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RecruitingNCT06110676PsoriasisUpdated Nov 1, 2023

A Study to Evaluate the Efficacy and Safety of LZM012

A Phase 3 interventional study of LZM012 and Secukinumab in Psoriasis, sponsored by Livzon Pharmaceutical Group Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.

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

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
918
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a muti-center, randomized, double blind, positive control phase III clinical study to evaluate the efficacy and safety of LZM012 in moderate to severe chronic plaque psoriasis patients

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 planned enrollment of 918 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. Male or female age ≥ 18 years at screening;
  2. Patients with moderate to severe plaque psoriasis history with or without psoriatic arthritis for at least ≥6 months prior to baseline, and meet the following 3 criteria at screening and baseline:

    • PASI score ≥12
    • sPGA score ≥3
    • BSA ≥10%
  3. Moderate to severe plaque psoriasis patients who are eligible for systemic therapy or phototherapy, defined as one of the following:

    • Insufficient efficacy after topical and/or phototherapy, photochemotherapy, and/or previous systemic therapy;
    • Intolerance to conventional therapy;
    • High SAE risk after conventional therapy;
    • Not suitable for conventional treatment due to comorbidities;
  4. Patients meet the indications specified in the secukinumab label (i.e., adult patients with moderate to severe plaque psoriasis who meet the indications for systemic therapy or phototherapy) and had no as described in the secukinumab insert according to investigator's assessment;
  5. Female patients must meet one of the following criteria:

    • period. Menopause is defined as: 12 consecutive months of menopause in a woman over 40 years of age, excluding pregnancy and other conditions that may cause amenorrhea;
    • Permanent sterilization (e.g., tubal obstruction, hysterectomy, bilateral salpingectomy, etc.);
    • Women of who have no fertility or egg donation plans during treatment and for at least 6 months after the last trial drug treatment, and voluntarily use highly effective (negative pregnancy test at screening and baseline); Male patients had no fertility or sperm donation plans during treatment and at least 6 months after the last trial drug treatment, and voluntarily took highly effective contraceptive measures;
  6. Voluntarily participate in the study and sign an form (ICF) in writing, willing and able to comply with the study visit schedule and other requirements of the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are allergic to any component of the test drug, or who have had a severe allergic reaction to monoclonal antibodies, or who are judged by the investigator to be at risk of severe allergy to enter the study;
  2. Patients with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or drug-induced psoriasis at the time of screening;
  3. Patients with progressive or uncontrolled systemic diseases such as kidney, liver, blood, gastrointestinal, endocrine, pulmonary, heart, neurological, psychiatric diseases, etc., who are not suitable to participate in this clinical trial according to the assessment of investigators due to the instability or possibility of development of the above diseases during the trial;
  4. Patients with medical history, symptoms, signs or examination results suggested active tuberculosis, latent tuberculosis and inactive tuberculosis will be assessed by the investigators to participate in the trial or not;
  5. Infectious diseases: a. patients with any serious infection within 1 month prior to baseline, defined as hospitalization due to infection or requiring intravenous anti-infective treatment; b. history of opportunistic infection or recurrent, chronic infection, which the investigator believes may lead participants to terminate the study; Opportunistic infections include infections caused by uncommon pathogens (e.g., Pneumocystis jirovecii, Cryptococcus, etc.) or unusually severe infections caused by common pathogens (e.g., cytomegalovirus, herpesvirus, etc.);
  6. Patients with unstable cardiovascular and cerebrovascular diseases, defined as clinical deterioration phenomena (such as unstable angina, rapid atrial fibrillation, cerebral hemorrhage, acute cerebral infarction, etc.) within 3 months before screening, or hospitalization for cardiovascular and cerebrovascular diseases within 3 months before screening;
  7. Patients with any history of active or malignancy in the 5 years prior to screening; except cured cancers (e.g. basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, localized low-risk prostate cancer, papillary thyroid cancer, etc.) and carcinoma in situ that has been radically resected (e.g. intraductal carcinoma in situ, carcinoma in situ of the cervix, etc.);
  8. Patients with a history of lymphoproliferative disorders, including signs and symptoms of lymphoma or underlying lymphoproliferative disorders;
  9. Patients with a history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or history of illicit drug abuse in a year prior to screening;
  10. Patients with inflammatory or diseases other than psoriasis or psoriatic arthritis (e.g. inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.);
  11. Patients with a history of depression within one year prior to screening, or suicidal thoughts or any suicidal behavior assessed according to the Colombia-Suicide Severity Scale (C-SSRS) during the screening period or at baseline, patients who answered "yes" to any question on the C-SSRS questionnaire (questions 1\~5), or patients who were clinically judged by the investigator to be at risk of suicide, will be excluded;
  12. Patients who received topical anti-psoriasis therapy within 2 weeks prior to baseline, including:

