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

NCT07845487 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PBI-2108-202
• Study Type: interventional
• Target: 204
• Locations: 12 countries
• Sites: 115

Brief Summary

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.

Conditions

Ulcerative Colitis (UC); Severe Ulcerative Colitis; Moderate Ulcerative Colitis

Keywords

Colitis; Ulcerative Colitis; Inflammatory Bowel Disease; IBD

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at 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 Outcomes (6)

• Proportion of participants with clinical response using 3-component mMS at Week 12.

  At 12 weeks

• Proportion of participants with endoscopic improvement at Week 12.

  Week 12

• Proportion of participants with HEMI at Week 12.

  Week 12

• Proportion of participants with clinical remission using the 3-component mMS at Week 48.

  Week 48

• Proportion of participants with endoscopic improvement at Week 48.

  Week 48

Study Arms (3)

PALI-2108 Dose 1

EXPERIMENTAL

15mg QD

Drug: PALI-2108

PALI-2108 Dose 2

EXPERIMENTAL

30mg QD

Drug: PALI-2108

Placebo

PLACEBO COMPARATOR

QD

Drug: Placebo

Interventions

PALI-2108 DRUG

Oral Dose

PALI-2108 Dose 1

Placebo DRUG

Oral Dose

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palisade Bio: lead

Study Sites (115)

Site US-022

Sun City, Arizona, 85351, United States

RECRUITING

Site US-018

San Diego, California, 92103, United States

NOT YET RECRUITING

Site US-028

Bristol, Connecticut, 06010, United States

NOT YET RECRUITING

Site US-026

Orlando, Florida, 32825, United States

RECRUITING

Site US-005

Des Plaines, Illinois, 60016, United States

RECRUITING

Site US-007

Glenview, Illinois, 60026, United States

RECRUITING

Site US-020

Gurnee, Illinois, 60031, United States

RECRUITING

Site US-008

Baton Rouge, Louisiana, 70809, United States

NOT YET RECRUITING

Site US-011

Mandeville, Louisiana, 70471, United States

RECRUITING

Site US-010

Tupelo, Mississippi, 38801, United States

NOT YET RECRUITING

Site US-006

St Louis, Missouri, 63141, United States

RECRUITING

Site US-014

Clifton, New Jersey, 07013, United States

RECRUITING

Site US-002

Albany, New York, 12206, United States

RECRUITING

Site US-016

Rochester, New York, 14618, United States

RECRUITING

Site US-025

Brunswick, Ohio, 44212, United States

RECRUITING

Site US-023

Dayton, Ohio, 45415, United States

RECRUITING

Site US-027

Westlake, Ohio, 44145, United States

RECRUITING

Site US-019

Providence, Rhode Island, 02905, United States

RECRUITING

Site US-003

Cordova, Tennessee, 38018, United States

RECRUITING

Site US-024

Garland, Texas, 75044, United States

RECRUITING

Site US-009

Georgetown, Texas, 78628, United States

RECRUITING

Site US-030

Houston, Texas, 77024, United States

RECRUITING

Site US-015

Lubbock, Texas, 79424, United States

RECRUITING

Site US-017

Mansfield, Texas, 760063, United States

RECRUITING

Site US-001

Southlake, Texas, 76092, United States

RECRUITING

Site US-004

Tyler, Texas, 75701, United States

NOT YET RECRUITING

Site US-013

Richmond, Virginia, 23229, United States

RECRUITING

Site US-021

Bellevue, Washington, 98004, United States

RECRUITING

Site US-029

Tacoma, Washington, 98405, United States

RECRUITING

Site US-012

Milwaukee, Wisconsin, 53215, United States

NOT YET RECRUITING

Site CA-005

Calgary, Alberta, T2N 4L7, Canada

NOT YET RECRUITING

Site CA-004

Edmonton, Alberta, T6K 4E8, Canada

NOT YET RECRUITING

Site CA-006

Greater Sudbury, Ontario, P3C1X3, Canada

NOT YET RECRUITING

Site CA-003

London, Ontario, N6K 1M6, Canada

NOT YET RECRUITING

Site CA-002

Scarborough Village, Ontario, M1B3V4, Canada

NOT YET RECRUITING

Site CA-007

Montreal, Quebec, H1T 2M4, Canada

NOT YET RECRUITING

Site CA-001

Montreal, Quebec, H2X 3E4, Canada

NOT YET RECRUITING

Site CZ-005

Brno, 602 00, Czechia

NOT YET RECRUITING

Site CZ-002

Brno, 615 00, Czechia

NOT YET RECRUITING

Site CZ-008

Havířov, 736 01, Czechia

NOT YET RECRUITING

Site CZ-006

Hradec Králové, 500 12, Czechia

NOT YET RECRUITING

Site CZ-007

Prague, 150 00, Czechia

NOT YET RECRUITING

Site CZ-004

Slaný, 274 01, Czechia

NOT YET RECRUITING

Site FR-003

Amiens, 80000, France

NOT YET RECRUITING

Site FR-005

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

Site FR-002

Neuilly-sur-Seine, 92200, France

NOT YET RECRUITING

Site FR-001

Nice, 06200, France

NOT YET RECRUITING

Site FR-004

Saint-Priest-en-Jarez, 42270, France

NOT YET RECRUITING

Site GE-003

Batumi, Quebec, 6010, Georgia

NOT YET RECRUITING

Site GE-007

Tbilisi, Quebec, 0102, Georgia

NOT YET RECRUITING

Site GE-002

Tbilisi, Quebec, 0144, Georgia

NOT YET RECRUITING

Site GE-004

Tbilisi, Quebec, 0159, Georgia

NOT YET RECRUITING

Site GE-008

Tbilisi, Quebec, 0160, Georgia

NOT YET RECRUITING

Site GE-001

Tbilisi, Quebec, 0178, Georgia

NOT YET RECRUITING

Site GE-005

Tbilisi, Quebec, 0180, Georgia

NOT YET RECRUITING

Site GE-006

Tbilisi, Quebec, 0180, Georgia

NOT YET RECRUITING

Site HU-005

Budapest, 1024, Hungary

NOT YET RECRUITING

Site HU-002

Budapest, H-1062, Hungary

NOT YET RECRUITING

Site HU-001

Budapest, H-1088, Hungary

NOT YET RECRUITING

Site HU-004

Debrecen, H-4025, Hungary

NOT YET RECRUITING

Site HU-007

Gyöngyös, H-3200, Hungary

NOT YET RECRUITING

Site HU-006

Tatabánya, H-2800, Hungary

NOT YET RECRUITING

Site HU-003

Veszprém, 8200, Hungary

NOT YET RECRUITING

Site IT-002

Bari, 70124, Italy

NOT YET RECRUITING

Site IT-004

Bologna, 40138, Italy

NOT YET RECRUITING

Site IT-007

Matera, 75100, Italy

NOT YET RECRUITING

Site IT-009

Negrar, 37024, Italy

NOT YET RECRUITING

Site IT-001

Rome, 00128, Italy

NOT YET RECRUITING

Site IT-003

Rome, 00133, Italy

NOT YET RECRUITING

Site IT-008

Rome, 00168, Italy

NOT YET RECRUITING

Site IT-006

Rozzano, 20089, Italy

NOT YET RECRUITING

Site IT-005

San Giovanni Rotondo, 71013, Italy

NOT YET RECRUITING

Site IT-010

Turin, 10126, Italy

NOT YET RECRUITING

Site LV-003

Liepāja, LV-3414, Latvia

NOT YET RECRUITING

Site LV-002

Riga, LV-1002, Latvia

NOT YET RECRUITING

Site LV-001

Riga, LV-1012, Latvia

NOT YET RECRUITING

Site PL-014

Bydgoszcz, 85-794, Poland

NOT YET RECRUITING

Site PL-005

Elblag, 82-300, Poland

NOT YET RECRUITING

Site PL-006

Katowice, 40-748, Poland

NOT YET RECRUITING

Site PL-022

Kielce, 25-375, Poland

NOT YET RECRUITING

Site PL-002

Krakow, 30-363, Poland

NOT YET RECRUITING

Site PL-016

Krakow, 31-228, Poland

NOT YET RECRUITING

Site PL-020

Kłodzko, 57-300, Poland

NOT YET RECRUITING

Site PL-021

Lodz, 91-495, Poland

NOT YET RECRUITING

Site PL-004

Lublin, 20-582, Poland

NOT YET RECRUITING

Site PL-008

Nowy Targ, 34-400, Poland

NOT YET RECRUITING

Site PL-018

Opole, 45-819, Poland

NOT YET RECRUITING

Site PL-003

Poznan, 60-529, Poland

NOT YET RECRUITING

Site PL-010

Sopot, 81-756, Poland

NOT YET RECRUITING

Site PL-012

Staszów, 28-200, Poland

NOT YET RECRUITING

Site PL-001

Szczecin, 71-434, Poland

NOT YET RECRUITING

Site PL-015

Szczecin, 71-685, Poland

NOT YET RECRUITING

Site PL-007

Torun, 87-100, Poland

NOT YET RECRUITING

Site PL-019

Tychy, 43-100, Poland

NOT YET RECRUITING

Site PL-017

Warsaw, 00-189, Poland

NOT YET RECRUITING

Site PL-013

Warsaw, 04-501, Poland

NOT YET RECRUITING

Site PL-009

Wroclaw, 52-416, Poland

NOT YET RECRUITING

Site PL-011

Wroclaw, 53-611, Poland

NOT YET RECRUITING

Site RO-001

Bucharest, 020125, Romania

NOT YET RECRUITING

Site RO-003

Bucharest, 021967, Romania

NOT YET RECRUITING

Site RO-006

Constanța, 900663, Romania

NOT YET RECRUITING

Site RO-004

Ploieşti, 100032, Romania

NOT YET RECRUITING

Site RO-002

Timișoara, 300002, Romania

NOT YET RECRUITING

Site RO-005

Timișoara, 300239, Romania

NOT YET RECRUITING

Site RS-006

Belgrade, 11 000, Serbia

NOT YET RECRUITING

Site RS-001

Belgrade, 11 080, Serbia

NOT YET RECRUITING

Site RS-002

Belgrade, 11000, Serbia

NOT YET RECRUITING

Site RS-004

Leskovac, 16000, Serbia

NOT YET RECRUITING

Site RS-005

Užice, 31000, Serbia

NOT YET RECRUITING

Site RS-003

Zrenjanin, 23 000, Serbia

NOT YET RECRUITING

Site SK-001

Banská Bystrica, 975 17, Slovakia

NOT YET RECRUITING

Site SK-004

Košice, 040 13, Slovakia

NOT YET RECRUITING

Site SK-002

Prešov, 080 01, Slovakia

NOT YET RECRUITING

Site SK-005

Prešov, 080 01, Slovakia

NOT YET RECRUITING

Site SK-006

Zvolen, 960 01, Slovakia

NOT YET RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

IT (10); PL (22); FR (5); SE (6); CA (7); LA (3); RO (6); SL (5); CZ (6); GE (8); US (30); HU (7)