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:
Active, not recruiting
Conditions:
Crohn's Disease
Enrollment:
747 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-430
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

For Substudy 1:

- Participant who achieve clinical response in Study M14-431 or Study M14-433.

- 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 achieved clincal response at the time descibed in the protocol and
completes study procedures in the parent study/ substudy.

For Substudy 3:

- Participant is an ongoing participant in Substudy 2 for at least 12 months.

- Participant is in stable remission for at least 6 months defined as:

1. CDAI < 150

2. CRP < 5 mg/L and FCP < 250 mg/kg AND

3. Participant has not been on locally acting (rectal or suppository) or systemic
corticosteroids for CD => 90 days prior to the entry of Substudy 3.

Exclusion Criteria:

For Substudies 1,2 and 3:

- 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 or 2 of Study
M14-430 that in the investigator's judgment makes the participant unsuitable for this
study.

- Participant at the final visit of M14-431 or M14-433 with any active or chronic
recurring infections based on the investigator's assessment that makes the participant
an unsuitable candidate for the study. Participants with serious infections undergoing
treatment may be enrolled BUT NOT dosed until the infection treatment has been
completed and the infection is resolved, 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 or 2
of Study M14-430 (Week 52).

For Substudy 3 only:

- Total SES-CD >4 and/or subscore >1 in any segment in the Substudy 2 annual
ileo-colonoscopy, if performed within 6 months prior to Week 0 of Substudy 3.

- Received any new medication or increase of the dose of current concomitant medication
for the treatment of CD in the past 3 months.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
Edmonton - T6G 2X8
Edmonton - T6K 4B2
New Westminster - V3L 3W4
Vancouver - V6Z 2K5
Halifax - B3H 2Y9
London - N6A 5W9
North Bay - P1B 2H3
Oshawa - L1H 7K4
Ottawa - K1H 8L6
Sudbury - P3A 1W8
Vaughan - L4L 4Y7
Lévis - G6V 3Z1
Montreal - H4A 3J1
Montreal - H2X 0A9
Sherbrooke - J1G 2E8

More information about this study

clinicaltrials.gov