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A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627052
Recruitment Status : Withdrawn (Study withdrawn due to lack of recruitment. No patients enrolled. No safety concerns.)
First Posted : August 13, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
Moderate to Severe Ulcerative Colitis Drug: Itacitinib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 20, 2018
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itacitinib Drug: Itacitinib
In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. In the open-label extension, itacitinib administered at doses determined from the double-blind period.
Other Name: INCB039110

Placebo Comparator: Placebo Drug: Placebo
Placebo administered orally twice daily in the double-blind period.




Primary Outcome Measures :
  1. Proportion of participants with a Clinical Response [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib inducing a Clinical Response.


Secondary Outcome Measures :
  1. Proportion of participants with Endoscopic Response [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on endoscopic outcomes.

  2. Proportion of participants with Mucosal Healing [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on endoscopic outcomes.

  3. Proportion of participants in Endoscopic Remission [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on endoscopic outcomes.

  4. Proportion of participants in Clinical Remission [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on clinical outcomes.

  5. Change from baseline in 3-component Mayo score [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on clinical outcomes.

  6. Change from baseline in Physician's Global Assessment score [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on clinical outcomes.

  7. Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 8 ]
    To evaluate the efficacy of itacitinib on quality of life outcomes.

  8. Cmax of itacitinib [ Time Frame: Week 4 ]
    Maximum observed plasma concentrations.

  9. Ctau of itacitinib [ Time Frame: Weeks 2 and 4 ]
    Plasma concentrations

  10. Stool concentration of itacitinib -~30-hr collection [ Time Frame: Week 4 ]
  11. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 60 weeks ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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: 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: 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627052


Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kurt Brown, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03627052    
Other Study ID Numbers: INCB 39110-210
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Inflammatory bowel disease
ulcerative colitis
Janus kinase inhibitor
JAK1
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases