A Phase 2 interventional study of PALI-2108 and PALI-2108 in Ulcerative Colitis (UC), Severe Ulcerative Colitis and Moderate Ulcerative Colitis, sponsored by Palisade Bio. Recruiting at 115 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Palisade Bio · Phase 2, Interventional, and Treatment
The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body responds to it.
Key Inclusion Criteria:
Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
Moderately to severely active UC, defined as:
Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed under item b:
a. History of inadequate response or loss of response, or intolerance to at least one prior UC therapy, defined as: i. Oral prednisone ≥ 40 mg/day (or equivalent) or budesonide ≥ 9 mg/day for ≥ 2 weeks.
ii. Corticosteroid dependence: unable to taper \< 10 mg/day prednisone equivalent within 3 months, or relapse within 3 months of discontinuation.
iii. Immunosuppressants: azathioprine ≥ 2 mg/kg/day, 6-mercaptopurine (6-MP) ≥ 1.0 mg/kg/day (or therapeutic 6-thioguanine nucleotide [6-TGN] level) for ≥ 12 weeks, or methotrexate ≥ 15 mg/week subcutaneous or intramuscular.
iv. Approved advanced therapies at the approved labelled dose:
Note: Demonstration of intolerance requires no minimum dose nor duration of use.
b. Currently receiving one or more of the following treatments: i. Stable oral prednisone at ≤ 20 mg/day (or equivalent) or budesonide ≤ 9 mg for ≥ 2 weeks prior to randomization.
ii. Stable dose of thiopurine (azathioprine or 6-MP) for ≥ 4 weeks prior to randomization, and have started the treatment ≥ 12 weeks prior to randomization.
iii. Stable dose of oral aminosalicylates for ≥ 2 weeks prior to randomization.
Key Exclusion Criteria:• Diagnosis of Crohn's disease or IBD-Unclassified (IBD-U; indeterminate colitis) or a history of ischemic colitis or radiation colitis.
15mg QD
Drug: PALI-2108
30mg QD
Drug: PALI-2108
QD
Drug: Placebo
Oral Dose
Oral Dose
Oral Dose
Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Time frame: Week 12
Proportion of participants with clinical response using 3-component mMS at Week 12.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Time frame: At 12 weeks
Proportion of participants with endoscopic improvement at Week 12.
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Time frame: Week 12
Proportion of participants with HEMI at Week 12.
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Time frame: Week 12
Proportion of participants with clinical remission using the 3-component mMS at Week 48.
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Time frame: Week 48
Proportion of participants with endoscopic improvement at Week 48.
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Time frame: Week 48
Proportion of participants with HEMI at Week 48
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Time frame: Week48
Showing the first 100 of 115 sites across 12 countries.
Plan to share: Undecided
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