ClinicalTrials.gg
CompletedNCT07746479Updated Aug 5, 2026

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

A Phase 3 interventional study of LZM012 in Psoriasis, sponsored by Livzon Pharmaceutical Group Inc.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Livzon Pharmaceutical Group Inc. (part of Joincare Pharmaceutical Group Industry Co., Ltd.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2025, registered Jul 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
244
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 244 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Livzon Pharmaceutical Group Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

First submitted after Livzon Pharmaceutical Group Inc. became part of Joincare Pharmaceutical Group Industry Co., Ltd..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 must agree to have no pregnancy or egg donation from the time of signing the form to the end of the study, and voluntarily use highly effective measures, except for 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.
  5. Ability to understand and comply with the protocol requirements, and voluntary participation in the clinical trial.

Exclusion criteria

Exclusion Criteria:

  1. History of severe allergic reaction to biological agents, or previous history of severe drug allergy.
  2. Presence of inflammation, ulceration, induration, scar, mass, or other conditions at the injection site that, in the investigator's opinion, preclude subcutaneous injection administration.
  3. 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).
  4. 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.
  5. 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.

  6. History of severe immunodeficiency, including: positive (HIV) antibody, or other acquired or congenital immunodeficiency diseases.
  7. Presence of any of the following conditions:

    (A)History of chronic congestive heart failure with Class IV; history of echocardiographic cardiac (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 showing ≥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;

    (F)History of severe psychiatric disorders such as depression, schizophrenia, schizoaffective disorder, or history of suicidal ideation or suicidal behavior;

    (G)History of severe neurological disorders such as stroke or epilepsy;

    (H)Active bleeding disorders of internal organs, or severe bleeding tendency (e.g., hemophilia);

    (I)Other progressive or uncontrolled systemic diseases that, in the investigator's assessment, may be unstable or may become severe during the trial, making the subject unsuitable for participation.

  8. 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.).
  9. History of cancer within 5 years prior to screening, except for cured cutaneous basal cell carcinoma or Stage I squamous cell carcinoma.
  10. History of alcohol abuse (defined as consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine) or history of illicit drug use within 1 year prior to screening.
  11. Presence of active diseases other than psoriasis or psoriatic arthritis (e.g., inflammatory bowel disease, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, inflammatory myopathies, mixed connective tissue disease, overlap syndrome, etc.).
  12. Use of topical anti-psoriatic drugs or physical therapy within 2 weeks prior to screening (see prohibited medications/therapies for details).
  13. Use of systemic anti-psoriatic drugs other than biologics within 4 weeks prior to screening (see prohibited medications for details).
  14. Use of TNF-α inhibitors, IL-12/23 inhibitors, IL-23 inhibitors, or IL-17 inhibitors within 3 months or 5 half-lives (whichever is longer) prior to screening (see prohibited medications for details).
  15. Previous participation in and receipt of study drug in the LZM012 clinical trial.
  16. Participation in any clinical trial of an drug (defined as having received study drug) within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
  17. Any of the following laboratory results at screening:

    (A)Hematology: (HGB) \<90 g/L; count (PLT) \<100 × 10⁹/L; white blood cell count (WBC) \<3 × 10⁹/L; (NEUT) \<1.5 × 10⁹/L;

    (B)Liver function: (ALT) or aspartate aminotransferase (AST) >3 times the (ULN), or total >1.5 times ULN;

    (C)Renal function: serum creatinine >1.5 times ULN.

  18. Receipt of a (including attenuated live vaccine) within 3 months prior to screening, or planned receipt of a live vaccine (including attenuated live vaccine) during the trial.
  19. Meeting any of the following at screening:

    (A)Positive surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with further testing showing HBV-DNA ≥500 IU/mL;

    (B)Positive virus (HCV) antibody with further testing showing HCV RNA positive;

    (C)Positive syphilis specific antibody with further testing showing positive syphilis non-specific antibody (including but not limited to rapid plasma reagin (RPR) test, toluidine red unheated serum test (TRUST), etc.).

