A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

AbbVie

Status and phase: Active, not recruiting; Phase 2

Conditions: Crohn's Disease (CD)

Treatments: Drug: ABT-494

Study type: Interventional

Funder types: Industry

Identifiers

NCT02782663

2015-003759-23 (EudraCT Number)

M14-327

Details and patient eligibility

About

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Enrollment: 107 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have completed Study M13-740 through Week 52.
• If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion criteria

• For any reason participant is considered by the investigator to be an unsuitable candidate
• Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
• Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Upadacitinib (ABT-494) Dose A

Experimental group

Description:

Open label dose A once daily (QD)

Treatment:

Drug: ABT-494

Upadacitinib (ABT-494) Dose B

Experimental group

Description:

Open label dose B QD

Treatment:

Drug: ABT-494