Tofacitinib For Treatment Of Chronic Pouchitis

NCT ID: NCT04580277

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-05-15

Brief Summary

A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis

Detailed Description

The proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. Subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. Eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. They will then receive oral tofacitinib 10 mg twice daily for 8 weeks. Clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. Clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.

Conditions

Pouchitis; Ileal Pouchitis; Ileal Pouch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic pouchitis

This arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks

Group Type: EXPERIMENTAL

Tofacitinib 10 mg

Intervention Type: DRUG

Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks

Interventions

Tofacitinib 10 mg

Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects ages 18 to 80

2. Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.

3. Subjects with pouchitis that is chronic, defined by a mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit

4. Women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing.

Exclusion Criteria

1. Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.

2. Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.

3. Subjects with prior exposure to tofacitinib.

4. Subjects with a diverting stoma.

5. Subjects with a prior history or risk factors for venous thromboembolism.

6. Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.

7. Subjects with a history of latent or active tuberculosis.

8. Subjects positive for hepatitis B virus (HBV) surface antigen, hepatitis B virus core antibody with a negative hepatitis B surface antibody or with detectable serum hepatitis B DNA.

9. Female subjects who are pregnant or lactating.

10. Female subjects of childbearing potential who are sexually active and do not agree to using two highly effective methods of contraception during the study period.

11. Subjects with clinically significant laboratory abnormalities at study screening.

• Other eligibility criteria apply

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gil Melmed

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00000693

Identifier Type: -

Identifier Source: org_study_id