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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

204

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • Arizona
      • Sun City, Arizona, Forente stater, 85351
    • California
      • San Diego, California, Forente stater, 92103
    • Connecticut
      • Bristol, Connecticut, Forente stater, 06010
    • Florida
      • Orlando, Florida, Forente stater, 32825
    • Illinois
      • Des Plaines, Illinois, Forente stater, 60016
      • Glenview, Illinois, Forente stater, 60026
      • Gurnee, Illinois, Forente stater, 60031
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
      • Mandeville, Louisiana, Forente stater, 70471
    • Mississippi
      • Tupelo, Mississippi, Forente stater, 38801
    • Missouri
      • St Louis, Missouri, Forente stater, 63141
    • New Jersey
      • Clifton, New Jersey, Forente stater, 07013
    • New York
      • Albany, New York, Forente stater, 12206
      • Rochester, New York, Forente stater, 14618
    • Ohio
      • Brunswick, Ohio, Forente stater, 44212
      • Dayton, Ohio, Forente stater, 45415
      • Westlake, Ohio, Forente stater, 44145
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02905
    • Tennessee
      • Cordova, Tennessee, Forente stater, 38018
    • Texas
      • Garland, Texas, Forente stater, 75044
      • Georgetown, Texas, Forente stater, 78628
      • Houston, Texas, Forente stater, 77024
      • Lubbock, Texas, Forente stater, 79424
      • Mansfield, Texas, Forente stater, 760063
      • Southlake, Texas, Forente stater, 76092
      • Tyler, Texas, Forente stater, 75701
    • Virginia
      • Richmond, Virginia, Forente stater, 23229
    • Washington
      • Bellevue, Washington, Forente stater, 98004
      • Tacoma, Washington, Forente stater, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53215
  • Frankrike
      • Amiens, Frankrike, 80000
      • Clermont-Ferrand, Frankrike, 63003
      • Neuilly-sur-Seine, Frankrike, 92200
      • Nice, Frankrike, 06200
      • Saint-Priest-en-Jarez, Frankrike, 42270
  • Georgia
    • Quebec
      • Batumi, Quebec, Georgia, 6010
      • Tbilisi, Quebec, Georgia, 0102
      • Tbilisi, Quebec, Georgia, 0144
      • Tbilisi, Quebec, Georgia, 0159
      • Tbilisi, Quebec, Georgia, 0160
      • Tbilisi, Quebec, Georgia, 0178
      • Tbilisi, Quebec, Georgia, 0180
      • Tbilisi, Quebec, Georgia, 0180
  • Italia
      • Bari, Italia, 70124
      • Bologna, Italia, 40138
      • Matera, Italia, 75100
      • Negrar, Italia, 37024
      • Rome, Italia, 00128
      • Rome, Italia, 00133
        • Har ikke rekruttert ennå
        • Site IT-003
        • Ta kontakt med:
      • Rome, Italia, 00168
      • Rozzano, Italia, 20089
      • San Giovanni Rotondo, Italia, 71013
      • Turin, Italia, 10126
  • Latvia
      • Liepāja, Latvia, LV-3414
      • Riga, Latvia, LV-1002
      • Riga, Latvia, 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
  • Romania
      • Bucharest, Romania, 020125
      • Bucharest, Romania, 021967
      • Constanța, Romania, 900663
      • Ploieşti, Romania, 100032
      • Timișoara, Romania, 300002
      • Timișoara, Romania, 300239
  • Serbia
      • Belgrade, Serbia, 11 000
      • Belgrade, Serbia, 11 080
      • Belgrade, Serbia, 11000
      • Leskovac, Serbia, 16000
      • Užice, Serbia, 31000
      • Zrenjanin, Serbia, 23 000
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
      • Košice, Slovakia, 040 13
      • Prešov, Slovakia, 080 01
      • Prešov, Slovakia, 080 01
      • Zvolen, Slovakia, 960 01
  • Tsjekkia
      • Brno, Tsjekkia, 602 00
      • Brno, Tsjekkia, 615 00
      • Havířov, Tsjekkia, 736 01
      • Hradec Králové, Tsjekkia, 500 12
      • Prague, Tsjekkia, 150 00
      • Slaný, Tsjekkia, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PALI-2108 Dose 1

15mg QD
Legemiddel: PALI-2108

Oral Dose
Eksperimentell: PALI-2108 Dose 2

30mg QD
Legemiddel: PALI-2108

Oral Dose
Placebo komparator: Placebo

QD
Legemiddel: Placebo

Oral Dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Palisade Bio

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

21. september 2026

Først innsendt som oppfylte QC-kriteriene

22. september 2026

Først lagt ut (Faktiske)

29. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PBI-2108-202

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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