Taizhou Mabtech Pharmaceutical Co. Ltd.

This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.

The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis. It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis. The main question it aims to answer is:
In subjects with moderate to severe plate psoriasis treated with CMAB015, Is the proportion of patients achieving a 75% improvement in PASI (Psoriasis area and severity index) scores relative to baseline (PASI 75) the same as those treated with Secukinumab?
Participants will:
Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 48.
Visit the clinic at weeks 0, 1, 2, 3, 4, and 8, followed by every 4 weeks until week 52.
Be evaluated with PASI scores, body surface area (BSA) scores and investigator's global assessment (IGA) (mod 2011) scores.

主要目的： 评价 CMAB015与可善挺®治疗符合系统治疗或光疗指征的中-重度斑块状银屑病成人患者的临床疗效相似性； 次要目的： 评价 CMAB015与可善挺®治疗符合系统治疗或光疗指征的中-重度斑块状银屑病成人患者的安全性、 免疫原性、 药代动力学相似性。