PsoriasisPhase 3NCT07746479
A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis )
A Phase 3 study testing LZM012 in people with Psoriasis, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- LZM012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 26 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 39Show fewer
- (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;
- (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.
- 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.).
- History of cancer within 5 years prior to screening, except for cured cutaneous basal cell carcinoma or Stage I squamous cell carcinoma.
- 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.
- Presence of active autoimmune 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.).
- Use of topical anti-psoriatic drugs or physical therapy within 2 weeks prior to screening (see prohibited medications/therapies for details).
- Use of systemic anti-psoriatic drugs other than biologics within 4 weeks prior to screening (see prohibited medications for details).
- 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).
- Previous participation in and receipt of study drug in the LZM012 clinical trial.
- Participation in any clinical trial of an investigational drug (defined as having received study drug) within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
- Any of the following laboratory results at screening:
- (A)Hematology: hemoglobin (HGB) <90 g/L; platelet count (PLT) <100 × 10⁹/L; white blood cell count (WBC) <3 × 10⁹/L; absolute neutrophil count (NEUT) <1.5 × 10⁹/L;
- (B)Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN), or total bilirubin >1.5 times ULN;
- (C)Renal function: serum creatinine >1.5 times ULN.
- Receipt of a live vaccine (including attenuated live vaccine) within 3 months prior to screening, or planned receipt of a live vaccine (including attenuated live vaccine) during the trial.
- Meeting any of the following at screening:
- (A)Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with further testing showing HBV-DNA ≥500 IU/mL;
- (B)Positive hepatitis C 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.).
- Pregnant or breastfeeding women, or positive pregnancy test result at screening.
- Any other condition or situation that, in the investigator's opinion, makes the subject unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- LZM012
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LZM012Biological
Recombinant anti-human IL-17A/F humanized monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| LZM012 Monotherapy Group | Experimental | 320mg LZM012 subcutaneous injection every 4 weeks for 3 doses, no dose adjustment permitted. Receives: Biological: LZM012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI100 response rate
The ratio of patients reached PASI100 (PASI100 response rate)
Measured: At week 12
Secondary outcomes (26)
Time to first achievement of PASI50, PASI75, PASI90 and PASI100
Measured: Up to Week 12
PASI75/PASI90 response rate
Measured: At week 4、 At week 8、 At week 12
Absolute and relative percentage change from baseline in PASI score at each visit
Measured: at Week 4, Week 8, Week 12
sPGA 0/1 response rate
Measured: At week 4、 At week 8、 At week 12
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.
Measured: At week 4、 At week 8、 At week 12
treatment-emergent adverse events
Measured: up to week 16
Vital signs: systolic blood pressure
Measured: Up to Week 16
Vital signs: diastolic blood pressure
Measured: Up to Week 16
Vital signs: pulse rate
Measured: up to week 16
Vital signs: tympanic temperature
Measured: up to week 16
Electrocardiogram (ECG): PR interval, QT interval
Measured: Up to Week 16
Electrocardiogram (ECG): heart rate
Measured: up to week 16
physical examinatio: Proportion of subjects with abnormal skin findings on physical examination
Measured: Up to Week 16
physical examination:Proportion of subjects with abnormal head and neck findings on physical examination
Measured: up to week 16
physical examination:Proportion of subjects with abnormal chest findings on physical examination
Measured: up to week 16
physical examination:Proportion of subjects with abnormal abdomen findings on physical examination
Measured: up to week 16
physical examination:Proportion of subjects with abnormal extremities findings on physical examination
Measured: up to week 16
Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) positive
Measured: From baseline to Week 12
