MOR106-CL-201_Phase II_Atopic Dermatitis_IV MOR106
Research type
Research Study
Full title
A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis.
IRAS ID
236887
Contact name
Michael J. Cork
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2017-001142-10
Clinicaltrials.gov Identifier
GAP1001, CRO Trial code (TFS)
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Atopic dermatitis (atopic eczema) is a chronic itchy inflammatory skin disease that occurs most frequently in children, but also affects adults. The main features of atopic dermatitis (AD) are the impairment of the skin barrier and dysfunction of the immune system accompanied with dry skin and severe itching. In AD the main goals of treatment are improving the appearance of the skin and relieving symptoms. Topical corticosteroids are the most frequently prescribed class of drug but long-term therapy is hampered by risks of skin atrophy, dyspigmentation, acneiform eruptions and risks associated with systemic absorption. Topical calcineurin inhibitors are safe and effective short-term treatments but are also limited long-term by concerns of systemic absorption and subsequent increased risk of malignancies and lymphomas. Repeated application of topical therapies over a long period is both time consuming and inconvenient to patients and their families and leads to poor patient adherence with treatment. Patients with moderate to severe AD that is not controlled with topical therapy may require phototherapy or systemic immunosuppressant treatment to achieve adequate disease control. Oral immunosuppressants and glucocorticoids are also effective as short-term or intermittent therapies. However, long-term use is again restricted by concerns over toxicity and side effects. MOR106, a human monoclonal antibody (IgG1) has significant effects in different skin models of AD and psoriasis. Non-clinical safety studies have demonstrated the absence of any adverse events (AEs) even at the highest dose tested offering beneficial safety margins for testing. The results of a Phase I study have shown that MOR106 is generally well tolerated in healthy male subjects and subjects with moderate to severe AD. To date, it is the first known Interleukin-17C antagonist being evaluated in clinical studies. This Phase II study will be a randomised, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK /pharmacodynamics (PD) of intravenously administered MOR106 in subjects with moderate to severe AD.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0113
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion