Bollinger Ingerheim's first phase II clinical trial in research immunologic preparations
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Last Update: 2020-05-13
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Source: Internet
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Author: User
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Medical Network May 13 hearing Boehringer Ingelheim announced that, based on the research of new drugs Spesolimab immune positive results in Phase I clinical trials of generalized pustular psoriasis indications, its global pivotal Phase II clinical trial has started, and in Huashan hospital Dermatology successfully enrolled the first patient in ChinaSpesolimab IL-36R is a monoclonal antibody can be blocked by receptor Interleukin -36 (IL-36R) effectBoehringer Ingelheim indication of the drug being developed in a variety of immunologicalcomprises pustular psoriasis, including theThis is the second biological agents Boehringer Ingelheim developed in the field of immunology, but also its first independently developed immune disease agentsInterleukin -36 receptor signaling pathway is an immune system, it can play a role in many inflammatory diseases, including including the GPPIt is an investigational new drug Spesolimab IL-36R monoclonal antibody, Boehringer Ingelheim is one of the first antibody used in this field of dermatology companyResults of clinical trialsSpesolimab of Phase I in March 2019 published in the "New England Journal of Medicine" (NEJM)Data show that, Spesolimab as the first of its kind in the research of treatment, significantly improved generalized pustular psoriasis: 7 patients experienced moderate to severe acute onset of the disease after using Spesolimab, has been rapid improvement in symptomsIn this phase I clinical trial for a period of 20 weeks, the seven patients in five people in the first week after a single dose treatment will reach the skin clear or nearly clear, the other 4 patients Zhou also achieve the same effectIn the first four weeks, the average level of improvement in skin symptoms in patients with close to 80%, and maintained until the end of the study (20 weeks)the Phase I trial experience into the first of its kind is acute, severe pustular psoriasis trial attack patientsGiven the enormous potential of Spesolimab, Boehringer Ingelheim started a global Phase II clinical trialsThanks to Boehringer Ingelheim launched late last year, China will be fully integrated into the world early clinical development program, "China key" project, China's participation in the global clinical trials, and become one of the key sitesthe Phase II clinical trials led by a Fudan Huashan, to assess the effectiveness in treating patients Spesolimab pustular psoriasis occurs in severe acute episodes (GPP) of and securityPhase IIb clinical trials conducted over the same period, led by the Second Affiliated Hospital of Zhejiang University, will assess Spesolimab in seizures in patients efficacy and safety prevention of generalized pustular psoriasis (GPP) historyIn addition, patients enrolled in two clinical trials will have the opportunity to enter the subsequent clinical trials and open-label treatment continued for up to five yearsFollowing Huashan Hospital and the Second Affiliated Hospital of Zhejiang University started the clinical trial will be well-known top three hospitals in Beijing, Guangzhou, Tianjin, Hangzhou, Dalian, Shenyang, Chengdu and other places expand(Original cut there)
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