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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04195698

2019-001227-12 (EudraCT Number)

M19-850

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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475 participants in 1 patient group

Upadacitinib

Experimental group

Description:

Participants will be administered with upadacitinib once daily (QD)

Treatment:

Drug: Upadacitinib