A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004491-35-RO

Enrollment

206

Registered

2022-03-18

Start date

2020-01-30

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: Itacitinib Product Code: INCB039110 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: ITACITINIB ADIPATE CAS Number: 1334302-63-4 Current Sponsor code: INCB039110 ADIPAT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must be = 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: 1. Displaying clinical signs of fulminant colitis or toxic megacolon. 2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease. 3. Participants with disease limited to the distal 15 cm of the colon. 4. Participants receiving (or expected to receive) the following therapies within the designated timeframe below before the baseline visit or during the study: a. 1 year (52 weeks): Anti-adhesion molecule therapy (eg, natalizumab, vedolizumab, or any investigational anti-adhesion molecule therapy). b. 8 weeks: - Anti-TNF therapy (eg, infliximab, adalimumab, golimumab, or certolizumab). - Interferon therapy. c. 4 weeks: - Cyclosporine, mycophenolate, or tacrolimus. - A daily dose of oral corticosteroids = 30 mg prednisone or equivalent. - Intravenous corticosteroids. d. 2 weeks: - Rectally administered formulation of corticosteroids or 5-ASA. - AZA, 6-MP, or methotrexate

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of itacitinib in inducing a Clinical Response in participants with moderate to severe Ulcerative Colitis.;Secondary Objective: - To evaluate the efficacy of itacitinib on endoscopic, clinical, and Quality of Life outcomes in participants with moderate to severe UC. - To explore the safety and tolerability of itacitinib in participants with UC. - To explore the PK of itacitinib in participants with UC.;Primary end point(s): Proportion of participants with a Clinical Response at Week 12.;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: To evaluate the efficacy of itacitinib in inducing a Clinical Response in participants with moderate to severe Ulcerative Colitis.;Secondary Objective: - To evaluate the efficacy of itacitinib on endoscopic, clinical, and Quality of Life outcomes in participants with moderate to severe UC. - To explore the safety and tolerability of itacitinib in participants with UC. - To explore the PK of itacitinib in participants with UC.;Primary end point(s): Proportion of participants with a Clinical Response at Week 12.;Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of participants with Endoscopic Response at Week 12. • Proportion of participants with Mucosal Healing at Week 12. • Proportion of participants in Endoscopic Remission at Week 12. • Proportion of participants in Clinical Remission at Week 12. • Proportion of participants in each category (0, 1, 2, or 3) for each of the 3-component Mayo subscores (stool frequency, rectal bleeding, mMES). • Change from baseline at Week 12 in 3-component Mayo score. • Change from baseline to Week 12 in PGA score. • Change in Quality of Life score as measured by the IBDQ at Weeks 4 and 12. Monitoring the incidence, duration, and severity of AEs; performing physical examinations; collecting vital signs; and collecting ECGs and laboratory data for hematology, serum chemistry, and urinalysis. • Plasma concentrations of itacitinib at Weeks 2, 4, and 12 for determination of Cmin, Cmax and, data permitting, AUC0-t, CL/F, Vz/F, half-life, and Tmax. • Stool concentrations of itacitinib at Week 4 following 24-hour collection.;Timepoint(s) of evaluation of this end point: Week 2, 4, 12	—

Measure

Time frame

Secondary end point(s): • Proportion of participants with Endoscopic Response at Week 12. • Proportion of participants with Mucosal Healing at Week 12. • Proportion of participants in Endoscopic Remission at Week 12. • Proportion of participants in Clinical Remission at Week 12. • Proportion of participants in each category (0, 1, 2, or 3) for each of the 3-component Mayo subscores (stool frequency, rectal bleeding, mMES). • Change from baseline at Week 12 in 3-component Mayo score. • Change from baseline to Week 12 in PGA score. • Change in Quality of Life score as measured by the IBDQ at Weeks 4 and 12. Monitoring the incidence, duration, and severity of AEs; performing physical examinations; collecting vital signs; and collecting ECGs and laboratory data for hematology, serum chemistry, and urinalysis. • Plasma concentrations of itacitinib at Weeks 2, 4, and 12 for determination of Cmin, Cmax and, data permitting, AUC0-t, CL/F, Vz/F, half-life, and Tmax. • Stool concentrations of itacitinib at Week 4 following 24-hour collection.;Timepoint(s) of evaluation of this end point: Week 2, 4, 12

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Countries

Czechia, Germany, Poland, Romania, United States

Contacts

Public ContactClinical Trial Information

Incyte Corporation

RA@incyte.com13024252734

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026