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Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis
Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
Summary
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.
Official title: Comparative Study of the Efficacy, Safety, and Immunogenicity of CMAB015 and Secukinumab in Adult Patients With Moderate-severe Chronic Plaque Psoriasis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2024-08-27
Completion Date
2026-03-31
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
CMAB015
Patients would receive 300 mg CMAB007 subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg CMAB007 subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48.
Secukinumab
Patients would receive 300 mg secukinumab subcutaneous injections at week 0, 1, 2, 3, 4, 8 as induction therapy. Patients who obtain a 75% improvement relative to baseline in PASI scores would receive 300 mg secukinumab subcutaneous injections every 4 weeks as maintain therapy, until the last treatment at week 48.
Locations (1)
Huashan Hospital
Shanghai, China