CompletedPhase 3

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

China336 participantsStarted 2024-08-27

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Proportion of patients with PASI 75 at week 12.

Timeframe: week 12

Trial details

NCT IDNCT06398652

SponsorTaizhou Mabtech Pharmaceutical Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30