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

20. oktober 2026 opdateret af: Palisade Bio

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

204

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
      • Edmonton, Alberta, Canada, T6K 4E8
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3C1X3
      • London, Ontario, Canada, N6K 1M6
      • Scarborough Village, Ontario, Canada, M1B3V4
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2X 3E4
  • Forenede Stater
    • Arizona
      • Sun City, Arizona, Forenede Stater, 85351
    • California
      • San Diego, California, Forenede Stater, 92103
    • Connecticut
      • Bristol, Connecticut, Forenede Stater, 06010
    • Florida
      • Orlando, Florida, Forenede Stater, 32825
    • Illinois
      • Des Plaines, Illinois, Forenede Stater, 60016
      • Glenview, Illinois, Forenede Stater, 60026
      • Gurnee, Illinois, Forenede Stater, 60031
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
      • Mandeville, Louisiana, Forenede Stater, 70471
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63141
    • New Jersey
      • Clifton, New Jersey, Forenede Stater, 07013
    • New York
      • Albany, New York, Forenede Stater, 12206
      • Rochester, New York, Forenede Stater, 14618
    • Ohio
      • Brunswick, Ohio, Forenede Stater, 44212
      • Dayton, Ohio, Forenede Stater, 45415
      • Westlake, Ohio, Forenede Stater, 44145
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
    • Tennessee
      • Cordova, Tennessee, Forenede Stater, 38018
    • Texas
      • Garland, Texas, Forenede Stater, 75044
      • Georgetown, Texas, Forenede Stater, 78628
      • Houston, Texas, Forenede Stater, 77024
      • Lubbock, Texas, Forenede Stater, 79424
      • Mansfield, Texas, Forenede Stater, 760063
      • Southlake, Texas, Forenede Stater, 76092
      • Tyler, Texas, Forenede Stater, 75701
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
      • Tacoma, Washington, Forenede Stater, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
  • Frankrig
      • Amiens, Frankrig, 80000
      • Clermont-Ferrand, Frankrig, 63003
      • Neuilly-sur-Seine, Frankrig, 92200
      • Nice, Frankrig, 06200
      • Saint-Priest-en-Jarez, Frankrig, 42270
  • Georgien
    • Quebec
      • Batumi, Quebec, Georgien, 6010
      • Tbilisi, Quebec, Georgien, 0102
      • Tbilisi, Quebec, Georgien, 0144
      • Tbilisi, Quebec, Georgien, 0159
      • Tbilisi, Quebec, Georgien, 0160
      • Tbilisi, Quebec, Georgien, 0178
      • Tbilisi, Quebec, Georgien, 0180
      • Tbilisi, Quebec, Georgien, 0180
  • Italien
      • Bari, Italien, 70124
      • Bologna, Italien, 40138
      • Matera, Italien, 75100
      • Negrar, Italien, 37024
      • Rome, Italien, 00128
      • Rome, Italien, 00133
        • Ikke rekrutterer endnu
        • Site IT-003
        • Kontakt:
      • Rome, Italien, 00168
      • Rozzano, Italien, 20089
      • San Giovanni Rotondo, Italien, 71013
      • Turin, Italien, 10126
  • Letland
      • Liepāja, Letland, LV-3414
      • Riga, Letland, LV-1002
      • Riga, Letland, LV-1012
  • Polen
      • Bydgoszcz, Polen, 85-794
      • Elblag, Polen, 82-300
      • Katowice, Polen, 40-748
      • Kielce, Polen, 25-375
      • Krakow, Polen, 30-363
      • Krakow, Polen, 31-228
      • Kłodzko, Polen, 57-300
      • Lodz, Polen, 91-495
      • Lublin, Polen, 20-582
      • Nowy Targ, Polen, 34-400
      • Opole, Polen, 45-819
      • Poznan, Polen, 60-529
      • Sopot, Polen, 81-756
      • Staszów, Polen, 28-200
      • Szczecin, Polen, 71-434
      • Szczecin, Polen, 71-685
      • Torun, Polen, 87-100
      • Tychy, Polen, 43-100
      • Warsaw, Polen, 00-189
      • Warsaw, Polen, 04-501
      • Wroclaw, Polen, 52-416
      • Wroclaw, Polen, 53-611
  • Rumænien
      • Bucharest, Rumænien, 020125
      • Bucharest, Rumænien, 021967
      • Constanța, Rumænien, 900663
      • Ploieşti, Rumænien, 100032
      • Timișoara, Rumænien, 300002
      • Timișoara, Rumænien, 300239
  • Serbien
      • Belgrade, Serbien, 11 000
      • Belgrade, Serbien, 11 080
      • Belgrade, Serbien, 11000
      • Leskovac, Serbien, 16000
      • Užice, Serbien, 31000
      • Zrenjanin, Serbien, 23 000
  • Slovakiet
      • Banská Bystrica, Slovakiet, 975 17
      • Košice, Slovakiet, 040 13
      • Prešov, Slovakiet, 080 01
      • Prešov, Slovakiet, 080 01
      • Zvolen, Slovakiet, 960 01
  • Tjekkiet
      • Brno, Tjekkiet, 602 00
      • Brno, Tjekkiet, 615 00
      • Havířov, Tjekkiet, 736 01
      • Hradec Králové, Tjekkiet, 500 12
      • Prague, Tjekkiet, 150 00
      • Slaný, Tjekkiet, 274 01
  • Ungarn
      • Budapest, Ungarn, 1024
      • Budapest, Ungarn, H-1062
      • Budapest, Ungarn, H-1088
      • Debrecen, Ungarn, H-4025
      • Gyöngyös, Ungarn, H-3200
      • Tatabánya, Ungarn, H-2800
      • Veszprém, Ungarn, 8200

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PALI-2108 Dose 1

15mg QD
Medicin: PALI-2108

Oral Dose
Eksperimentel: PALI-2108 Dose 2

30mg QD
Medicin: PALI-2108

Oral Dose
Placebo komparator: Placebo

QD
Medicin: Placebo

Oral Dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with clinical response using 3-component mMS at Week 12.
Tidsramme: At 12 weeks

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.
At 12 weeks
Proportion of participants with endoscopic improvement at Week 12.
Tidsramme: Week 12

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Proportion of participants with HEMI at Week 12.
Tidsramme: Week 12

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 12
Proportion of participants with clinical remission using the 3-component mMS at Week 48.
Tidsramme: Week 48

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 48
Proportion of participants with endoscopic improvement at Week 48.
Tidsramme: Week 48

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 48
Proportion of participants with HEMI at Week 48
Tidsramme: Week48

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Palisade Bio

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

21. september 2026

Først indsendt, der opfyldte QC-kriterier

22. september 2026

Først opslået (Faktiske)

29. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PBI-2108-202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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