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Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

2022年7月14日 更新者：UCB Biopharma S.P.R.L.

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

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

250

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Edmonton、加拿大
        • Ps0010 209
      • Quebec City、加拿大
        • Ps0010 214
    • British Columbia
      • Surrey、British Columbia、加拿大
        • Ps0010 203
    • Ontario
      • Hamilton、Ontario、加拿大
        • Ps0010 204
      • North Bay、Ontario、加拿大
        • Ps0010 201
      • Peterborough、Ontario、加拿大
        • Ps0010 206
      • Waterloo、Ontario、加拿大
        • Ps0010 205
    • Quebec
      • Quebec City、Quebec、加拿大
        • Ps0010 214
  • 匈牙利
      • Kecskemet、匈牙利
        • Ps0010 404
      • Oroshaza、匈牙利
        • Ps0010 400
      • Szekszard、匈牙利
        • Ps0010 405
  • 捷克语
      • Ostrava Poruba、捷克语
        • Ps0010 300
      • Pardubice、捷克语
        • Ps0010 303
      • Praha、捷克语
        • Ps0010 301
      • Praha、捷克语
        • Ps0010 304
  • 日本
      • Nagoya、日本
        • Ps0010 502
      • Shinaga Wa-ku、日本
        • Ps0010 501
      • Tokio、日本
        • Ps0010 503
      • Tokyo、日本
        • Ps0010 504
  • 波兰
      • Bialystok、波兰
        • Ps0010 600
      • Bialystok、波兰
        • Ps0010 611
      • Gdansk、波兰
        • Ps0010 605
      • Gdynia、波兰
        • Ps0010 610
      • Kielce、波兰
        • Ps0010 604
      • Krakow、波兰
        • Ps0010 608
      • Lublin、波兰
        • Ps0010 606
      • Podlaski、波兰
        • Ps0010 603
      • Warszawa、波兰
        • Ps0010 607
      • Wroclaw、波兰
        • Ps0010 601
      • Wroclaw、波兰
        • Ps0010 609
  • 美国
    • California
      • Fremont、California、美国
        • Ps0010 711
      • Los Angeles、California、美国
        • Ps0010 708
    • District of Columbia
      • Washington、District of Columbia、美国
        • Ps0010 706
    • Iowa
      • West Des Moines、Iowa、美国
        • Ps0010 704
    • New York
      • Rochester、New York、美国
        • Ps0010 718
    • North Carolina
      • Wilmington、North Carolina、美国
        • Ps0010 738
    • Ohio
      • Cleveland、Ohio、美国
        • Ps0010 736
    • Oregon
      • Portland、Oregon、美国
        • Ps0010 712
    • Texas
      • Dallas、Texas、美国
        • Ps0010 733
      • Houston、Texas、美国
        • Ps0010 702
      • Houston、Texas、美国
        • Ps0010 709

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
其他：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
实验性的：Bimekizumab dosing regimen 1
其他：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
药品：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
其他名称：
  • UCB4940
实验性的：Bimekizumab dosing regimen 2
其他：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
药品：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
其他名称：
  • UCB4940
实验性的：Bimekizumab dosing regimen 3
其他：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
药品：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
其他名称：
  • UCB4940
实验性的：Bimekizumab dosing regimen 4
其他：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
药品：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
其他名称：
  • UCB4940
实验性的：Bimekizumab dosing regimen 5
药品：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
其他名称：
  • UCB4940

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
大体时间：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.
Week 12

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：Week 12
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
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
大体时间：Week 8
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Week 8
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
大体时间：Week 8
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.
Week 8
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
大体时间：Week 12
The PASI75 response assessments are based on at least 75% 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.
Week 12
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
大体时间：Week 12
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. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Week 12
Plasma Concentrations of Bimekizumab During the Study
大体时间：Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL).

Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
大体时间：From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
大体时间：From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
大体时间：From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)

The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm.

It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
大体时间：Baseline (Week 0)
Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).
Baseline (Week 0)
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
大体时间：From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
Percentage of Participants With at Least One Adverse Event (AE) During the Study
大体时间：From Screening to End of Safety Follow-up (up to Week 32)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
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
大体时间：From Screening to End of Safety Follow-up (up to Week 32)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
From Screening to End of Safety Follow-up (up to Week 32)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
大体时间：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)
Platelets was measured in number of platelets per liter (10^9/L).
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) Concentration, Hemoglobin)
大体时间：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)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
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))
大体时间：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)
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
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 Volume)
大体时间：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)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
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)
大体时间：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)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
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)
大体时间：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)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
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)
大体时间：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)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
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)
大体时间：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)
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
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)
大体时间：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)
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
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)
大体时间：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)
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
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)
大体时间：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)
C Reactive Protein was measured in milligrams per liters (mg/L).
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)
大体时间：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)
Urine pH was measured on a pH scale.
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)
大体时间：From Baseline (Week 0) until Week 12
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
大体时间：From Baseline (Week 0) until Week 12
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
大体时间：From Baseline (Week 0) until Week 12
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
大体时间：From Baseline (Week 0) until Week 12
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
From Baseline (Week 0) until Week 12
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
大体时间：From Baseline (Week 0) until Week 12
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
From Baseline (Week 0) until Week 12
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
大体时间：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)
Blood pressure was measured in millimeters of mercury (mmHg).
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 (Pulse Rate)
大体时间：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)
Pulse rate was measured in beats per minute (beats/min).
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)
大体时间：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)
Temperature was measured in degrees Celsius (°C).
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
大体时间：At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)

The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status.

Any clinically significant abnormal findings during the study were captured as adverse events.
At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
大体时间：Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Biopharma S.P.R.L.

合作者

Parexel

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年8月1日

初级完成 (实际的)

2017年6月1日

研究完成 (实际的)

2017年7月1日

研究注册日期

首次提交

2016年9月14日

首先提交符合 QC 标准的

2016年9月16日

首次发布 (估计)

2016年9月19日

研究记录更新

最后更新发布 (实际的)

2022年7月21日

上次提交的符合 QC 标准的更新

2022年7月14日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PS0010
  • 2016-001891-31 (EudraCT编号)

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Placebo的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in India

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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