NCT05335356已完成3 期
A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
Biocon Biologics UK Ltd1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2022年6月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
详细描述
Approximately 384 patients with moderate to severe plaque psoriasis will be enrolled and randomly assigned to one of the 2 treatment groups in a 1:1 ratio (192 patients in the Bmab 1200 group and 192 patients in the Stelara group). Patients who are diagnosed as moderate to severe chronic plaque psoriasis for at least 6 months and are candidate for systemic therapy or phototherapy at the time of the screening visit will be enrolled. The study is planned to be conducted in Europe and North America across approximately 48 sites in 5 countries. The study will be conducted in an outpatient setting, and the participation for each patient will consist of a screening period (up to 4 weeks/28 days) and a double-blind, active-controlled treatment period (52 weeks) with a rerandomization step for switching therapy (Bmab 1200 with Stelara ) before Week 16 dosing. The treatment period before the switch is TP1(Treatment Period1) and post switch is TP2(Treatment Period 2) (from Week 16 dosing to prior to Week 28 dosing) and TP3 (Treatment Period3)(from Week 28 dosing to Week 52). The total duration of the study (excluding the screening period) will be 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blinded (Patient, Investigator),
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion.
- •Patient is aged 18 to 80 years, both inclusive, and weighing <130 kg at the time of the screening visit.
- •Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate for systemic therapy or phototherapy at the time of the screening visit.
- •Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement
- •10%, PASI score ≥12, and sPGA ≥3 at the screening and baseline visits.
- •Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
- •Patient has adequate renal and hepatic function at the screening
- •Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. A female patient is considered not of childbearing potential when postmenopausal or surgically sterilized
- •Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.
排除标准
- •Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment on psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate.
- •Patient who has a current or past history of any of the following infections:
- •Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening.
- •Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening.
- •For HBV, patients who test positive to hepatitis B surface antigen (HBsAg) will be excluded. Patients who test positive to hepatitis B core antibody (HBcAb) only (HBsAg negative), may be enrolled if they also test positive to hepatitis B surface antibody (HBsAb).
- •For HCV, patient who test positive to HCV antibody will be excluded unless they test negative for HCV RNA.
- •Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization ≤8 weeks before baseline visit, or oral/intramuscular antibiotics ≤4 weeks before baseline visit, or topical antibiotics ≤2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed.
- •Any recurrent bacterial, fungal, opportunistic or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study.
- •History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.
- •Patient meeting any of the following tuberculosis (TB)-related conditions:
- •Patient who has current or history of active TB.
- •Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening. If a chest radiography performed within the past 3 months before screening is available, it does not need to be repeated at screening.
- •Patients with current latent TB (defined as a positive result of interferon-γ release assay [IGRA] with a negative examination of chest radiography [posterior-anterior and lateral views, or per country regulations where applicable] and absence of symptoms). Patients with positive IGRA (Interferon Gamma Release Assay) may be enrolled if they have documentation of completed appropriate country-specific TB prophylaxis within the past 5 years or have received at least 1 month of country-specific TB prophylaxis before the baseline visit and are willing to complete its entire course, and do not have other risk factors, radiologic findings, or physical evidence supporting latent or active TB. If a patient's initial IGRA test result is indeterminate, the test can be repeated once. If the test result is again indeterminate, the patient will be excluded from the study.
- •Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit.
- •Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
- •Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
- •Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.
- •Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis:
- •Patient has received a live or live-attenuated vaccine within 4 weeks before the baseline visit. Patient must agree not to receive a live or live-attenuated vaccine during the study and up to 15 weeks after the last dose of the study treatment.
- •Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year before the baseline visit. Patients must agree not to receive a BCG vaccination during the study and at least 1 year after the last dose of the study treatment.
- •Have a transplanted organ/tissue or stem cell transplantation.
- •TP3 specific criteria:
- •Patient is willing and able to provide revised informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion
- •Patient has not developed any condition/ or met study discontinuation or treatment
研究组 & 干预措施
Bmab1200
Experimental
Bmab 1200 45 mg Bmab 1200 90 mg
干预措施: Bmab1200 (Biological)
Stelara
Active Comparator
Stelara 45 mg Stelara 90 mg
干预措施: Stelara (Biological)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI)
时间窗: Baseline to Week 12
Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12
次要结局
- PASI Score(Baseline through Week 52)
- PASI Improvement(Baseline through week 52)
- Static Physician's Global Assessment (sPGA)(Baseline through Week 52)
- Affected Body Surface Area(Baseline through Week 52)
- Dermatology Life Quality Index Scores(Baseline through Week 52)
研究者
研究点 (1)
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