NCT03345823

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of an Active Drug in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Brief summary

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of an active drug, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Interventional study

Status:
Enrolling by invitation
Conditions:
Crohn's Disease
Enrollment:
747 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-430
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 18 Years to 75 Years.

Inclusion Criteria:

For Substudy 1:

- Participant who receive double-blind treatment in Study M14-431 or Study M14-433 and
achieve clinical response.

- Participant completes study procedures in the parent study. The final endoscopy for
Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during
the COVID-19 pandemic.

For Substudy 2:

- Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the
endoscopy cannot be performed during the COVID-19 pandemic.

- Participant who receive open-label upadacitinib Dose B in Study M14-431 and achieve
clinical response.

- Participant completes study procedures in the parent study/substudy.

Exclusion Criteria:

For Sub-studies 1 and 2:

- Participant is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.

- Participant who has a known hypersensitivity to upadacitinib or its excipients, or had
an adverse event during Studies M14-431 and M14-433 or Substudy 1 of Study M14-430
that in the investigator's judgment makes the subject unsuitable for this study.

- Participant with any active or chronic recurring infections based on the
investigator's assessment that makes the subject an unsuitable candidate for the
study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT
dosed until the infection treatment has been completed and the infection is cured,
based on the investigator's assessment.

- Participants with high grade colonic dysplasia or malignancy diagnosed at the
endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of
Study M14-430 (Week 52).

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T5R 1W2

Edmonton - T6G 2X8

Edmonton - T6L 6K3

New Westminster - V3L 3W4

Vancouver - V6Z 2K5

Halifax - B3H 2Y9

North Bay - P1B 2H3

Oshawa - L1H 7K4

Ottawa - K1H 8L6

Sudbury - P3E 5M4

Vaughan - L4L 4Y7

Levis - G6V 3Z1

Montreal - H2X 0A9

Montréal - H3G 1A4

Sherbrooke - J1G 2E8