A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis )

NCT07746479 | Completed Phase 3

• 1 other identifier: LZM012-302
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI100 response rate

  The ratio of patients reached PASI100 (PASI100 response rate)

  At week 12

Secondary Outcomes (26)

• Time to first achievement of PASI50, PASI75, PASI90 and PASI100

  Up to Week 12

• PASI75/PASI90 response rate

  At week 4、 At week 8、 At week 12

• Absolute and relative percentage change from baseline in PASI score at each visit

  at Week 4, Week 8, Week 12

• sPGA 0/1 response rate

  At week 4、 At week 8、 At week 12

• change in Dermatology Life Quality Index (DLQI) score

  At week 4、 At week 8、 At week 12

Study Arms (1)

LZM012 Monotherapy Group

EXPERIMENTAL

320mg LZM012 subcutaneous injection every 4 weeks for 3 doses, no dose adjustment permitted.

Biological: LZM012

Interventions

LZM012 BIOLOGICAL

Recombinant anti-human IL-17A/F humanized monoclonal antibody injection

LZM012 Monotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• (A)PASI score ≥10;
• (B)sPGA score ≥3;
• (C)BSA ≥10%.
• 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.

You may not qualify if:

• History of severe allergic reaction to biological agents, or previous history of severe drug allergy.
• 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:
• (A)Diagnosed with active tuberculosis infection, including but not limited to active tuberculosis confirmed by imaging;
• (B)Latent tuberculosis infection or close contact with a tuberculosis patient, except in the following cases: a) confirmed by a specialist that standard treatment for latent tuberculosis infection has been completed within 5 years prior to the first dose; b) prophylactic anti-tuberculosis treatment has been initiated at least 4 weeks before the first dose and the subject is willing to continue prophylaxis according to local guidelines; c) the specialist judges that the risk of progression to active tuberculosis is low and that treatment is not required.
• Latent tuberculosis infection is defined as: positive interferon-gamma release assay (IGRA) at screening, without any clinical signs or symptoms of active tuberculosis. Close contact with a tuberculosis patient is defined as: having had close contact (i.e., spending several days or weeks together in a relatively enclosed space) with a patient with active pulmonary tuberculosis within the past 12 months, or having a family member diagnosed with active tuberculosis infection.
• 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:
• (A)History of chronic congestive heart failure with NYHA Class IV; history of echocardiographic cardiac ejection fraction (EF) below 30%;
• (B)Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months prior to screening; coronary revascularization within 6 months prior to screening;
• (C)History of severe arrhythmias requiring treatment with Class Ia or Class III antiarrhythmic drugs; history of sick sinus syndrome, second-degree type II or third-degree atrioventricular block without an implanted pacemaker;
• (D)Screening ECG showing QTc interval ≥480 ms (Fridericia correction formula, QTc = QT/(RR\^0.33)), or history of prolonged QTc interval and assessed by the investigator as having arrhythmia risk;
• (E)Poorly controlled hypertension within 3 months prior to screening (poorly controlled defined as: blood pressure still not reaching target despite combination therapy with ≥3 antihypertensive agents), or screening systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg confirmed by repeated measurements;

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Shanghai Dermatology Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 5, 2026
• Study Start: June 23, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

CN (1)