M16-047 Ph3 JAK+TCS subjects with moderate to severe AD
Research type
Research Study
Full title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis
IRAS ID
243522
Contact name
Alun Pinnegar
Contact email
Eudract number
2017-005126-37
Duration of Study in the UK
4 years, 0 months, 0 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 the AD in patients who require systemic anti-inflammatory treatments taken by mouth or injection through the skin or vein.
This is a phase 3 study for adolescent (12-17 years) and adult (18-75 years) patients with moderate to severe AD who are candidates for systemic treatment. Patients will receive treatment with upadacitinib/placebo plus topical corticosteroids (TCS).
Upadacitinib is an investigational drug currently being developed for the treatment of AD. This study will evaluate how well upadacitinib in combination with TCS works within the body and how safe it is compared to placebo (an inactive substance).
The study is double-blinded which means neither the patient nor the study Doctor will know what treatment regimen has been assigned.
The study consists of a 35-day screening period, a 16-week double-blind treatment period, followed by a Blinded Extension Period for total treatment duration of up to 136 weeks, and a 30-day Follow-up Visit.
Approximately 810 patients will be enrolled in the study in approximately 185 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.
There is an additional optional blood test to see why some people respond better than others to the drug. Patients will need to sign a consent form to have this blood sample collected.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1351
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion