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NCT02782663

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

Completed Phase 2 Last updated 31 July 2025
What this trial tests

Phase 2 trial testing ABT-494 in Crohn's Disease (CD) in 107 participants. Completed in 18 July 2025.

Timeline
18 May 2016
Primary endpoint
18 July 2025
18 July 2025

Quick facts

Lead sponsorAbbVie
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment107
Start date18 May 2016
Primary completion18 July 2025
Estimated completion18 July 2025
Sites61 locations across Denmark, France, Italy, Netherlands, New Zealand, Slovakia, Belgium, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 75, any sex, with Crohn's Disease (CD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
    Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
  2. JAK-inhibitors. New players in the field of immune-mediated diseases, beyond rheumatoid arthritis.
    Fragoulis GE, McInnes IB, Siebert S. · · 2019 · cited 223× · PMID 30806709 · DOI 10.1093/rheumatology/key276
  3. Emerging trends in colorectal cancer: Dysregulated signaling pathways (Review).
    Ahmad R, Singh JK, Wunnava A, Al-Obeed O, et al · · 2021 · cited 130× · PMID 33655327 · DOI 10.3892/ijmm.2021.4847
  4. Inflammatory Bowel Disease-Associated Colorectal Cancer: Translational Risks from Mechanisms to Medicines.
    Porter RJ, Arends MJ, Churchhouse AMD, Din S. · · 2021 · cited 103× · PMID 34111282 · DOI 10.1093/ecco-jcc/jjab102
  5. Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease.
    Na SY, Moon W. · · 2019 · cited 99× · PMID 31195433 · DOI 10.5009/gnl19019
  6. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
    Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
  7. The Role of Janus Kinase Signaling in Graft-Versus-Host Disease and Graft Versus Leukemia.
    Schroeder MA, Choi J, Staser K, DiPersio JF. · · 2018 · cited 82× · PMID 29289756 · DOI 10.1016/j.bbmt.2017.12.797
  8. The Future of Janus Kinase Inhibitors in Inflammatory Bowel Disease.
    De Vries LCS, Wildenberg ME, De Jonge WJ, D'Haens GR. · · 2017 · cited 82× · PMID 28158411 · DOI 10.1093/ecco-jcc/jjx003

Verify or expand the search:

Other trials of ABT-494

Trials testing the same drug.

Other recruiting trials for Crohn's Disease (CD)

Currently open trials in the same condition.

Other AbbVie trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02782663.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing