A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

  • Interventional
  • Recruiting
  • NCT03345823
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

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

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

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.

        For Substudy 2:

         - Participant completes Substudy 1

         - 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).

At a Glance

National Government IDNCT03345823

IRB#IRB18-0573

Lead SponsorAbbVie

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting