A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis ) (NCT07746479) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis )
China244 participantsStarted 2025-06-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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
. Aged ≥18 years at screening, male or female.
. 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.
. Meeting all three of the following criteria at screening:
. 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 \<55 years, with amenorrhea for ≥12 months without other pathological or physiological reasons, and estradiol (E2) \<20 pg/mL or follicle-stimulating hormone (FSH) \>40 mIU/mL.
. Ability to understand and comply with the protocol requirements, and voluntary participation in the clinical trial.
Exclusion criteria
. History of severe allergic reaction to biological agents, or previous history of severe drug allergy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Presence of inflammation, ulceration, induration, scar, mass, or other conditions at the injection site that, in the investigator's opinion, preclude subcutaneous injection administration.
. Presence of other types of psoriasis at screening, including but not limited to erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, drug-induced psoriasis (including new onset or exacerbation of psoriasis caused by β-blockers, non-steroidal anti-inflammatory drugs, antimalarials, interferons, calcium channel blockers, or lithium).
. Presence of severe skin infection, eczema, seborrheic dermatitis, neurodermatitis, or other skin conditions at screening that, in the investigator's assessment, may interfere with the evaluation of psoriasis treatment efficacy.
. Meeting any of the following conditions:
. History of severe immunodeficiency, including: positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases.
. Presence of any of the following clinically significant conditions:
. Meeting either of the following: a) any severe infection within 1 month prior to screening (defined as infection requiring hospitalization or intravenous anti-infective treatment); b) history of opportunistic infections or recurrent, chronic infections that, in the investigator's opinion, could lead to study discontinuation. Opportunistic infections include infections caused by unusual pathogens (e.g., Pneumocystis jirovecii, cryptococcus, etc.) or unusually severe infections caused by common pathogens (e.g., cytomegalovirus, herpes virus, etc.).