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

  • STATUS
    Recruiting
Updated on 10 May 2022
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 IdentifierTX220945
Last Modified on10 May 2022

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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