NCT02581345已完成3 期
A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira® in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 572
- 试验地点
- 90
- 主要终点
- Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
研究概览
简要总结
The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants 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
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Must be able to understand and communicate with the investigator and comply with the requirements of the study
- •Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
- •Stable plaque psoriasis
- •History of receipt of or candidate for therapy.
- •Moderate to severe psoriasis at screening and baseline
- •Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
- •Male participants of childbearing potential must employ a highly effective contraceptive measure
- •Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating. Female participants must also agree to employ a highly effective contraceptive measure.
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Drug-induced psoriasis.
- •Other skin conditions which would interfere with assessment of psoriasis
- •Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
- •Other inflammatory conditions other than psoriasis or psoriatic arthritis
- •Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
- •Ongoing use of prohibited psoriasis treatments
- •Ongoing use of other non-psoriasis prohibited treatments
- •All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
- •Laboratory abnormalities at screening deemed clinically significant by the investigator
- •Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
- •History of latex allergy
- •History of or current signs or symptoms or diagnosis of a demyelinating disorder
- •History of or current Class III or IV New York Heart Association congestive heart failure
- •Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- •Current malignancy or history of any malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted
- •Chronic infections, recurrent infections; recent infection to be evaluated
- •History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
- •History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
- •Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
- •Participant is a family member or employee of the investigator or site staff or study team
研究组 & 干预措施
M923 and Humira
Other
Participants assigned to receive M923 and Humira
干预措施: Humira (Biological)
M923 and Humira
Other
Participants assigned to receive M923 and Humira
干预措施: M923 (Biological)
Humira
Active Comparator
Participants assigned to receive Humira
干预措施: Humira (Biological)
M923
Experimental
Participants assigned to receive M923
干预措施: M923 (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16
时间窗: Baseline; Week 16
The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.
次要结局
- Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Clinically Meaningful Changes in Vital Signs(Up to Week 52)
- Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16(Week 16)
- Number of Participants Achieving PASI 50 Response at Week 16(Baseline; Week 16)
- Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Number of Participants Achieving PASI 90 Response at Week 16(Baseline; Week 16)
- Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Absolute PASI Score at Baseline(Baseline)
- Absolute PASI Score at Week 16(Week 16)
- Absolute PASI Score at Week 52 (Follow-Up Visit)(Week 52)
- Percent Change From Baseline in PASI Score at Week 16(Baseline; Week 16)
- Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)(Baseline; Week 52)
- Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline(Baseline)
- Health-Related Quality of Life During Treatment: DLQI Score at Week 16(Week 16)
- Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)(Week 48)
- Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline(Baseline)
- Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline(Baseline)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline(Baseline)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16(Week 16)
- Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)(Week 48)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Week 52)
- Pharmacokinetics: Serum Concentrations by Treatment(Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41)
- Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline(Baseline (Week 0))
- Immunogenicity: Number of Participants With ADA at Week 16(Week 16)
- Immunogenicity: Number of Participants With ADA at Week 25(Week 25)
- Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)(Week 52)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline(Baseline (Week 0))
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16(Week 16)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25(Week 25)
- Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)(Week 52)
- Median Time to Seroconversion(Up to Week 52)
研究者
研究点 (90)
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