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

NCT06398652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jin h Xu, PhD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398652 on ClinicalTrials.gov