A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis
Palisade Bio · NCT07845487
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 204
- US sites recruiting
- 28
- Study start
- August 28, 2026
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: PALI-2108; PALI-2108; Placebo
Conditions: Ulcerative Colitis (UC); Severe Ulcerative Colitis; Moderate Ulcerative Colitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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:
- 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. 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.
Recruiting US locations
Site US-022
Sun City, AZ 85351
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-018
San Diego, CA 92103
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-028
Bristol, CT 06010
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-026
Orlando, FL 32825
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-005
Des Plaines, IL 60016
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-007
Glenview, IL 60026
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-020
Gurnee, IL 60031
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-011
Mandeville, LA 70471
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-006
St Louis, MO 63141
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-014
Clifton, NJ 07013
Site contact: ASCENTRA-UC · (858) 704-4900 · ASCENTRA-UC@palisadebio.com
Site US-002
Albany, NY 12206
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-016
Rochester, NY 14618
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-025
Brunswick, OH 44212
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-023
Dayton, OH 45415
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-027
Westlake, OH 44145
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-019
Providence, RI 02905
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-003
Cordova, TN 38018
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-024
Garland, TX 75044
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-009
Georgetown, TX 78628
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-030
Houston, TX 77024
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-015
Lubbock, TX 79424
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-017
Mansfield, TX 760063
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-001
Southlake, TX 76092
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-004
Tyler, TX 75701
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-013
Richmond, VA 23229
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-021
Bellevue, WA 98004
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-029
Tacoma, WA 98405
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com
Site US-012
Milwaukee, WI 53215
Site contact: ASCENTRA-UC · (858)704-4900 · ASCENTRA-UC@palisadebio.com