To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaq… (NCT07008547) | Clinical Trial Compass
CompletedPhase 3
To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis
China202 participantsStarted 2024-07-30
Plain-language summary
The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with moderate to severe plaque psoriasis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat plaque psoriasis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must voluntarily sign and date an Informed Consent Form (ICF) approved by the Ethics Committee (IEC) prior to any study-related procedures. The legal representative may also be asked to sign the ICF in accordance with local laws and regulations if necessary.
* Male or female, ≥ 18 years old at the time of signing the ICF.
* Patients with plaque psoriasis diagnosed at least for 6 months prior to signing the ICF.
* Patients who have inadequate response or intolerance to phototherapy or systemic drug therapy (biological or non-biological agents other than IL-17/IL-17R inhibitors) for psoriasis, or meet the above treatment indications in the opinion of the investigator.
* Patients with psoriasis involved body surface area (BSA) of 10% or more, PASI score of 10 or more, and sPGA score of 3 or more at screening.
* WOCBP have a negative serum pregnancy test (no pregnancy test is required for women of non-childbearing potential).
* Patients of childbearing potential and their partners must implement reliable contraceptive measures as specified in the protocol from signing the ICF until 20 weeks after the last dose of study treatment (see Appendix 10 for details).
* Patients who have the ability to follow protocol procedures as judged by the investigator.
Exclusion Criteria:
* Patients with other types of psoriasis (e.g., erythrodermic psoriasis, pustular psoriasis, guttate psoriasis) or any other skin disorders (e.g., eczema) that may affect the trea…