PL8177 Oral Colon Delivery
A Phase 2a, Double-Blind, Randomized Adaptive Design, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Biomarkers with Oral Colon Delivery PL8177 in Adult Subjects with Active Ulcerative Colitis (UC)
Clinical Trial Information
Trial Contact: Garcia de Djuro, Ginette; Shepherd, Adriane R
Trial Phone: 321.841.6649 ; 321 841-2285
IRB No: S22.096.04
Protocol Abbrev: PL8177-205
Principal Investigator: Udayakumar Navaneethan, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: PL8177-205
Treatment: Oral PL8177
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05466890
Primary safety objective:
• To evaluate the safety and tolerability of PL8177 compared to placebo in subjects with active UC.
Primary efficacy objective:
• To demonstrate the efficacy of PL8177 compared to placebo on mucosal healing (a MES of ≤ 1 point (0 or 1).
Age 18 to 75 years of age.
Has a history of UC diagnosis at least 6 months prior to screening; the UC diagnosis must be confirmed by endoscopic and histologic evidence in the subject chart prior to subject’s screening. (The histologic evidence may be obtained and confirmed at Screening based on biopsy collection during the screening sigmoidoscopy with histologic evaluation of the biopsy.).
Note: If no complete colonoscopy (adequate in quality to assess for dysplasia and colorectal polyps) has been performed and documented (with reports) within the past 1 year as recommended by local and national guidelines depending on Colorectal cancer risk factors in the specified subject, a full colonoscopy should be performed at screening. If such results are available within one year, a flexible sigmoidoscopy with examination up to the splenic flexure will be used for screening.
• Has active UC defined as a MES ≥2 during screening sigmoidoscopy, and fecal calprotectin > 250 mcg/g.
• Has evidence of endoscopic disease extending to at least 5 cm proximal to the anal verge, and minimum involvement of at least 50% of the macroscopically most affected colonic segment, i.e., in case of proctitis at least 50% of the rectum must be involved, in case of left-sided colitis at least 50% of the rectum or the sigmoid colon must be involved, etc. This will be confirmed by a central reader.
• Demonstrated intolerance, lack of response or inadequate response to aminosalicylates, and naïve to anti-TNF or other biologic, and/or small molecule therapies.