Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis - Trial NCT06398652
Access comprehensive clinical trial information for NCT06398652 through Pure Global AI's free database. This Phase 3 trial is sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd and is currently Not yet recruiting. The study focuses on Psoriasis. Target enrollment is 336 participants.
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Study Focus
Sponsor & Location
Taizhou Mabtech Pharmaceutical Co.,Ltd
Timeline & Enrollment
Phase 3
May 31, 2024
Dec 31, 2025
Primary Outcome
Proportion of patients with PASI 75 at week 12.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06398652
Non-Device Trial