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

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT06398652
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CMAB015 — BIOLOGICAL
    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 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Aug 27, 2024
Status verified
May 2026
Primary completion
Jun 30, 2025
Completion
Mar 19, 2026

Study Design

Enrollment
336 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    CMAB015
  • Active Comparator: Active Comparator Arm
    Secukinumab

Primary Outcome Measure

Proportion of patients with PASI 75 at week 12. [ Time Frame: week 12 ]

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