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RECRUITING

NCT07845487

PHASE2

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

Sponsor: Palisade Bio

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2026-08-28

Completion Date

2028-06

Last Updated

2026-09-29

Healthy Volunteers

Conditions

Ulcerative Colitis (UC)Severe Ulcerative Colitis Moderate Ulcerative Colitis

Interventions

DRUG

PALI-2108

Oral Dose

DRUG

PALI-2108

Oral Dose

DRUG

Placebo

Oral Dose

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.

Locations (115)

Site US-022

Sun City, Arizona, United States

Site US-018

San Diego, California, United States

Site US-028

Bristol, Connecticut, United States

Site US-026

Orlando, Florida, United States

Site US-005

Des Plaines, Illinois, United States

Site US-007

Glenview, Illinois, United States

Site US-020

Gurnee, Illinois, United States

Site US-008

Baton Rouge, Louisiana, United States

Site US-011

Mandeville, Louisiana, United States

Site US-010

Tupelo, Mississippi, United States

Site US-006

St Louis, Missouri, United States

Site US-014

Clifton, New Jersey, United States

Site US-002

Albany, New York, United States

Site US-016

Rochester, New York, United States

Site US-025

Brunswick, Ohio, United States

Site US-023

Dayton, Ohio, United States

Site US-027

Westlake, Ohio, United States

Site US-019

Providence, Rhode Island, United States

Site US-003

Cordova, Tennessee, United States

Site US-024

Garland, Texas, United States

Site US-009

Georgetown, Texas, United States

Site US-030

Houston, Texas, United States

Site US-015

Lubbock, Texas, United States

Site US-017

Mansfield, Texas, United States

Site US-001

Southlake, Texas, United States

Site US-004

Tyler, Texas, United States

Site US-013

Richmond, Virginia, United States

Site US-021

Bellevue, Washington, United States

Site US-029

Tacoma, Washington, United States

Site US-012

Milwaukee, Wisconsin, United States

Site CA-005

Calgary, Alberta, Canada

Site CA-004

Edmonton, Alberta, Canada

Site CA-006

Greater Sudbury, Ontario, Canada

Site CA-003

London, Ontario, Canada

Site CA-002

Scarborough Village, Ontario, Canada

Site CA-007

Montreal, Quebec, Canada

Site CA-001

Montreal, Quebec, Canada

Site CZ-005

Brno, Czechia

Site CZ-002

Brno, Czechia

Site CZ-008

Havířov, Czechia

Site CZ-006

Hradec Králové, Czechia

Site CZ-007

Prague, Czechia

Site CZ-004

Slaný, Czechia

Site FR-003

Amiens, France

Site FR-005

Clermont-Ferrand, France

Site FR-002

Neuilly-sur-Seine, France

Site FR-001

Nice, France

Site FR-004

Saint-Priest-en-Jarez, France

Site GE-003

Batumi, Quebec, Georgia

Site GE-007

Tbilisi, Quebec, Georgia

Site GE-002

Tbilisi, Quebec, Georgia

Site GE-004

Tbilisi, Quebec, Georgia

Site GE-008

Tbilisi, Quebec, Georgia

Site GE-001

Tbilisi, Quebec, Georgia

Site GE-005

Tbilisi, Quebec, Georgia

Site GE-006

Tbilisi, Quebec, Georgia

Site HU-005

Budapest, Hungary

Site HU-002

Budapest, Hungary

Site HU-001

Budapest, Hungary

Site HU-004

Debrecen, Hungary

Site HU-007

Gyöngyös, Hungary

Site HU-006

Tatabánya, Hungary

Site HU-003

Veszprém, Hungary

Site IT-002

Bari, Italy

Site IT-004

Bologna, Italy

Site IT-007

Matera, Italy

Site IT-009

Negrar, Italy

Site IT-001

Rome, Italy

Site IT-003

Rome, Italy

Site IT-008

Rome, Italy

Site IT-006

Rozzano, Italy

Site IT-005

San Giovanni Rotondo, Italy

Site IT-010

Turin, Italy

Site LV-003

Liepāja, Latvia

Site LV-002

Riga, Latvia

Site LV-001

Riga, Latvia

Site PL-014

Bydgoszcz, Poland

Site PL-005

Elblag, Poland

Site PL-006

Katowice, Poland

Site PL-022

Kielce, Poland

Site PL-002

Krakow, Poland

Site PL-016

Krakow, Poland

Site PL-020

Kłodzko, Poland

Site PL-021

Lodz, Poland

Site PL-004

Lublin, Poland

Site PL-008

Nowy Targ, Poland

Site PL-018

Opole, Poland

Site PL-003

Poznan, Poland

Site PL-010

Sopot, Poland

Site PL-012

Staszów, Poland

Site PL-001

Szczecin, Poland

Site PL-015

Szczecin, Poland

Site PL-007

Torun, Poland

Site PL-019

Tychy, Poland

Site PL-017

Warsaw, Poland

Site PL-013

Warsaw, Poland

Site PL-009

Wroclaw, Poland

Site PL-011

Wroclaw, Poland

Site RO-001

Bucharest, Romania

Site RO-003

Bucharest, Romania

Site RO-006

Constanța, Romania

Site RO-004

Ploieşti, Romania

Site RO-002

Timișoara, Romania

Site RO-005

Timișoara, Romania

Site RS-006

Belgrade, Serbia

Site RS-001

Belgrade, Serbia

Site RS-002

Belgrade, Serbia

Site RS-004

Leskovac, Serbia

Site RS-005

Užice, Serbia

Site RS-003

Zrenjanin, Serbia

Site SK-001

Banská Bystrica, Slovakia

Site SK-004

Košice, Slovakia

Site SK-002

Prešov, Slovakia

Site SK-005

Prešov, Slovakia

Site SK-006

Zvolen, Slovakia

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (115)