NCT07845487From ClinicalTrials.govRecruiting

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

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

Ulcerative Colitis (UC)
Severe Ulcerative Colitis
Moderate Ulcerative Colitis

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Palisade Bio
Enrolment target: 204
Started: 28 August 2026
Main results due: October 2027
Study sites: 115
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(115)

Site US-022
Sun City, Arizona, United States
Recruiting
Site US-018
San Diego, California, United States
Not yet recruiting
Site US-028
Bristol, Connecticut, United States
Not yet recruiting
Site US-026
Orlando, Florida, United States
Recruiting
Site US-005
Des Plaines, Illinois, United States
Recruiting
Site US-007
Glenview, Illinois, United States
Recruiting
Site US-020
Gurnee, Illinois, United States
Recruiting
Site US-008
Baton Rouge, Louisiana, United States
Not yet recruiting
Site US-011
Mandeville, Louisiana, United States
Recruiting
Site US-010
Tupelo, Mississippi, United States
Not yet recruiting
Site US-006
St Louis, Missouri, United States
Recruiting
Site US-014
Clifton, New Jersey, United States
Recruiting
Site US-002
Albany, New York, United States
Recruiting
Site US-016
Rochester, New York, United States
Recruiting
Site US-025
Brunswick, Ohio, United States
Recruiting
Site US-023
Dayton, Ohio, United States
Recruiting
Site US-027
Westlake, Ohio, United States
Recruiting
Site US-019
Providence, Rhode Island, United States
Recruiting
Site US-003
Cordova, Tennessee, United States
Recruiting
Site US-024
Garland, Texas, United States
Recruiting
Site US-009
Georgetown, Texas, United States
Recruiting
Site US-030
Houston, Texas, United States
Recruiting
Site US-015
Lubbock, Texas, United States
Recruiting
Site US-017
Mansfield, Texas, United States
Recruiting
Site US-001
Southlake, Texas, United States
Recruiting
Site US-004
Tyler, Texas, United States
Not yet recruiting
Site US-013
Richmond, Virginia, United States
Recruiting
Site US-021
Bellevue, Washington, United States
Recruiting
Site US-029
Tacoma, Washington, United States
Recruiting
Site US-012
Milwaukee, Wisconsin, United States
Not yet recruiting
Site CA-005
Calgary, Alberta, Canada
Not yet recruiting
Site CA-004
Edmonton, Alberta, Canada
Not yet recruiting
Site CA-006
Greater Sudbury, Ontario, Canada
Not yet recruiting
Site CA-003
London, Ontario, Canada
Not yet recruiting
Site CA-002
Scarborough Village, Ontario, Canada
Not yet recruiting
Site CA-007
Montreal, Quebec, Canada
Not yet recruiting
Site CA-001
Montreal, Quebec, Canada
Not yet recruiting
Site CZ-005
Brno, Czechia
Not yet recruiting
Site CZ-002
Brno, Czechia
Not yet recruiting
Site CZ-008
Havířov, Czechia
Not yet recruiting
Site CZ-006
Hradec Králové, Czechia
Not yet recruiting
Site CZ-007
Prague, Czechia
Not yet recruiting
Site CZ-004
Slaný, Czechia
Not yet recruiting
Site FR-003
Amiens, France
Not yet recruiting
Site FR-005
Clermont-Ferrand, France
Not yet recruiting
Site FR-002
Neuilly-sur-Seine, France
Not yet recruiting
Site FR-001
Nice, France
Not yet recruiting
Site FR-004
Saint-Priest-en-Jarez, France
Not yet recruiting
Site GE-003
Batumi, Quebec, Georgia
Not yet recruiting
Site GE-007
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-002
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-004
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-008
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-001
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-005
Tbilisi, Quebec, Georgia
Not yet recruiting
Site GE-006
Tbilisi, Quebec, Georgia
Not yet recruiting
Site HU-005
Budapest, Hungary
Not yet recruiting
Site HU-002
Budapest, Hungary
Not yet recruiting
Site HU-001
Budapest, Hungary
Not yet recruiting
Site HU-004
Debrecen, Hungary
Not yet recruiting

Showing 60 of 115 sites — filter to narrow it down. 24 of the 115 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07845487. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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