drugset / Trial / NCT06398652

Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis

NCT06398652

Phase 3 Completed 336 enrolled Taizhou Mabtech Pharmaceutical Co.,Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-08-27
Primary completion
2025-06-30
Completion
2026-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject CMAB015 Unknown 300 mg Subcutaneous
Comparator Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications