Safety &Efficacy of CF101 to Subjects With Uveitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Severity of uveitis on standardized photographic assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Standardized fundus photographs will be obtained and uniformly assessed in a masked fashion at the Reading Center
- Safety of CF101 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Frequency, nature, and severity of adverse events
|Study Start Date:||January 2017|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Drug: CF101
CF101 1 mg q12 hours
CF101 1 mg tablets orally every 12 hours for 24 weeks
Other Name: IB-MECA
Placebo Comparator: Placebo tablets of CF101
Placebo tablets q12 hours
Matching placebo tablets orally every 12 hours for 24 weeks
Other Name: Sugar pills
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905124
|Contact: Sari Fishman, Dr.||email@example.com|
|Bnei-Zion Medical Center||Not yet recruiting|
|Haifa, Israel, 31048|
|Contact: Hanna J Garzozi, Prof. 972-4-8359554 firstname.lastname@example.org|