    • topical therapeutic drugs/moisturizers/emollients/shampoos/shower gels containing moderate/potent/ultra-potent , tretinoins, vitamin D3 derivatives, calcineurin inhibitors, α or β hydroxy acids, phosphodiesterase inhibitors, etc.;
    • Topical Chinese medicine/proprietary Chinese medicine with psoriasis therapeutic effect;
    • Drugs / moisturizer / emollient / shampoo / shower gel and other products containing urea, >3% salicylic acid, coal tar;
  13. Patients received intra-articular corticosteroids 4 weeks or 5 half-lives (whichever is longer) before baseline;
  14. Patients received physiotherapy (including psoralen and phototherapy/ photochemistry, tanning bed self-treatment, etc.) within 4 weeks before baseline;
  15. Patients received non-biological systemic treatment of anti-psoriasis (including glucocorticoids, retinoids, cyclosporine, methotrexate, azathioprine, leflunomide, mycophenolate mofetil, tofacitinib, apremilast, traditional Chinese medicine/proprietary Chinese medicine, etc.) within 4 weeks before baseline
  16. Patients received the following biologics or biosimilars prior to baseline:

    • Anti-tumor necrosis factor-α (TNF-α): etanercept \< 28 days before baseline; Infliximab, golimumab, adalimumab, and Certolizumab Pegol \< 90 days before baseline;
    • Anti-IL-12/IL-23 antibodies: ustekinumab \< 6 months before baseline;
    • Anti-IL-23p19 antibodies: guselkumab \< 90 days before baseline;
    • Rituximab or abatacept \< 12 months before baseline;
  17. Patients received anti-IL-17 antibody or anti-IL-17 receptor antibody therapy (including LZM012): e.g., secukinumab, ixekizumab, brodalumab, bimekizumab, or other test drugs against IL-17 antibodies or anti-IL-17 receptor antibodies;
  18. Patients participated in clinical trials of any topical therapeutic agent (defined as have been administered) within 1 month before baseline;
  19. Patients participated in a clinical trial (defined as have been administered) of any systemic therapeutic within 3 months before baseline or within 5 half-lives of the trial drug, whichever is longer;
  20. Patients received a (including live attenuated vaccine) within 3 months prior to baseline or plan to receive a live vaccine (including live attenuated vaccine) during the trial or within 6 months of the last trial drug administration; or plan to receive live shingles vaccine within 12 months of the last trial drug administration;
  21. Lab test results meet any of the following conditions during screening period:

    • Blood routine: (HGB) \<90g/L; count (PLT) \< 100*109/L; Blood leukocytes (WBC) \< 3*109/L; Absolute value (NEUT) of blood neutrophils\< 1.5*109/L;
    • Liver function: (ALT) or aspartate aminotransferase (AST) exceeds the value (ULN) by 3 times or total exceeds 1.5 times the ULN;
    • Renal function: serum creatinine is greater than 1.5 times that of ULN;
    • Other abnormal laboratory test results, which may affect the subject's completion of the test or interfere with the test results as assessed by the investigator; Test could be repeated during the screening period for the false individual test results, or value near the limit, or inconclusive results, or according to the investigator's judgement. After re-test, subjects should not be randomized if the results still meet the above conditions;
  22. Patients showed positive for virus (HCV) antibodies, or (HIV), or anti-syphilis spiral antibody (TP-Ab) [rapid plasma reagin ring card test (RPR) or toluidine red unheated serum test (TRUST) negative can be enrolled], or virus surface antigen (HBsAg);

    Under the condition of HBsAg negative, if:

    • Patients showed negative for all antigen antibodies of Hepatitis B, or positive for hepatitis B virus surface antibody (HBsAb)[with or without hepatitis B virus core antibody (HBcAb) positive], can be enrolled without hepatitis B virus DNA testing;
    • Patients showed HBsAb negative and HBcAb positive, HBV-DNA test is required. If HBV-DNA result showed negative or below the upper limit of normal, the patient can be enrolled;
  23. Female subjects of tested positive for pregnancy during screening/baseline;
  24. Lactating women;
  25. Those considered by the investigator as inappropriate to participate in the study.
Terms in these criteria, in plain language(17)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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).

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.

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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
918 participants (estimated)

Study arms

  • Experimental
    LZM012 Q4W

    Patients receive 320mg of LZM012 treatment once every 4 weeks

    Biological: LZM012

  • Experimental
    LZM012 Q4W-Q8W

    Patients receive 320mg of LZM012 treatment once every 4 weeks till 12th week, then once evey 8 weeks

    Biological: LZM012

  • Active comparator
    Active control

    Patients receive 300mg of secukinumab treatment once every 4 weeks

    Biological: Secukinumab

Interventions

  • BiologicalLZM012

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

  • BiologicalSecukinumab

    Cosentyx

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. PASI100 response rate

    Compare the efficacy of LZM012 and Secukinumab

    Time frame: At week 52

  2. PASI 75 response rate

    Compare the efficacy of LZM012 and Secukinumab

    Time frame: At week 4

  3. PASI 90 response rate

    Compare the efficacy of LZM012 and Secukinumab

    Time frame: At week 12

  4. sPGA0/1 response rate

    Compare the efficacy of LZM012 and Secukinumab

    Time frame: At week 12

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06110676
Responsible party
Sponsor
First posted
Nov 1, 2023
Start date
Aug 21, 2023
Primary completion
Apr 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Nov 1, 2023

Study contacts

Xu Jinhua, Dr.
Contact
xjhhsyy@163.com
+86-13818978539

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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