A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis (ASCENTRA-UC)

October 20, 2026 updated by: Palisade Bio

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Induction and Maintenance Therapy With PALI-2108 in Participants With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
      • Edmonton, Alberta, Canada, T6K 4E8
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3C1X3
      • London, Ontario, Canada, N6K 1M6
      • Scarborough Village, Ontario, Canada, M1B3V4
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2X 3E4
  • Czechia
      • Brno, Czechia, 602 00
      • Brno, Czechia, 615 00
      • Havířov, Czechia, 736 01
      • Hradec Králové, Czechia, 500 12
      • Prague, Czechia, 150 00
      • Slaný, Czechia, 274 01
  • France
      • Amiens, France, 80000
      • Clermont-Ferrand, France, 63003
      • Neuilly-sur-Seine, France, 92200
      • Nice, France, 06200
      • Saint-Priest-en-Jarez, France, 42270
  • Georgia
    • Quebec
      • Batumi, Quebec, Georgia, 6010
      • Tbilisi, Quebec, Georgia, 0102
      • Tbilisi, Quebec, Georgia, 0144
      • Tbilisi, Quebec, Georgia, 0159
      • Tbilisi, Quebec, Georgia, 0160
      • Tbilisi, Quebec, Georgia, 0178
      • Tbilisi, Quebec, Georgia, 0180
      • Tbilisi, Quebec, Georgia, 0180
  • Hungary
      • Budapest, Hungary, 1024
      • Budapest, Hungary, H-1062
      • Budapest, Hungary, H-1088
      • Debrecen, Hungary, H-4025
      • Gyöngyös, Hungary, H-3200
      • Tatabánya, Hungary, H-2800
      • Veszprém, Hungary, 8200
  • Italy
      • Bari, Italy, 70124
      • Bologna, Italy, 40138
      • Matera, Italy, 75100
      • Negrar, Italy, 37024
      • Rome, Italy, 00128
      • Rome, Italy, 00133
      • Rome, Italy, 00168
      • Rozzano, Italy, 20089
      • San Giovanni Rotondo, Italy, 71013
      • Turin, Italy, 10126
  • Latvia
      • Liepāja, Latvia, LV-3414
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1012
  • Poland
      • Bydgoszcz, Poland, 85-794
      • Elblag, Poland, 82-300
      • Katowice, Poland, 40-748
      • Kielce, Poland, 25-375
      • Krakow, Poland, 30-363
      • Krakow, Poland, 31-228
      • Kłodzko, Poland, 57-300
      • Lodz, Poland, 91-495
      • Lublin, Poland, 20-582
      • Nowy Targ, Poland, 34-400
      • Opole, Poland, 45-819
      • Poznan, Poland, 60-529
      • Sopot, Poland, 81-756
      • Staszów, Poland, 28-200
      • Szczecin, Poland, 71-434
      • Szczecin, Poland, 71-685
      • Torun, Poland, 87-100
      • Tychy, Poland, 43-100
      • Warsaw, Poland, 00-189
      • Warsaw, Poland, 04-501
      • Wroclaw, Poland, 52-416
      • Wroclaw, Poland, 53-611
  • Romania
      • Bucharest, Romania, 020125
      • Bucharest, Romania, 021967
      • Constanța, Romania, 900663
      • Ploieşti, Romania, 100032
      • Timișoara, Romania, 300002
      • Timișoara, Romania, 300239
  • Serbia
      • Belgrade, Serbia, 11 000
      • Belgrade, Serbia, 11 080
      • Belgrade, Serbia, 11000
      • Leskovac, Serbia, 16000
      • Užice, Serbia, 31000
      • Zrenjanin, Serbia, 23 000
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
      • Košice, Slovakia, 040 13
      • Prešov, Slovakia, 080 01
      • Prešov, Slovakia, 080 01
      • Zvolen, Slovakia, 960 01
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
    • California
      • San Diego, California, United States, 92103
    • Connecticut
      • Bristol, Connecticut, United States, 06010
    • Florida
      • Orlando, Florida, United States, 32825
    • Illinois
      • Des Plaines, Illinois, United States, 60016
      • Glenview, Illinois, United States, 60026
      • Gurnee, Illinois, United States, 60031
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
      • Mandeville, Louisiana, United States, 70471
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
    • Missouri
      • St Louis, Missouri, United States, 63141
    • New Jersey
      • Clifton, New Jersey, United States, 07013
    • New York
      • Albany, New York, United States, 12206
      • Rochester, New York, United States, 14618
    • Ohio
      • Brunswick, Ohio, United States, 44212
      • Dayton, Ohio, United States, 45415
      • Westlake, Ohio, United States, 44145
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Cordova, Tennessee, United States, 38018
    • Texas
      • Garland, Texas, United States, 75044
      • Georgetown, Texas, United States, 78628
      • Houston, Texas, United States, 77024
      • Lubbock, Texas, United States, 79424
      • Mansfield, Texas, United States, 760063
      • Southlake, Texas, United States, 76092
      • Tyler, Texas, United States, 75701
    • Virginia
      • Richmond, Virginia, United States, 23229
    • Washington
      • Bellevue, Washington, United States, 98004
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    • If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure.

  • Moderately to severely active UC, defined as:

    • mMS of 5 to 9 (inclusive), AND
    • ES ≥ 2, AND
    • RB ≥ 1.

  • 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:

  1. Anti-tumor necrosis factor (TNF), anti-integrin (vedolizumab), or anti-IL-12/23 for at least 8 weeks; anti-IL 23 for at least 12 weeks.
  2. Janus kinase (JAK) inhibitor for at least 8 weeks; sphingosine-1-phosphate receptor (S1PR) modulator for at least 12 weeks.

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.

  • UC limited to rectum (< 15 cm from anal verge).
  • Any prior history of suicidal behavior (actual, interrupted, aborted attempt, or preparatory acts).
  • Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation type 4 or 5, or any active suicidal ideation with some intent to act.
  • Severe depression at Screening based on a validated scale threshold (e.g., Patient Health Questionnaire-9 [PHQ-9] ≥ 20, or PHQ-9 item 9 > 0) at Screening.
  • Failure or intolerance of > 3 classes of approved advanced therapies or > 4 approved individual advanced therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PALI-2108 Dose 1

15mg QD
Drug: PALI-2108

Oral Dose
Experimental: PALI-2108 Dose 2

30mg QD
Drug: PALI-2108

Oral Dose
Placebo Comparator: Placebo

QD
Drug: Placebo

Oral Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
Time Frame: 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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with clinical response using 3-component mMS at Week 12.
Time Frame: At 12 weeks

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.
At 12 weeks
Proportion of participants with endoscopic improvement at Week 12.
Time Frame: 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.
Week 12
Proportion of participants with HEMI at Week 12.
Time Frame: 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).
Week 12
Proportion of participants with clinical remission using the 3-component mMS at Week 48.
Time Frame: 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.
Week 48
Proportion of participants with endoscopic improvement at Week 48.
Time Frame: 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.
Week 48
Proportion of participants with HEMI at Week 48
Time Frame: Week48

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).
Week48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palisade Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 22, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

October 21, 2026

Last Update Submitted That Met QC Criteria

October 20, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBI-2108-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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