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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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