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Phase 2 study will test investigational drug in atopic dermatitis
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Novartis, along with biopharmaceutical companies MorphoSys and Galapagos, announced the initiation of GECKO, a phase 2 study exploring a subcutaneous formulation of MOR106 combined with topical corticosteroids in patients with moderate to severe atopic dermatitis.
The study is intended to serve as an investigational new drug opener with the FDA, according to a joint press release from MorphoSys and Galapagos.
The investigational drug, MOR106, is a human monoclonal antibody directed against interleukin-17C.
Patient recruitment will take place in the U.S. and Canada, and the companies aim to randomly assign 60 patients to a dose of MOR106 with topical steroids or subcutaneous placebo for 8 weeks, with a follow-up period of 16 weeks.
The incidence of treatment-emergent adverse and serious adverse events through day 169 is the primary endpoint, whereas secondary endpoints are “pharmacokinetics and the occurrence of anti-drug antibodies” after treatment with MOR106, according to the release.
Clinical trials in Europe are ongoing.
Novartis owns the worldwide and exclusive license for the development and commercialization of MOR106 under an agreement with MorphoSys and Galapagos, which became effective in September 2018.