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

ConditionsUlcerative Colitis (UC)Severe Ulcerative ColitisModerate Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPalisade Bio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

mMS of 5 to 9 (inclusive), AND

ES ≥ 2, AND

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PALI-2108

    Drug

    Oral Dose

  • PALI-2108

    Drug

    Oral Dose

  • Placebo

    Drug

    Oral Dose

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: PALI-2108 Dose 1Experimental treatment 1 intervention
Group B: PALI-2108 Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

1

Proportion of participants with clinical response using 3-component 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.

Time frame
At 12 weeks
2

Proportion of participants with endoscopic improvement at 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.

Time frame
Week 12
3

Proportion of participants with HEMI at 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).

Time frame
Week 12
4

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

Time frame
Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Palisade Bio

Lead sponsor

Source ClinicalTrials.gov
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