NCT06398652

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

Comparative Study of the Efficacy, Safety, and Immunogenicity of CMAB015 and Secukinumab in Adult Patients With Moderate-severe Chronic Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was a multicenter, randomized, double-blind, secukinumab controlled, 1:1 ratio parallel grouping, equivalent design. The study treatment period would be 52 weeks, including a 12-week induction therapy period and a 40-week maintenance therapy period. The primary endpoint was the proportion of patients achieving at least a 75% improvement in PASI scores from baseline at 12 weeks, with an equivalence cut-off of ±15%. A total of 336 adult patients with moderate-to-severe plaque psoriasis are planned to be enrolled, with 168 cases in each group. Eligible subjects received 300 mg CMAB015 or Secukinumab subcutaneous injection. Patients who do not achieve at least a 50% improvement in PASI scores at week 12 would withdraw from the study, and patients who achieve a 50% improvement continue on maintenance therapy until the last treatment at week 48. This study is a double-blind design, and a central randomization system woud be used to randomize subjects. The control factors for randomization are body weight (\<60 kg, ≥60 kg), prior treatment (prior systemic therapy with no prior biologics, prior systemic therapy with biologics), concomitant psoriatic arthritis (yes, no), and PK intensive sampling (yes, no).

Conditions

• Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-27
• Primary completion: 2025-06-30
• Completion: 2026-03-31
• First posted: 2024-05-03
• Last updated: 2025-09-10

Locations

1 site across 1 country: China