Clinical trial NCT04580277: Tofacitinib For Treatment Of Chronic Pouchitis
Official title: A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pouchitis
Ileal Pouchitis
Ileal Pouch
Keywords: chronic pouchitis
tofacitinib
antibiotic-refractory pouchitis
antibiotic-dependent pouchitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Clinical Response/Remission
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: 8 weeks
measure: Number of Participants With Clinical Remission
timeFrame: 8 weeks
measure: Change in mPDAI Score
timeFrame: 8 weeks
measure: Change in mPDAI Clinical Sub-score
timeFrame: 8 weeks
measure: Change in mPDAI Endoscopic Sub-score
timeFrame: 8 weeks
measure: Change in IBD-related Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References: