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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Arm3-Placebo group | Placebo Comparator | Participants will receive placebo twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FXS5626 tablet | Other | Administered twice per day for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients meeting treatment failure criteria from week 6 to week 24. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang | Contact | +86-23-89011876 | Peizengyang@126.com | |
| Ye | Contact | +86-23-89011876 | 155322188@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EC of the First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D001519 | Behavior |
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Parallel Assignment
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| FXS5626 tablet |
| Other |
Administered twice per day for 24 weeks. |
|
| Placebo | Other | Administered twice per day for 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 |
| At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6. | 24 weeks |