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

NCT03627052 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: INCB 39110-210
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Moderate to Severe Ulcerative Colitis

Keywords

Inflammatory bowel disease; ulcerative colitis; Janus kinase inhibitor; JAK1

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with a Clinical Response

  To evaluate the efficacy of itacitinib inducing a Clinical Response.

  Week 8

Secondary Outcomes (11)

• Proportion of participants with Endoscopic Response

  Week 8

• Proportion of participants with Mucosal Healing

  Week 8

• Proportion of participants in Endoscopic Remission

  Week 8

• Proportion of participants in Clinical Remission

  Week 8

• Change from baseline in 3-component Mayo score

  Week 8

Study Arms (2)

Itacitinib

EXPERIMENTAL

Drug: Itacitinib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Itacitinib DRUG

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.

Also known as: INCB039110

Itacitinib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

itacitinib; INCB039110

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Kurt Brown, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: September 20, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share