U-Accomplish

A Study of the Efficacy and Safety of an Active Drug in Participants With Moderately to Severely Active Ulcerative Colitis

Brief summary

The objective of this study is to evaluate the efficacy and safety of an active drug compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Interventional study

Status:
Recruiting
Conditions:
Ulcerative Colitis (UC)
Enrollment:
462 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-675
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:

- Male or female participants >= 16 and <=75 years of age at Baseline

- 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 authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh >=40 kilograms
and meet the definition of Tanner Stage 5 at the Screening Visit.

- Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to
3.

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

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 as defined above.

- 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.

- If female, participant must meet the contraception recommendation criteria.

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 who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic
results.

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T5R 1W2

Edmonton - T6L 6K3

Victoria - V8V 3M9

Vaughan - L4L 4Y7

Montreal - H2X 0A9

Sherbrooke - J1G 2E8

Fredericton - E3B 5N5

St. John - E2K 1J5

British Columbia

New Brunswick

Ontario