NCT04159597

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
Last Updated

January 30, 2026

Status Verified

April 1, 2025

First QC Date

November 7, 2019

Last Update Submit

January 29, 2026

Conditions

Keywords

Expanded AccessPre-approval AccessCompassionate UseSpecial Access ProgramNamed Patient BasisSpecial Access Scheme

Interventions

Upadacitinib will be administered as oral solution.

Also known as: ABT-494, Rinvoq, C25-267

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • There are other suitable treatment options.
  • The participant qualifies for ongoing clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeDermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 12, 2019

Last Updated

January 30, 2026

Record last verified: 2025-04