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Tests treatment safety and results for Active Non-anterior, Non-infectious Uveitis
Official title A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
ClinicalTrials.gov ID: NCT07552012
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants must be capable of understanding the trial procedures, voluntarily agree to participate, communicate effectively with the investigators...
- 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...
- 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...
You likely can't join 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)...
- 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;
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.