NCT03006068

A Study to Evaluate the Long-Term Safety and Efficacy of an Active Drug in Subjects With Ulcerative Colitis (UC)

Brief summary

This study is designed to evaluate the long-term safety and efficacy of an active drug in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

Interventional study

Status:
Enrolling by invitation
Conditions:
Ulcerative Colitis (UC)
Enrollment:
950 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-533
Allocation:
Non-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: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible

- Participant has not achieved clinical response at the end of the induction period
(Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance
period of Study M14-234 Substudy 3, or has successfully completed Study M14-234
Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at
Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2,
M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are
met.

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

- Women of childbearing potential must have a negative urine pregnancy test at Week 0
visit.

- Participant is judged to be in otherwise good health as determined by the principal
investigator based upon clinical evaluations performed during the preceding study
(Study M14-234).

- Must be able and willing to give written informed consent and to comply with the
requirements of this study protocol.

Exclusion Criteria:

- For any reason participant is considered by the investigator to be an unsuitable
candidate.

- Female participant with a positive pregnancy test at the final visit of Study M14-234
or who is considering becoming pregnant during the study or within 30 days after the
last dose of study drug.

- Participant with an active or recurrent infection that based on the investigator's
clinical assessment makes the participant an unsuitable candidate for the study.
Participants with ongoing infections undergoing treatment may be enrolled BUT NOT
dosed until the infection has been successfully treated.

- Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis
and for any reason the participant cannot take full course of TB prophylaxis treatment
as required per protocol.

- Participant with a poorly controlled medical condition, such as uncontrolled diabetes,
unstable ischemic heart disease, moderate or severe congestive heart failure (New York
Heart Association class III or IV), recent cerebrovascular accidents and any other
condition which, in the opinion of the investigator or sponsor, would put the subject
at risk by participation in this study.

- Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of
the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of
Study M14-234.

- History of any malignancy except for successfully treated nonmelanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix from evaluations performed in
Study M14-234.

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T5R 1W2

Edmonton - T6G 2X8

Edmonton - T6L 6K3

Kelowna - V1Y 1Z9

Victoria - V8V 3M9

Hamilton - L8S 4K1

Ottawa - K1H 8L6

Sudbury - P3E 5M4

Vaughan - L4L 4Y7

Greenfield Park - J4V 2H1

Levis - G6V 3Z1

Montreal - H1M 1B1

Montreal - H2X 0A9

Montréal - H3G 1A4

Sherbrooke - J1G 2E8