Health TrialsbyHealthPanel

Etrasimod as Prevention of Pouchitis

ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMaia Kayal

About this trial

The researchers propose conducting a multi-center, randomized, placebo-controlled study to investigate the potential role of etrasimod for the primary and secondary prevention of pouchitis among high-risk patients submitted to total proctocolectomy (TPC) with ileal-pouch anal anastomosis (IPAA) for medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥ 18 years (verified at screening)

Ability to provide written informed consent and to be compliant with protocol assessments (verified at screening)

Diagnosed with UC and underwent TPC with IPAA for medically refractory disease or dysplasia (verified at screening)

Screening may take place at any time from one month to two years after the final surgical stage

Disqualifiers

Isolated cuffitis (verified at screening pouchoscopy)

Diagnosis of Crohn's disease (verified at screening)

Diagnosis of Crohn's disease-like pouch inflammation (verified at screening)

Diagnosis of chronic pouchitis (verified at screening)

Trial design

Design model

Parallel

Treatments tested in this trial

  • etrasimod

    Drug

    2 mg once daily for 48 weeks

  • Placebo

    Drug

    matching placebo for 48 weeks

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: etrasimodActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with at least 1 episode of acute pouchitis

The proportion of patients with at least 1 episode of acute pouchitis during the 48 weeks of treatment. Acute Pouchitis defined as: modified pouchitis disease activity index (mPDAI) score ≥ 5 points OR an increase of ≥ 2 points vs. baseline, AND Endoscopic component of the mPDAI Score \>= 2 points (within 7 days prior or post the collection date of the symptomatic component of the mPDAI score)

Time frame
48 weeks

Secondary outcomes

1

Time to first episode of acute pouchitis

Time to first episode of acute pouchitis (days)

Time frame
end of study at 48 weeks
2

Proportion of patients with acute pouchitis

Proportion of patients with acute pouchitis by Weeks 12, 24 and 36 Acute Pouchitis defined as: mPDAI\* score ≥ 5 points OR an increase of ≥ 2 points vs. baseline, AND Endoscopic component of the mPDAI Score \>= 2 points (within 7 days prior or post the collection date of the symptomatic component of the mPDAI score)

Time frame
Weeks 12, 24 and 36
3

Number of participants with clinical remission

Clinical remission based on mPDAI score at Week 48 Clinical remission is defined as a mPDAI score \< 5 points. The modified PDAI (mPDAI) is calculated from 2 separate 6-point scales assessing clinical symptoms and endoscopic findings with full scale scored from 0-12. Patients are classified as either having pouchitis (PDAI score ≥5) or as not having pouchitis (PDAI score \<5). Greater clinical scores and endoscopy scores correspond to worse disease severity.

Time frame
end of study at 48 weeks
4

Number of episodes of acute pouchitis

Number of episodes of acute pouchitis during the 48-week treatment period

Time frame
end of study at 48 weeks

Other outcomes

Sponsors and contacts

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

Maia Kayal

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Pfizer

Collaborator

Source ClinicalTrials.gov
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