Phase 3
N=475
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04195698 ↗Enrolled (actual)
475
Serious AEs
5.7%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events — 205; 223; 14; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Upadacitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
205; 223; 14; 17; 12; 18 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI) |
7; 8; 6; 4; 1; 0 | — |
| PRIMARY Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator |
0; 0.8; 0; 0.8; 0; 0.4 | — |
| PRIMARY Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator |
0.4; 0.8; 2.5; 5.5; 0.4; 1.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04195698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.