A Study to Evaluate the Efficacy and Safety of LZM012

NCT06110676 | Unknown Phase 3 DMC

• 1 other identifier: LZM012-III
• Study Type: interventional
• Target: 918
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI100 response rate

  The ratio of patients reached PASI100 (PASI100 response rate)

  At week 12

Secondary Outcomes (4)

• PASI100 response rate

  At week 52

• PASI 75 response rate

  At week 4

• PASI 90 response rate

  At week 12

• sPGA0/1 response rate

  At week 12

Study Arms (3)

LZM012 Q4W

EXPERIMENTAL

Patients receive 320mg of LZM012 treatment once every 4 weeks

Biological: LZM012

LZM012 Q4W-Q8W

EXPERIMENTAL

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

Biological: LZM012

Active control

ACTIVE COMPARATOR

Patients receive 300mg of secukinumab treatment once every 4 weeks

Biological: Secukinumab

Interventions

LZM012 BIOLOGICAL

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

LZM012 Q4W; LZM012 Q4W-Q8W

Secukinumab BIOLOGICAL

Cosentyx

Active control

Eligibility Criteria

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

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xu Jinhua, Dr.

CONTACT

+86-13818978539; xjhhsyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: August 21, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CN (1)