NCT01905124

Safety &Efficacy of CF101 to Subjects With Uveitis

A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Daily CF101 Administered Orally to Subjects With Active, Sight-Threatening, Noninfectious Intermediate or Posterior Uveitis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Can-Fite BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active, sight-threatening, noninfectious intermediate or posterior uveitis.

Detailed description

This is a Phase 2, randomized, double-masked, placebo-controlled study in adult males and females, aged 18 years and over, with active, sight-threatening, noninfectious intermediate or posterior uveitis. Subjects will be randomly assigned to receive CF101 1 mg or matching placebo tablets in a 2:1 ratio orally every 12 hours for 24 weeks. At the Screening Visit (performed within 4 weeks prior to Baseline), subjects who provide written informed consent will have a complete medical history, medication history, physical examination, weight, sitting blood pressure, pulse rate, temperature, electrocardiogram (ECG), clinical laboratory tests, and ophthalmologic examination, including biomicroscopy and grading of uveitis activity. For assessment of uveitis activity and response to treatment, fundus photography will be obtained according to a standardized procedure and interpreted at the Uveitis Photograph Reading Center. Subjects who successfully qualify will begin dosing with CF101 1 mg or placebo, to be taken orally every 12 hours for 24 weeks. At the Baseline Visit, a PBMC sample will be obtained for assessment of A3AR expression level. Subjects will return for safety and efficacy assessments and a new supply of study medication at Weeks 2, 4, 8, 12, 16, 20, and for final assessment and discharge at Week 24. A telephone call to each subject will be made at Week 26, for the purpose of collecting information on adverse events (AEs) and concomitant medications. During the course of the trial, concomitant use of intraocular or posterior subtenon corticosteroids, intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors), systemic corticosteroids at a dose \>20 mg/day prednisone equivalent, or monoclonal antibody therapy is prohibited. Systemic corticosteroid and immunosuppressive regimens must remain stable throughout the course of the trial.

Conditions

• Uveitis, Posterior
• Uveitis, Intermediate

Interventions

Type	Name	Description
DRUG	CF101	CF101 1 mg tablets orally every 12 hours for 24 weeks
DRUG	Placebo	Matching placebo tablets orally every 12 hours for 24 weeks

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-09-01
• Completion: 2019-10-01
• First posted: 2013-07-23
• Last updated: 2018-02-01

Locations

1 site across 1 country: Israel