Active Non-anterior, Non-infectious UveitisPhase 2NCT07552012
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
A Phase 2 study testing FXS5626 tablet in people with Active Non-anterior, Non-infectious Uveitis, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Non-anterior, Non-infectious Uveitis
- What is being tested?
- FXS5626 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
EC of the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Yan, +86-23-89011876, cyyy_ll@163.com
About this study
Official title: 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
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.
- Being tested
- FXS5626 tablet, Placebo
- Keywords
- Uveitis, Active, Non-anterior, Non-infectious
- Medical subject headings
- Uveitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXS5626 tabletDrug
Administered twice per day for 24 weeks.
FXS5626 tabletOther
Administered twice per day for 24 weeks.
PlaceboOther
Administered twice per day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Measured: 24 weeks
Secondary outcomes (6)
Time to Treatment Failure from week 6 to week 24.
Measured: 24 weeks
At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.
Measured: 24 weeks
At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.
Measured: 24 weeks
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Measured: 24 weeks
Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.
Measured: 24 weeks
At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start29 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Non-anterior, Non-infectious UveitisStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552012
- Sponsor's protocol ID
- FXS5626-CN-PhⅡ-NIU
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07552012
- Acronym / sponsor ID
- FXS5626-CN-PhⅡ-NIU
- Keywords
- Uveitis, Active, Non-anterior, Non-infectious
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Arm1-FXS5626 50 mg group | Experimental | Drug: FXS5626 tabletParticipants will receive FXS5626 50 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral |
| Arm2-FXS5626 25 mg group | Experimental | Other: FXS5626 tabletParticipants will receive FXS5626 25 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral |
| Arm3-Placebo group | Placebo comparator | Other: PlaceboParticipants will receive placebo twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FXS5626 tabletAdministered twice per day for 24 weeks. | Drug | Arm1-FXS5626 50 mg group |
| FXS5626 tabletAdministered twice per day for 24 weeks. | Other | Arm2-FXS5626 25 mg group |
| PlaceboAdministered twice per day for 24 weeks. | Other | Arm3-Placebo group |
Primary outcome
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Time frame: 24 weeks
6 secondary outcomes
Time to Treatment Failure from week 6 to week 24.
Time frame: 24 weeks
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
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
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.
Time frame: 24 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FXS5626 tablet in people with Active Non-anterior, Non-infectious Uveitis, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang (+86-23-89011876, Peizengyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients meeting treatment failure criteria from week 6 to week 24. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.