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Completed
NCT07746479
A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis )
Conditions: Psoriasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 244
Sponsor: Livzon Pharmaceutical Group Inc.
Location: Shanghai Dermatology Hospital Shanghai
Summary
This study is a Multicenter, Open-Label, Single-Arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of LZM012 Injection in Patients With Moderate to Severe Plaque Psoriasis.
Eligibility Criteria
Inclusion Criteria:
1. Aged ≥18 years at screening, male or female.
2. History of psoriasis for ≥6 months prior to screening, diagnosed as plaque psoriasis according to the Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition) at screening, and considered by the investigator to be suitable for systemic therapy.
3. Meeting all three of the following criteria at screening:
(A)PASI score ≥10;
(B)sPGA score ≥3;
(C)BSA ≥10%.
4. Female participants of childbearing potential must agree to have no pregnancy or egg donation from the time of signing the informed consent form to the end of the study, and voluntarily use highly effective contraceptive measures, except for postmenopausal women; male participants must agree to have no pregnancy (of partner) or sperm donation from the time of signing the informed consent form to the end of the study, and voluntarily use highly effective contraceptive measures. Menopause is defined as meeting one of the following: a) history of bilateral oophorectomy or hysterectomy; b) age ≥55 years, with amenorrhea for ≥12 months without other pathological or physiological reasons; c) age \
Source: ClinicalTrials.gov (NCT07746479). StuddyBuddy aggregates publicly available trial information.