A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 76
- 主要终点
- Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
研究概览
简要总结
The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants greater than or equal to (>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
- •Participants must not have received more than 1 biologic therapy
- •Other protocol-defined inclusion criteria could apply
排除标准
- •Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
- •Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
- •Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis [TB]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
MSB11022 (Core Treatment Period)
Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
干预措施: MSB11022 (Drug)
EU-Humira
Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.
干预措施: Humira® (Drug)
MSB11022 (Extended Treatment Period)
Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
干预措施: MSB11022 (Drug)
EU-Humira/EU-Humira
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.
干预措施: Humira® (Drug)
EU-Humira/MSB11022
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
干预措施: MSB11022 (Drug)
EU-Humira/MSB11022
Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
干预措施: Humira® (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
时间窗: Week 16
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.
次要结局
- Observed Serum Concentration at Week 24 and 52(Week 24 and 52)
- Percent Change From Baseline in PASI at Week 16(Baseline (Day 1 of Core Treatment Period), Week 16)
- Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16(Week 16)
- Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24(Week 24)
- Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52(Week 52)
- Percent Change From Baseline in PASI at Week 24 and 52(Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52)
- Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 16(Baseline (Day 1 of Core Treatment Period), Week 16)
- Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to "Clear" or "Almost Clear" at Week 24 and 52(Baseline (Day 1 of Extended Treatment Period), Week 24 and 52)
- Time to Achieve PASI 50(Baseline (Day 1 of Core Treatment Period) up to Month 4)
- Time to Achieve PASI 75(Baseline (Day 1 of Core Treatment Period) up to Month 4)
- Time to Achieve PASI 90(Baseline (Day 1 of Core Treatment Period) up to Month 4)
- Time to Achieve PASI 100(Baseline (Day 1 of Core Treatment Period) up to Month 13.5)
- Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16(Baseline (Day 1 of Core Treatment Period), Week 16)
- Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24(Baseline (Day 1 of Extended Treatment Period), Week 24)
- Number of Participants With Clinically Meaningful Differences in Vital Signs(Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54)
- European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52(Week 24 and 52)
- Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52(Baseline (Day 1 of Extended Treatment Period), Week 52)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16(Baseline (Day 1 of Core Treatment Period) up to Week 16)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54(Baseline (Day 1 of Extended Treatment Period) up to Week 54)
- Number of Participants With Clinically Meaningful Differences in Laboratory Values(Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54)
- Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16(Week 16)
- Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52(Week 24, 32, 40 and 52)
- Dermatology Life Quality Index (DLQI) at Week 24 and 52(Week 24 and 52)
- European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52(Week 24 and 52)
- European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16(Week 16)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16(Week 16)
- Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)(Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54)
- Dermatology Life Quality Index (DLQI) at Week 16(Weeks 16)
- European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16(Week 16)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52(Week 24 and 52)
- Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52(Week 24, 32, 40 and 52)
- Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16(Week 16)
- Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52(Week 24 and 52)
- Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16(Week 16)
- Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52(Week 24, 32, 40 and 52)
- Observed Serum Concentration at Week 16(Week 16)