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

Conditions

• Moderate Ulcerative Colitis
• Severe Ulcerative Colitis
• Ulcerative Colitis (UC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• PALI-2108 — DRUG
  Oral Dose
• PALI-2108 — DRUG
  Oral Dose
• Placebo — DRUG
  Oral Dose

Study Details

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.

Key Dates

First listed

Sep 29, 2026

Start date

Aug 28, 2026

Status verified

Sep 2026

Primary completion

Oct 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

204 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PALI-2108 Dose 1
  15mg QD
• Experimental: PALI-2108 Dose 2
  30mg QD
• Placebo Comparator: Placebo
  QD

Primary Outcome Measure

Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12. [ Time Frame: Week 12 ]

Locations (30)

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