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临床试验/NCT02905006
NCT02905006已完成2 期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

UCB Biopharma S.P.R.L.40 个研究点 分布在 6 个国家目标入组 250 人开始时间: 2016年8月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
250
试验地点
40
主要终点
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Subject has provided informed consent
  • •Chronic plaque psoriasis for at least 6 months prior to Screening
  • •PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
  • •Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
  • •Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
  • •Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication

排除标准

  • •Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
  • •Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
  • •Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
  • •Subject taking prohibited psoriatic medications
  • •Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
  • •Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
  • •Subject has any current sign or symptom that may indicate an active infection (except for common cold)

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Other)

Bimekizumab dosing regimen 1

Experimental

干预措施: Bimekizumab (Drug)

Bimekizumab dosing regimen 1

Experimental

干预措施: Placebo (Other)

Bimekizumab dosing regimen 2

Experimental

干预措施: Bimekizumab (Drug)

Bimekizumab dosing regimen 2

Experimental

干预措施: Placebo (Other)

Bimekizumab dosing regimen 3

Experimental

干预措施: Bimekizumab (Drug)

Bimekizumab dosing regimen 3

Experimental

干预措施: Placebo (Other)

Bimekizumab dosing regimen 4

Experimental

干预措施: Bimekizumab (Drug)

Bimekizumab dosing regimen 4

Experimental

干预措施: Placebo (Other)

Bimekizumab dosing regimen 5

Experimental

干预措施: Bimekizumab (Drug)

结局指标

主要结局

Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

时间窗: Week 12

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

次要结局

  • Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab(From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28))
  • Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment(From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28))
  • Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12(Week 12)
  • Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12(Week 12)
  • Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12(Week 12)
  • Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8(Week 8)
  • Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8(Week 8)
  • Plasma Concentrations of Bimekizumab During the Study(Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)(From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)(From Baseline (Week 0) until Week 12)
  • Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)(From Baseline (Week 0) until Week 12)
  • Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)(From Baseline (Week 0) until Week 12)
  • Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Percentage of Participants With Clinically Significant Physical Examination Abnormalities(At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings(Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab(From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment(Baseline (Week 0))
  • Percentage of Participants With at Least One Adverse Event (AE) During the Study(From Screening to End of Safety Follow-up (up to Week 32))
  • Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity(From Screening to End of Safety Follow-up (up to Week 32))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)(From Baseline (Week 0) until Week 12)
  • Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)(From Baseline (Week 0) until Week 12)
  • Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))
  • Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)(Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose))

研究者

发起方
UCB Biopharma S.P.R.L.
申办方类型
Industry
责任方
Sponsor

研究点 (40)

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