This study is in progress, not accepting new patients

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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Jonathan Terdiman (ucsf)
Headshot of Jonathan Terdiman
Jonathan Terdiman

Description

Summary

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

Official Title

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

Keywords

Crohn's Disease (CD), Crohn's Disease, Efficacy, Safety, Tolerability, ABT-494, Crohn Disease, Upadacitinib

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC San Diego Health System /ID# 150041
    La Jolla California 92037 United States
  • Univ California, San Francisco /ID# 149987
    San Francisco California 94143-2204 United States

Lead Scientist at University of California Health

  • Jonathan Terdiman (ucsf)
    Dr. Jonathan P. Terdiman is a Professor of Clinical Medicine and Surgery and the Chief of the Gastroenterology Division at UCSF Health. He earned his undergraduate degree from Princeton University in 1985 and his medical degree from the Columbia University College of Physicians and Surgeons in 1989.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT02782663
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 107 people participating
Last Updated