Laboratory tests: hematology：Platelet count, Neutrophil count, Lymphocyte count, White blood cell (WBC) count
Measured: up to week 16
Laboratory tests: hematology:Hemoglobin (Hb)
Measured: up to week 16
Laboratory tests: hematology:Hematocrit (Hct), Neutrophil percentage
Measured: up to week 16
Laboratory tests: serum biochemistry:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Creatine phosphokinase (CPK)
Measured: up to week 16
Laboratory tests: serum biochemistry:Total bilirubin (TBIL), Direct bilirubin (DBIL), Creatinine (Cr), Uric acid (UA);
Measured: up to week 16
Laboratory tests: serum biochemistry:Total cholesterol (TC), Triglycerides (TG), Low-density lipoprotein cholesterol (LDL-C), Glucose (GLU)
Measured: up to week 16
Laboratory tests: urinalysis:Urine protein, urine glucose, urine ketone bodies;
Measured: up to week 16
Laboratory tests: urinalysis:Urine leukocytes, urine erythrocytes
Measured: up to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start23 Jun 2025
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746479
- Sponsor's protocol ID
- LZM012-302
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07746479
- Acronym / sponsor ID
- LZM012-302
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LZM012 Monotherapy Group | Experimental | Biological: LZM012320mg LZM012 subcutaneous injection every 4 weeks for 3 doses, no dose adjustment permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (39 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LZM012Recombinant anti-human IL-17A/F humanized monoclonal antibody injection | Biological | LZM012 Monotherapy Group |
Primary outcome
PASI100 response rate
Time frame: At week 12
The ratio of patients reached PASI100 (PASI100 response rate)
26 secondary outcomes
Time to first achievement of PASI50, PASI75, PASI90 and PASI100
Time frame: Up to Week 12
PASI75/PASI90 response rate
Time frame: At week 4、 At week 8、 At week 12
Absolute and relative percentage change from baseline in PASI score at each visit
Time frame: at Week 4, Week 8, Week 12
sPGA 0/1 response rate
Time frame: At week 4、 At week 8、 At week 12
change in Dermatology Life Quality Index (DLQI) score
Time frame: At week 4、 At week 8、 At week 12
treatment-emergent adverse events
Time frame: up to week 16
Vital signs: systolic blood pressure
Time frame: Up to Week 16
Vital signs: diastolic blood pressure
Time frame: Up to Week 16
Vital signs: pulse rate
Time frame: up to week 16
Vital signs: tympanic temperature
Time frame: up to week 16
Electrocardiogram (ECG): PR interval, QT interval
Time frame: Up to Week 16
Electrocardiogram (ECG): heart rate
Time frame: up to week 16
physical examinatio: Proportion of subjects with abnormal skin findings on physical examination
Time frame: Up to Week 16
physical examination:Proportion of subjects with abnormal head and neck findings on physical examination
Time frame: up to week 16
physical examination:Proportion of subjects with abnormal chest findings on physical examination
Time frame: up to week 16
physical examination:Proportion of subjects with abnormal abdomen findings on physical examination
Time frame: up to week 16
physical examination:Proportion of subjects with abnormal extremities findings on physical examination
Time frame: up to week 16
Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) positive
Time frame: From baseline to Week 12
Laboratory tests: hematology：Platelet count, Neutrophil count, Lymphocyte count, White blood cell (WBC) count
Time frame: up to week 16
Laboratory tests: hematology:Hemoglobin (Hb)
Time frame: up to week 16
Laboratory tests: hematology:Hematocrit (Hct), Neutrophil percentage
Time frame: up to week 16
Laboratory tests: serum biochemistry:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Creatine phosphokinase (CPK)
Time frame: up to week 16
Laboratory tests: serum biochemistry:Total bilirubin (TBIL), Direct bilirubin (DBIL), Creatinine (Cr), Uric acid (UA);
Time frame: up to week 16
Laboratory tests: serum biochemistry:Total cholesterol (TC), Triglycerides (TG), Low-density lipoprotein cholesterol (LDL-C), Glucose (GLU)
Time frame: up to week 16
Laboratory tests: urinalysis:Urine protein, urine glucose, urine ketone bodies;
Time frame: up to week 16
Laboratory tests: urinalysis:Urine leukocytes, urine erythrocytes
Time frame: up to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LZM012 in people with Psoriasis, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI100 response rate (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.