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

Ulcerative Colitis (UC)
1558 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Double (Participant, Investigator)


Eligibility criteria

Participant attributes:
Male and Female


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

- 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

- 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 - T6K 4B2
New Westminster - V3L 3W4
Victoria - V8V 3M9
London - N6A 5W9
North Bay - P1B 2H3
Vaughan - L4L 4Y7
Lévis - G6V 3Z1
Montreal - H1T 2M4
Montreal - H4A 3J1

More information about this study