Comparing CMAB015 and Secukinumab for treating 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

This study is testing whether a new treatment called CMAB015 works as well as Secukinumab for people with moderate to severe plaque psoriasis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd (Industry-sponsored)
• Drugs / interventions: ustekinumab, Adalimumab, Infliximab, Golimumab, Guselkumab, Rituximab, tofacitinib, methotrexate, Secukinumab
• Locations: 1 site (Shanghai)
• Trial ID: NCT06398652 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness and safety of CMAB015 compared to Secukinumab in patients with moderate to severe chronic plaque psoriasis. It involves a multicenter, randomized, double-blind design where participants will receive either treatment through subcutaneous injections over a 52-week period. The primary goal is to determine if the proportion of patients achieving a 75% improvement in PASI scores is equivalent between the two treatments. Participants will be monitored for safety and immunogenicity throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed history of moderate to severe plaque psoriasis and specific PASI and IGA scores.

Not a fit: Patients with other forms of psoriasis or those who have recently undergone certain treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients with moderate to severe plaque psoriasis.

How similar studies have performed: Other studies have shown success with similar biologic treatments for psoriasis, indicating potential for positive outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Positive for any of the followings: hepatitis B virus surface antigen, hepatitis C virus antibody ,human immunodeficiency virus antibody, treponema pallidum antibody.
* Latent or active tuberculosis.
* Allergy to anti-IL-17 antibody active ingredients, excipients or latex.
* Pregnant or nursing women. Male or female patients who are unwilling to use effective contraception during the trial and for 5 months after the last dose
* Participated in other drug clinical trials within 3 months or 5 drug half-lives (whichever is longer) before screening.
* Any major surgery within 8 weeks prior to randomization, or planned major surgery during the study.
* History of recurrent drug abuse or unprescribed medication, or history of alcohol abuse.
* Other conditions judged by the investigator to be inappropriate to participate in this study.

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jin h Xu, PhD — Huashan Hospital
• Study coordinator: Jin h Xu, PhD

Conditions Psoriasis