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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04195698

Public ClinicalTrials.gov record NCT04195698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 6, 2026, 11:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04195698
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
475 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 15, 2020 (Actual)
Primary completion
Sep 11, 2023 (Actual)
Completion
Sep 11, 2023 (Actual)
Last update posted
Jan 9, 2025

2020 – 2023

United States locations

U.S. sites
33
U.S. states
18
U.S. cities
30
Facility City State ZIP Site status
University of Arkansas for Medical Sciences /ID# 221021 Little Rock Arkansas 72205 —
Duplicate_First OC Dermatology Research Inc /ID# 218619 Fountain Valley California 92708-3701 —
UCSF Fresno /ID# 218453 Fresno California 93701-2302 —
California Allergy and Asthma Medical Group /ID# 218635 Los Angeles California 90025-7014 —
Dermatology Research Associates /ID# 218637 Los Angeles California 90045 —
Dermatology Clinical Trials /ID# 218627 Newport Beach California 92660-7853 —
Duplicate_UC Davis Health /ID# 218582 Sacramento California 95816-3300 —
Ucsd /Id# 218629 San Diego California 92103 —
Clinical Science Institute /ID# 218632 Santa Monica California 90404-2102 —
Miami Dermatology and Laser Institute /ID# 218664 Miami Florida 33173-3570 —
Florida International Rsrch cr /ID# 218663 Miami Florida 33173 —
GCP Research /ID# 218665 St. Petersburg Florida 33705 —
Clinical Research Trials of Florida, Inc. /ID# 218438 Tampa Florida 33607 —
Georgia Pollens Clinical Research Centers, Inc /ID# 218441 Albany Georgia 31707-1282 —
Medical Dermatology Associates of Chicago /ID# 218551 Chicago Illinois 60654-6903 —
Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552 Normal Illinois 61761 —
Dawes Fretzin, LLC /ID# 218478 Indianapolis Indiana 46256 —
Beacon Clinical Research, LLC /ID# 218636 Quincy Massachusetts 02169 —
Duplicate_Michigan Center for Research Company /ID# 218577 Clarkston Michigan 48346 —
Henry Ford Medical Center - New Center One /ID# 218575 Detroit Michigan 48202-3046 —
Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548 Lincoln Nebraska 68505-2343 —
Skin Specialists, PC /ID# 218549 Omaha Nebraska 68144 —
University Hospitals Case Medical Center /ID# 218574 Cleveland Ohio 44106 —
Southside Dermatology /ID# 218477 Tulsa Oklahoma 74132 —
Oregon Medical Research Center /ID# 218440 Portland Oregon 97223 —
Oregon Medical Research Center /ID# 218578 Portland Oregon 97239 —
Duplicate_Medical University of South Carolina /ID# 221072 Charleston South Carolina 29425 —
Clinical Research Solutions, LLC /ID# 218447 Jackson Tennessee 38305-2163 —
Orion Clinical Research /ID# 218565 Austin Texas 78759-4100 —
Sante Clinical Research /ID# 218911 Kerrville Texas 78028-9640 —
Clinical Research Partners, LLC /ID# 218480 Richmond Virginia 23220-4459 —
Duplicate_Premier Clinical Research /ID# 218583 Spokane Washington 99202 —
West Virginia Research Inst /ID# 218479 South Charleston West Virginia 25309 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 83 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04195698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 9, 2025 · Synced Oct 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04195698 live on ClinicalTrials.gov.

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