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

Phase 1

Conditions: Crohn's Disease (CD)
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-001225-41-AT

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 906

Inclusion Criteria

For Substudy 1:
- Subject who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
- Subject completes Week 12 or Week 24 study procedures in study M14-431 or study M14-433. The final endoscopy for studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.

For Substudy 2:
- Subject completes Substudy 1 of Study M14-430. The week 52 endoscopy may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- Subject achieved clinical response at Week 24 and completed Week 24 visit and procedures in Part 3/Cohort 3 of Study M14-431.

For Substudy 3
-Subject is an ongoing subject in Substudy 2 for at least 12 months
-Subject has received open-label upadacitinib 30 mg QD for at least 6
months during Substudy 2
-Subject is in stable remission for at least 6 months defined as:
a.CDAI < 150 AND
b.CRP < 5 mg/L and FCP < 250 mg/kg AND
c.Subject has not been on locally acting (rectal or suppository) or
systemic corticosteroids for CD = 90 days prior to the entry of Substudy 3.

NOTE: Hematocrit for baseline CDAI calculation, CRP, and FCP should be assessed within 4 weeks prior to enrolment to confirm subjects are in stable remission at time of enrolment into the substudy and will serve as Baseline (Week 0) results.
-In the past 3 months the subject has not received any new medication or increase of the dose of current concomitant medication for treatment of CD

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 878
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Substudy 1, 2 and 3
-Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
-Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an AE during Studies M14-431, M14-433, or Substudy 1 or 2 of Study M14-430 that, in the investigator's judgment, makes the subject unsuitable for this study.
-Subjects who anticipate the need for any live vaccine during study participation including at least 30 days (or longer, if required locally after the last dose of study drug.
-Female subjects with a confirmed positive pregnancy test at the final visit in Studies M14-431, M14-433, or Substudy 1 of Study M14-430, or who is considering becoming pregnant during the study.
-Subject is not in compliance with prior and concomitant medication requirements throughout Studies M14-431, M14-433, or Substudy 1 or 2 of Study M14-430 per investigator assessment.
-Subject at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment makes the subject an unsuitable candidate for the study. Subjects 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. -Current evidence of active or untreated latent tuberculosis. -Subjects 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.
-Current or history of malignancy or lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly; except for successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma, and/or localized carcinoma in situ of the cervix.
-Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, 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.
-Laboratory values from the visit immediately prior to the Substudy 1 Week 0 Visit or the Substudy 2 Week 0 Visit (for those subjects enrolling into Cohort 4) meeting the following criteria:
·EJAST or ALT > 3 x upper limit of normal (ULN)
·EJTotal WBC count < 2,000/pL
·EJAbsolute neutrophil count (ANC) < 1,000/pL
·EJPlatelet count < 50,000/pL
·EJAbsolute lymphocyte count < 500/pL
·EJHemoglobin <8 g/dL
-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 in Substudy 3, based on the local
reader score.
-Enrollment in another interventional clinical study while participating in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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