A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Incyte Corporation0 sitesSeptember 20, 2018

Overview

The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).

Registry

clinicaltrials.gov

Start Date

September 20, 2018

End Date

November 13, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence.
•Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥
•Must have failed or be intolerant to (discontinued the medication due to an adverse event as determined by the investigator) at least 1 of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine, biologic therapy (eg, infliximab, vedolizumab or adalimumab).
•Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving acceptable and stable dose(s): oral 5-ASA or oral corticosteroids.
•No evidence of active or latent or inadequately treated tuberculosis infection.
•Willingness to avoid pregnancy or fathering children.

•Clinical signs of fulminant colitis or toxic megacolon.
•Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.
•Disease limited to the distal 15 cm of the colon.
•Receiving (or expected to receive) the following therapies within protocol-designated timeframes before the baseline visit or during the study: Natalizumab; anti-TNF therapy; Vedolizumab or any investigational anti-adhesion molecule therapy; Ustekinumab or any on or off label biologic therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 25 mg prednisone or equivalent; intravenous corticosteroids; rectally administered formulation of corticosteroids or 5-aminosalicylic acid; and AZA, 6-MP, or methotrexate.
•Enema treatments within 2 weeks of the baseline visit, with the exception of enema bowel preparations for clinical assessments.
•Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin at the screening visit.
•Other immunocompromised states and history of opportunistic infections.
•History of stomach or intestinal surgery, including bariatric surgery (Note: appendectomy and/or cholecystectomy, is allowed).
•o surgery for UC or likely to require surgery for UC during the study.
•If at risk for colorectal cancer, must have had a colonoscopy within protocol-defined timeframes.

Intervention: Itacitinib

Intervention: Placebo

Proportion of participants with a Clinical Response

Time Frame: Week 8

To evaluate the efficacy of itacitinib inducing a Clinical Response.

Stool concentration of itacitinib -~30-hr collection(Week 4)
Proportion of participants with Mucosal Healing(Week 8)
Proportion of participants in Endoscopic Remission(Week 8)
Change from baseline in 3-component Mayo score(Week 8)
Cmax of itacitinib(Week 4)
Proportion of participants with Endoscopic Response(Week 8)
Change from baseline in Physician's Global Assessment score(Week 8)
Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 8)
Number of treatment-emergent adverse events(Up to approximately 60 weeks)
Proportion of participants in Clinical Remission(Week 8)
Ctau of itacitinib(Weeks 2 and 4)