The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID. Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
169
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
Time frame: Week 12
Comparison between PN-943 high-dose and low-dose individually to placebo.
1. Proportion of subjects with endoscopic improvement. 2. Proportion of subjects achieving endoscopic remission. 3. Proportion of subjects with histological improvement. 4. Proportion of subjects achieving histological remission. 5. Proportion of subjects with mucosal healing.
Time frame: Week 12
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