TerminatedPhase 2

Tofacitinib For Treatment Of Chronic Pouchitis

Stopped: low recruitment

United States6 participantsStarted 2021-01-25

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ages 18 to 80
✓. Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
✓. 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
✓. 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.

✕. Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
✕. Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
✕. Subjects with prior exposure to tofacitinib.
✕. Subjects with a diverting stoma.
✕. Subjects with a prior history or risk factors for venous thromboembolism.
✕. Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.

Number of Participants With Clinical Response/Remission

Timeframe: 8 weeks

NCT IDNCT04580277

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

Results submitted2023-11-22

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ages 18 to 80
✓. Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
✓. 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
✓. 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.

✕. Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
✕. Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
✕. Subjects with prior exposure to tofacitinib.
✕. Subjects with a diverting stoma.
✕. Subjects with a prior history or risk factors for venous thromboembolism.
✕. Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.