NEW YORK, Aug. 11, 2020 /PRNewswire/ — Galderma have announced the start of patient recruitment for the ARCADIA studies (NCT03985943, NCT03989349, NCT03989206), a clinical research program to evaluate an investigational drug in people who have been diagnosed with moderate-to-severe atopic dermatitis (also known as AD or eczema).
AD is a chronic itchy inflammatory skin disease estimated to occur in 10% to 20% of the population, and up to 25% of children. AD can have a serious impact on a person’s quality of life, and for many adolescents and adults living with moderate-to-severe AD, medications that are currently available may not fully control their symptoms.
School can often represent a particular challenge for affected children and adolescents where they may sometimes feel different, self-conscious or anxious about fitting in. The ARCADIA study is still recruiting and, as minds begin to turn to the start of a new school term, anyone who has been living with moderate-to-severe AD, or knows someone who has, are encouraged to visit the study website: www.ArcadiaStudy.com to learn more about the ARCADIA studies and to find out more about eligibility.
While the exact cause of AD is still not fully understood, researchers do know that there are multiple factors involving complex interactions between our genes, immunological factors, infections and environmental factors. It is characterised by an allergic response driven by a subset of immune cells called Type 2 helper T cells. IL-31, a cytokine released by these T cells is thought to play a role in AD skin inflammation, itch and barrier impairment.
There are a number of topical and systemic treatments available for those living with moderate-to-severe AD, however their long-term use can either cause unwanted side-effects or their safety in long-term use has not been established.
Dr. Jonathan Silverberg, MD, PhD, MPH. said: “It is crucial that we continue to research new treatment options for moderate-to-severe atopic dermatitis. We are pleased to support the roll-out of the Arcadia study, as the results have the potential to provide an effective alternative treatment option for those who are living with the significant burden caused by this condition.”
The ARCADIA program, sponsored by Galderma, comprises 2 identical Phase 3 studies evaluating the efficacy and safety of nemolizumab compared to placebo in the treatment of AD, which is not adequately controlled with topical treatments. In addition, there is a 104-week long-term extension safety study.
Phase 2 study results for the use of nemolizumab in the treatment of AD and associated itching showed clinical benefits and provided further evidence that IL-31 may be an important factor in AD.
Up to 1500 people in approximately 300 study centers across Europe, North America and the Asia Pacific are expected to take part in this study.
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31R alpha, which blocks signalling from IL-31. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.
About the ARCADIA Studies
ARCADIA 1 & 2 are identical Phase 3 randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of nemolizumab (CD14152) in subjects with moderate-to-severe atopic dermatitis. The primary objective of the ARCADIA studies is to evaluate the efficacy and safety of the nemolizumab compared to placebo after 16 weeks of treatment in both adult and adolescents (aged 12 to 17) with AD, which is not adequately controlled by topical treatments. The studies will also be evaluating the efficacy and safety of maintenance treatment with nemolizumab for up to an additional 32 weeks. ARCADIA LTE is a 104-week open-label safety extension study.
SOURCE Galderma ARCADIA clinical studies