Etrasimod for Pouchitis

(ESPIRIT Trial)

Overseen By Maia Kayal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Maia Kayal

Must not be taking: Probiotics, Rectal 5-ASA, Steroids, others

Disqualifiers: Crohn's disease, Chronic pouchitis, Cardiovascular history, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Maia Kayal, MD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

Inclusion Criteria

My symptoms are mild or in remission at the start of the study.

* 12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement (verified at screening)

* Adequate hematological function defined by white blood cell count ≥ 3.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, absolute lymphocyte count (ALC) ≥ 0.8 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 8 g/dL (verified at screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either etrasimod or placebo for the prevention of pouchitis

48 weeks

Regular visits at Weeks 12, 24, 36, and 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod

How Is the Trial Designed?

Group I: etrasimod Active Control 1 Intervention

study drug etrasimod 2 mg once daily for 48 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo for 48 weeks

Who Is Running the Clinical Trial?

Maia Kayal

Lead Sponsor

Trials

1

Recruited

20+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University