NCT02819635

A Study to Evaluate the Safety and Efficacy of an Active Drug for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

Brief summary

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of an active drug compared to placebo in inducing clinical remission in order to identify the induction dose of an active drug for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of an active drug compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of an active drug compared to placebo in achieving clinical remission in participants who had a response following induction with an active drug.

Interventional study

Status:
Completed
Conditions:
Ulcerative Colitis (UC)
Enrollment:
1302 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-234
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 16 Years to 75 Years.

Inclusion Criteria:

Note: Adolescent participants at the age of 16 or 17 years old will be eligible to
participate if approved by the country or regulatory/health authority. If approval has not
been granted, only participants >= 18 years old will be enrolled.

Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at
Screening Visit.

- Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by
colonoscopy during the Screening Period, with exclusion of current infection, colonic
dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent
with the diagnosis of UC, in the assessment of the Investigator, must be available.

- Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic
sub score of 2 to 3 (confirmed by central reader).

- Demonstrated an inadequate response to, loss of response to, or intolerance to at
least one of the following treatments including: oral aminosalicylates,
corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the
investigator.

Note: Participants who have had inadequate response, loss of response to conventional
therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior
biologic for up to 1 year may be enrolled, however they must have discontinued the biologic
for reasons other than inadequate response or intolerance (e.g., change of insurance, well
controlled disease) and must meet criteria for inadequate response, loss of response or
intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined
above.

- If female, participant must meet the criteria for Contraception Recommendations.

- Female participants of childbearing potential must have a negative serum pregnancy
test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit
prior to study drug dosing.

Exclusion Criteria:

- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Participant with disease limited to the rectum (ulcerative proctitis) during the
Screening endoscopy.

- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
days prior to Baseline.

- Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.

- Received intravenous corticosteroids within 14 days prior to Screening or during the
Screening Period.

- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g.,
tofacitinib, baricitinib, filgotinib, upadacitinib).

- Screening laboratory and other analyses show any abnormal results.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 2X8
Edmonton - T5R 1W2
Kelowna - V1Y 1Z9
Victoria - V8V 3M9
Hamilton - L8S 4K1
Ottawa - K1H 8L6
Sudbury - P3A 1W8
Vaughan - L4L 4Y7
Greenfield Park - J4V 2H1
Levis - G6V 3Z1
Montreal - H1M 1B1
Montreal - H4A 3J1
Montreal - H2X 0A9
Sherbrooke - J1G 2E8