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

NCT06398652 | Completed Phase 3

• 1 other identifier: CMAB015-002
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with PASI 75 at week 12.

  The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI scores compared with the Baseline PASI scores.

  week 12

Secondary Outcomes (16)

• Proportion of patients with IGA (mod 2011) 0/1 at week 12.

  week 12

• Proportion of patients with IGA (mod 2011) 0/1 at week 52.

  week 52

• Proportion of patients with IGA (mod 2011) 0 at week 12.

  week 12

• Proportion of patients with IGA (mod 2011) 0 at week 52.

  week 52

• Proportion of patients with PASI 50 at week 12.

  week 12

Other Outcomes (7)

• AUC0-t

  week 52

• AUC0-inf

  week 52

• Half time

  week 52

Study Arms (2)

Experimental Arm

EXPERIMENTAL

CMAB015

Biological: CMAB015

Active Comparator Arm

ACTIVE COMPARATOR

Secukinumab

Biological: Secukinumab

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.

Experimental Arm

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.

Also known as: Cosentyx

Active Comparator Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of confirmed moderate-severe plaque psoriasis for at least 6 months before randomization.
• PASI scores≥12, IGA (mod 2011) scores ≥3 and BSA≥10% at screening and randomization.
• With indications for phototherapy or systemic therapy.
• Voluntarily sign informed consent.

You may not qualify if:

• Presented with pustular psoriasis, erythrodermic psoriasis，guttate psoriasis or psoriasis triggered by medicine at screening.
• Active persistent cutaneous inflammatory disease other than psoriasis at randomization.
• Treatment with phototherapy, including but not limited to ultraviolet A phototherapy (with or without psoralen), ultraviolet B phototherapy, or excimer laser within 4 weeks prior to randomization. Patients who are unwilling to avoid excessive UV exposure within 4 weeks prior to randomization and during this trial.
• Use of systemic treatment with anti-psoriasis non-biologic agents within 4 weeks prior to randomization, including but not limited to glucocorticoids, retinoids, cyclosporine, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, tofacitinib, apremilast, traditional Chinese medicine/proprietary Chinese medicine, etc.
• Intra-articular glucocorticoid injection within 4 weeks or 5 drug half-lives (whichever is longer) prior to randomization.
• Topical anti-psoriasis treatment within 2 weeks prior to randomization.
• Prior treatment with the following biologic agents for the treatment of psoriasis within the specified time period prior to randomization: ustekinumab\<6 months, Adalimumab, Etanercept, Infliximab, Golimumab, Guselkumab\<12 weeks, Rituximab\<12 months, or any other biological agent\< 5 half lives.
• Prior treatment with anti-IL-17 antibody or anti-IL-17 receptor antibody.
• Meets any of the following at screening: haemoglobin\<80 g/L, white blood cell\<3×10E9/L, Neutrophils\<1.5×10E9/L, platelet\<75×10E9/L, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBiL)\>2 times the upper limit of normal (ULN), serum creatinine (Scr)\>1.5 ULN.
• History of inflammatory bowel disease or other disease with a high risk of perforation or other active autoimmune disease.
• Systemic infection or serious infection requiring hospitalization and/or intravenous anti-infective therapy within 4 weeks prior to randomization; any active infection within 2 weeks prior to randomization, with the exception of general upper respiratory tract infection.
• Have Received a live vaccine within 12 weeks prior to randomization, or plan to receive a live vaccine during the study or within 6 months after the last dose.
• Previously diagnosed or ongoing lymphoproliferative disorders. Malignant tumors within 5 years prior to screening, excluding squamous cell carcinoma of the skin or basal cell carcinoma or unflavored cervical cancer that have been cured after treatment.
• History of depression and/or any finding of suicidal ideation before randomization.
• Concomitant progressive or uncontrolled cardiovascular and cerebrovascular diseases, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, and neurological diseases, which are judged by the investigators to be inappropriate for participation in this study;

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin h Xu, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: August 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: March 19, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)