M19-850 - Upadacitinib AD Ph 3 extension study
Research type
Research Study
Full title
A phase 3b, open label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study
IRAS ID
270111
Contact name
Mahreen Ameen
Contact email
Eudract number
2019-001227-12
Duration of Study in the UK
1 years, 6 months, 15 days
Research 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.
This is a Phase 3b, open-label, single arm treatment extension study for adult (18-75 years) patients with moderate to severe AD who have successfully completed treatment in the M16-046 study.
Patients will receive upadacitinib for a duration of 52 weeks in M19-850 study.
Upadacitinib is an investigational drug currently being developed for the treatment of AD. This study will evaluate how well upadacitinib works long-term to treat atopic dermatitis and how safe it is.
The study is open label which means that the patient and the Study Doctor will know what treatment regimen the patient is receiving.
The study consists of a Baseline visit (week 24 [last on-treatment visit] of M16-046 study), a 52-week open-label treatment period, followed by an End-of-Study Follow-Up Visit (or phone call if a visit is not possible) 30 days after the last dose of upadacitinib.
Approximately 300 patients will be enrolled in the study in approximately 55 sites worldwide.
Patients will attend regular study visits at the hospital or clinic. The effect of the treatment on the skin will be checked by dermatologic assessments, blood tests, checking for side effects and completing questionnaires.
Additional optional blood and skin samples will be collected to see why some people respond better than others to the drug. Patients will need to sign a consent form to have these samples collected.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1964
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion