To assess long-term safety, tolerability and efficacy of upadacitinib in adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study. Efficacy will be evaluated through Week 52, and safety and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment emergent adverse events (TEAEs), serious adverse events (SAEs),
adverse events (AEs) of special interest (AESI), AEs leading to discontinuation
of study drug; vital signs, laboratory tests, and physical examination
findings.
Secondary outcome
- Change and percent change from Baseline in worst pruritus numerical rating
scale (NRS)
- Change and percent change from Baseline in EASI
- Proportion of subjects achieving EASI 75/90/100
- Evaluation of known and/or novel disease-related or drug-related biomarkers
Background summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching
due to inflammation of the skin. Therapies spread over the skin may not be
enough to control AD in patients who require systemic anti-inflammatory
treatments taken by mouth or injection through the skin or vein.
Study objective
To assess long-term safety, tolerability and efficacy of upadacitinib in adult
subjects with moderate to severe atopic dermatitis who successfully completed
treatment in the M16-046 study. Efficacy will be evaluated through Week 52, and
safety and tolerability of upadacitinib will be evaluated until the end of the
study.
Study design
Open label, single group assignment.
Intervention
The study consists of a baseline visit (Week 24 [last on-treatment visit] of
M16-046 study)and a 52-week open-label treatment period. The treatment period
can be extended until regulatory approval and/or applicable local reimbursement
approval of the study drug. At the end of the study a follow-up visit (or phone
call if a visit is not possible) will be done 30 days after the last dose of
upadacitinib.
Study burden and risks
The effect of treatment on the disease will be checked by performing
dermatologic assessments, blood tests, checking for side effects, and
completing questionnaires. Safety evaluations will occur throughout the study.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
• Subjects should have successfully completed treatment in the M16-046 study,
without developing any permanent discontinuation criteria.
• Subject 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
M16-046 study 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 subject who is pregnant, breastfeeding, or considering pregnancy
during the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001227-12-NL |
| ClinicalTrials.gov | NCT04195698 |
| CCMO | NL72873.056.20 |