NCT04195698

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

Brief 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.

Interventional

Interventional study

Status:
Completed
Conditions:
Atopic Dermatitis
Enrollment:
485 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-850
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

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.

All the cities where the clinical studies are located

Calgary - T2G 1B1
Calgary - T2J 7E1

More information about this study

clinicaltrials.gov