PALI-2108 vs placebo for moderate to severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, placebo-controlled study evaluating the safety and effectiveness of PALI-2108 in adults with moderately to severely active ulcerative colitis. Participants receive either PALI-2108 at specified doses or a placebo, with outcomes focused on symptom improvement and safety signals over the trial period. Eligibility requires confirmed UC with active disease and prior exposure or intolerance to at least one UC therapy. The study aims to understand how well the drug works, how patients tolerate it, and how their bodies respond biologically. Investigators will monitor clinical outcomes, endoscopic findings, and safety data to characterize the treatment effect.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site US-022
  Sun City, Arizona, United States Recruiting
• Site US-018
  San Diego, California, United States Recruiting
• Site US-028
  Bristol, Connecticut, United States 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

+65 more sites. See ClinicalTrials.gov for the full list.

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.