This study is in progress, not accepting new patients

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Official Title

A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

Keywords

Atopic Dermatitis, Upadacitinib, ABT-494, RINVOQ, Dermatitis, Eczema

Eligibility

You can join if…

Open to people ages 18-75

  • Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
  • Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

You CAN'T join if...

  • Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Locations

  • Ucsd /Id# 218629
    San Diego California 92103 United States
  • Dermatology Clinical Trials /ID# 218627
    Newport Beach California 92660-7853 United States

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
NCT04195698
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 485 study participants
Last Updated