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

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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)

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

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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