M16-046 Heads-Up Ph3 adults with Moderate to Severe AD
Research type
Research Study
Full title
A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis.
IRAS ID
259483
Contact name
Varvara Kontomina
Contact email
Eudract number
2018-002264-57
Duration of Study in the UK
1 years, 7 months, 4 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 study for adult (18-75 years) patients with moderate to severe AD who are candidates for systemic treatment. Patients will receive treatment with upadacitinib or dupilumab and the placebo (an inactive substance) of the other agent.
Upadacitinib is an investigational drug currently being developed for the treatment of AD. This study will evaluate how well upadacitinib compared to dupilumab (a licensed drug) works to treat atopic dermatitis and how safe it is.
The study is double-blinded which means neither the patient nor the study Doctor will know what treatment regimen has been assigned. Only the unblinded administrator assigned on site will know what treatment the patient is receiving.
The study consists of a 35-day screening period, a 24-week double-blind treatment period, followed by an end-of-treatment Follow-up visit 12 weeks after the last injection. Patients who complete the M16-046 study will have the option to enroll into an open-label study of upadacitinib.
Approximately 650 patients will be enrolled in the study in approximately 160 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 are additional optional biosamples 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 - City & East Research Ethics Committee
REC reference
19/LO/0496
Date of REC Opinion
10 Jun 2019
REC opinion
Further Information Favourable Opinion