  • Non-anterior
  • Non-infectious
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

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

Study arms

  • Experimental
    Arm1-FXS5626 50 mg group

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

    Other: FXS5626 tablet

  • Experimental
    Arm2-FXS5626 25 mg group

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

    Other: FXS5626 tablet

  • Placebo comparator
    Arm3-Placebo group

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

    Other: Placebo

Interventions

  • OtherFXS5626 tablet

    Administered twice per day for 24 weeks.

  • OtherFXS5626 tablet

    Administered twice per day for 24 weeks.

  • OtherPlacebo

    Administered twice per day for 24 weeks.

05

What researchers measure

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

  6. At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6.

    Time frame: 24 weeks

06

Study locations

1 of 1 sites recruiting
  • EC of the First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07552012
Lead sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
Jan 29, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 27, 2026

Study contacts

Yang
Contact
Peizengyang@126.com
+86-23-89011876
Ye
Contact
155322188@qq.com
+86-23-89011876

Oversight

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

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