  20. Pregnant or breastfeeding women, or positive pregnancy test result at screening.
  21. Any other condition or situation that, in the investigator's opinion, makes the subject unsuitable for participation in this trial.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
244 participants (actual)

Study arms

  • Experimental
    LZM012 Monotherapy Group

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

    Biological: LZM012

Interventions

  • BiologicalLZM012

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

06

What researchers measure

Primary outcomes

  1. PASI100 response rate

    The ratio of patients reached PASI100 (PASI100 response rate)

    Time frame: At week 12

Secondary outcomes

  1. Time to first achievement of PASI50, PASI75, PASI90 and PASI100

    Time frame: Up to Week 12

  2. PASI75/PASI90 response rate

    Time frame: At week 4、 At week 8、 At week 12

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

    Time frame: at Week 4, Week 8, Week 12

  4. sPGA 0/1 response rate

    Time frame: At week 4、 At week 8、 At week 12

  5. change in Dermatology Life Quality Index (DLQI) score

    Dermatology Life Quality Index (DLQI) Score range: 0 to 30; higher scores indicate worse health-related quality of life.

    Time frame: At week 4、 At week 8、 At week 12

  6. treatment-emergent adverse events

    Time frame: up to week 16

  7. Vital signs: systolic blood pressure

    Time frame: Up to Week 16

  8. Vital signs: diastolic blood pressure

    Time frame: Up to Week 16

  9. Vital signs: pulse rate

    Time frame: up to week 16

  10. Vital signs: tympanic temperature

    Time frame: up to week 16

  11. Electrocardiogram (ECG): PR interval, QT interval

    Time frame: Up to Week 16

  12. Electrocardiogram (ECG): heart rate

    Time frame: up to week 16

  13. physical examinatio: Proportion of subjects with abnormal skin findings on physical examination

    Time frame: Up to Week 16

  14. physical examination:Proportion of subjects with abnormal head and neck findings on physical examination

    Time frame: up to week 16

  15. physical examination:Proportion of subjects with abnormal chest findings on physical examination

    Time frame: up to week 16

  16. physical examination:Proportion of subjects with abnormal abdomen findings on physical examination

    Time frame: up to week 16

  17. physical examination:Proportion of subjects with abnormal extremities findings on physical examination

    Time frame: up to week 16

  18. Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) positive

    Time frame: From baseline to Week 12

  19. Laboratory tests: hematology:Platelet count, Neutrophil count, Lymphocyte count, White blood cell (WBC) count

    Time frame: up to week 16

  20. Laboratory tests: hematology:Hemoglobin (Hb)

    Time frame: up to week 16

  21. Laboratory tests: hematology:Hematocrit (Hct), Neutrophil percentage

    Time frame: up to week 16

  22. Laboratory tests: serum biochemistry:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Creatine phosphokinase (CPK)

    Time frame: up to week 16

  23. Laboratory tests: serum biochemistry:Total bilirubin (TBIL), Direct bilirubin (DBIL), Creatinine (Cr), Uric acid (UA);

    Time frame: up to week 16

  24. Laboratory tests: serum biochemistry:Total cholesterol (TC), Triglycerides (TG), Low-density lipoprotein cholesterol (LDL-C), Glucose (GLU)

    Time frame: up to week 16

  25. Laboratory tests: urinalysis:Urine protein, urine glucose, urine ketone bodies;

    Time frame: up to week 16

  26. Laboratory tests: urinalysis:Urine leukocytes, urine erythrocytes

    Time frame: up to week 16

07

Study locations

1 site
  • Shanghai Dermatology Hospital
    Shanghai, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Jan 2026, 7 months.

Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 7 months is below that.

Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Aug 5, 2026
StartActual
Jun 23, 2025
Primary completionActual
Jan 26, 2026
CompletionActual
Jan 26, 2026
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07746479
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Jun 23, 2025
Primary completion
Jan 26, 2026
Completion
Jan 26, 2026
Last update
Aug 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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