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

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04195698

Run by

AbbVie

People needed

475

Starts

2020-01-15

Expected to finish

2023-09-11

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Duplicate_First OC Dermatology Research Inc /ID# 218619 — Fountain Valley, California, United States
• UCSF Fresno /ID# 218453 — Fresno, California, United States
• California Allergy and Asthma Medical Group /ID# 218635 — Los Angeles, California, United States
• Dermatology Research Associates /ID# 218637 — Los Angeles, California, United States
• Dermatology Clinical Trials /ID# 218627 — Newport Beach, California, United States
• Duplicate_UC Davis Health /ID# 218582 — Sacramento, California, United States
• Ucsd /Id# 218629 — San Diego, California, United States
• Clinical Science Institute /ID# 218632 — Santa Monica, California, United States
• Miami Dermatology and Laser Institute /ID# 218664 — Miami, Florida, United States
• Florida International Rsrch cr /ID# 218663 — Miami, Florida, United States
• GCP Research /ID# 218665 — St. Petersburg, Florida, United States
• Clinical Research Trials of Florida, Inc. /ID# 218438 — Tampa, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc /ID# 218441 — Albany, Georgia, United States
• Medical Dermatology Associates of Chicago /ID# 218551 — Chicago, Illinois, United States
• Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552 — Normal, Illinois, United States
• Dawes Fretzin, LLC /ID# 218478 — Indianapolis, Indiana, United States
• Beacon Clinical Research, LLC /ID# 218636 — Quincy, Massachusetts, United States
• Duplicate_Michigan Center for Research Company /ID# 218577 — Clarkston, Michigan, United States
• Henry Ford Medical Center - New Center One /ID# 218575 — Detroit, Michigan, United States
• Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548 — Lincoln, Nebraska, United States
• Skin Specialists, PC /ID# 218549 — Omaha, Nebraska, United States
• University Hospitals Case Medical Center /ID# 218574 — Cleveland, Ohio, United States
• Southside Dermatology /ID# 218477 — Tulsa, Oklahoma, United States
• Oregon Medical Research Center /ID# 218440 — Portland, Oregon, United States
• University of Arkansas for Medical Sciences /ID# 221021 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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