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

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Updated on 10 May 2022

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corticosteroids

endoscopy

adalimumab

infliximab

mercaptopurine

vedolizumab

azathioprine

hematochezia

Summary

This Phase 2 study is designed to evaluate the efficacy and safety of itacitinib in men and women with moderate to severe UC. The study consists of Part A and Part B, which consist of 12 weeks of double-blind, randomized, placebo-controlled treatment periods followed by 40 weeks open label extension period.

Description

For more information, please contact Incyte Corporation at 1.855.463.3463

Details

Condition	Ulcerative Colitis
Clinical Study Identifier	TX220945
Last Modified on	10 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 ≥ 1
	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 within 5 years of the screening visit: 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
Exclusion Criteria
	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: anti-adhesion molecule therapy; anti-TNF therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 30 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)
	If at risk for colorectal cancer, must have had a colonoscopy within protocol-defined timeframes
	History of recurrent, disseminated, or multiple dermatomal herpes zoster
	History of alcohol or drug abuse
	History of active malignancy within 5 years of screening, excluding superficial basal and squamous cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix
	Current or recent history (within 30 days before randomization) of a clinically meaningful viral, bacterial, fungal, parasitic, or mycobacterial infection
	Previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis (eg, Cellsorba) within 1 year of baseline
	History of unstable ischemic heart disease or uncontrolled hypertension
	Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for HCV antibody with detectable RNA at screening
	Participants taking potent systemic CYP3A4 inhibitors or inducers or fluconazole within 2 weeks or 5 half-lives (whichever is longer) of baseline
	Participants taking P-gp substrates with narrow therapeutic index, including digoxin within 2 weeks or 5 half-lives (whichever is longer) of baseline

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Study Definition

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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