NCT03398148

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of an Active Drug in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Brief summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of an active drug as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate 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 subjects with moderately to severely active UC.

Interventional study

Status:
Recruiting
Conditions:
Ulcerative Colitis (UC)
Enrollment:
720 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-067
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 16 Years to 80 Years.

Inclusion Criteria:

- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally
permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage
5 for development at the Baseline Visit.

- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to
Baseline.

- Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.

- Demonstrated intolerance or inadequate response to conventional therapy and
tofacitinib (not a biologic) and one or more biologic therapies.

- Females must be postmenopausal for more than 1 year or surgically sterile or
practicing specific forms of birth control.

Exclusion Criteria:

- Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel
disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.

- Participant receiving prohibited medications and treatment.

- Extent of inflammatory disease limited to the rectum as assessed by screening
endoscopy.

- Participant with currently known complications of UC (e.g., megacolon).

- No known active Coronavirus Disease - 2019 (COVID-19) infection.

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T5R 1W2

Edmonton - T6L 6K3

New Westminster - V3L 3W4

Victoria - V8V 3M9

Halifax - B3K 6R8

London - N6A 5A5

North Bay - P1B 2H3

Vaughan - L4L 4Y7

Levis - G6V 3Z1

Montréal - H1T 2M4

Montréal - H3G 1A4