PsoriasisPhase 3PsoriasisNCT06110676
A Study to Evaluate the Efficacy and Safety of LZM012
A Phase 3 study testing LZM012 and Secukinumab in people with Psoriasis, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial 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 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 and Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 918 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to Jun 2025
- 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
- Male or female age ≥ 18 years at screening;
- 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%
- Moderate to severe plaque psoriasis patients who are eligible for systemic therapy or phototherapy, defined as one of the following:
Show all 16Show fewer
- 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;
- 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 contraindications as described in the secukinumab insert according to investigator's assessment;
- Female patients must meet one of the following criteria:
- Postmenopausal 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 childbearing potential 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 contraception (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;
- Voluntarily participate in the study and sign an informed consent form (ICF) in writing, willing and able to comply with the study visit schedule and other requirements of the study protocol.
Who cannot join
- 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;
- Patients with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or drug-induced psoriasis at the time of screening;
- 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;
- 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;
- 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.);
- 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;
Show all 39Show fewer
- Patients with any history of active malignancy 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.);
- Patients with a history of lymphoproliferative disorders, including signs and symptoms of lymphoma or underlying lymphoproliferative disorders;
- 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;
- Patients with inflammatory or autoimmune 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.);
- 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;
- 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 glucocorticoids, 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;
- Patients received intra-articular corticosteroids 4 weeks or 5 half-lives (whichever is longer) before baseline;
- Patients received physiotherapy (including psoralen and phototherapy/ photochemistry, tanning bed self-treatment, etc.) within 4 weeks before baseline;
- 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
- 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;
- 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;
- Patients participated in clinical trials of any topical therapeutic agent (defined as have been administered) within 1 month before baseline;
- 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;
- Patients received a live vaccine (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;
- Lab test results meet any of the following conditions during screening period:
- Blood routine: hemoglobin (HGB) <90g/L; Platelet count (PLT) < 100*109/L; Blood leukocytes (WBC) < 3*109/L; Absolute value (NEUT) of blood neutrophils< 1.5*109/L;
- Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the upper limit of normal value (ULN) by 3 times or total bilirubin 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;
- Patients showed positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (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 hepatitis B 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;
- Female subjects of childbearing potential tested positive for pregnancy during screening/baseline;
- Lactating women;
- Those considered by the investigator as inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200000
Zhang Jing, Dr., +86-13816357089
About this study
Official title: 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
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
- Conditions
- Psoriasis
- Being tested
- LZM012, Secukinumab
- 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
SecukinumabBiological
Cosentyx
| Study group | Role | What they receive |
|---|---|---|
| LZM012 Q4W | Experimental | Patients receive 320mg of LZM012 treatment once every 4 weeks Receives: Biological: LZM012 |
| LZM012 Q4W-Q8W | Experimental | Patients receive 320mg of LZM012 treatment once every 4 weeks till 12th week, then once evey 8 weeks Receives: Biological: LZM012 |
| Active control | Active comparator | Patients receive 300mg of secukinumab treatment once every 4 weeks Receives: Biological: Secukinumab |
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 (4)
PASI100 response rate
Compare the efficacy of LZM012 and Secukinumab
Measured: At week 52
PASI 75 response rate
Compare the efficacy of LZM012 and Secukinumab
Measured: At week 4
PASI 90 response rate
Compare the efficacy of LZM012 and Secukinumab
Measured: At week 12
sPGA0/1 response rate
Compare the efficacy of LZM012 and Secukinumab
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start21 Aug 2023
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 918 participants (estimated)
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
- NCT06110676
- Sponsor's protocol ID
- LZM012-III
- Acronym
- Psoriasis
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06110676
- Acronym / sponsor ID
- Psoriasis / LZM012-III
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 918 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Nov 2023 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LZM012 Q4W | Experimental | Biological: LZM012Patients receive 320mg of LZM012 treatment once every 4 weeks |
| LZM012 Q4W-Q8W | Experimental | Biological: LZM012Patients receive 320mg of LZM012 treatment once every 4 weeks till 12th week, then once evey 8 weeks |
| Active control | Active comparator | Biological: SecukinumabPatients receive 300mg of secukinumab treatment once every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female age ≥ 18 years at screening;
- 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:
- Moderate to severe plaque psoriasis patients who are eligible for systemic therapy or phototherapy, defined as one of the following:
- 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 contraindications as described in the secukinumab insert according to investigator's assessment;
- Female patients must meet one of the following criteria:
Key exclusion criteria (39 listed)
- 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;
- Patients with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or drug-induced psoriasis at the time of screening;
- 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;
- 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;
- 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.);
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 Q4W, LZM012 Q4W-Q8W |
| SecukinumabCosentyx | Biological | Active control |
Primary outcome
PASI100 response rate
Time frame: At week 12
The ratio of patients reached PASI100 (PASI100 response rate)
4 secondary outcomes
PASI100 response rate
Time frame: At week 52
PASI 75 response rate
Time frame: At week 4
PASI 90 response rate
Time frame: At week 12
sPGA0/1 response rate
Time frame: At week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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.
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 and Secukinumab 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 16 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Jinhua, Dr. (+86-13818978539, xjhhsyy@163.com), or a site near the patient. 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 1 Nov 2023.