Ulcerative Colitis study: PALI-2108
Official title A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07845487
What this study is testing
What is PALI-2108?
PALI-2108 is an investigational oral medication being studied for moderate to severe ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well PALI-2108 works, how safe it is, and how the body reacts to it.
- Who it's for
- Adults with moderate or severe ulcerative colitis.
- What's involved
- Participants will receive either PALI-2108 or a placebo and will have regular visits and tests to monitor their condition.
- Time commitment
- The study lasts several weeks, with multiple clinic visits for dosing and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- mMS of 5 to 9 (inclusive), AND
- ES ≥ 2, AND
- RB ≥ 1.
You likely can't join if
- 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...
- Failure or intolerance of \> 3 classes of approved advanced therapies or \> 4 approved individual advanced therapies.
See the full eligibility 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.
- mMS of 5 to 9 (inclusive), AND
- ES ≥ 2, AND
- RB ≥ 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Sun City, Arizona, United States
- San Diego, California, United States
- Bristol, Connecticut, United States
- Orlando, Florida, United States
- Des Plaines, Illinois, United States
- Glenview, Illinois, United States
- Gurnee, Illinois, United States
- Baton Rouge, Louisiana, United States
- Mandeville, Louisiana, United States
- Tupelo, Mississippi, United States
- St Louis, Missouri, United States
- Clifton, New Jersey, United States
- Albany, New York, United States
- Rochester, New York, United States
- Brunswick, Ohio, United States
- Dayton, Ohio, United States
- Westlake, Ohio, United States
- Providence, Rhode Island, United States
- Cordova, Tennessee, United States
- Garland, Texas, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sun City, Arizona, United States; San Diego, California, United States; Bristol, Connecticut, United States; Orlando, Florida, United States; Des Plaines, Illinois, United States; Glenview, Illinois, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.