このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

250

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
他の：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
実験的：Bimekizumab dosing regimen 1
他の：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
薬：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
他の名前：
  • UCB4940
実験的：Bimekizumab dosing regimen 2
他の：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
薬：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
他の名前：
  • UCB4940
実験的：Bimekizumab dosing regimen 3
他の：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
薬：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
他の名前：
  • UCB4940
実験的：Bimekizumab dosing regimen 4
他の：Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
薬：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
他の名前：
  • UCB4940
実験的：Bimekizumab dosing regimen 5
薬：Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
他の名前：
  • UCB4940

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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))
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

UCB Biopharma S.P.R.L.

協力者

Parexel

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年8月1日

一次修了 (実際)

2017年6月1日

研究の完了 (実際)

2017年7月1日

試験登録日

最初に提出

2016年9月14日

QC基準を満たした最初の提出物

2016年9月16日

最初の投稿 (見積もり)

2016年9月19日

学習記録の更新

投稿された最後の更新 (実際)

2022年7月21日

QC基準を満たした最後の更新が送信されました

2022年7月14日

最終確認日

2022年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Placeboの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Lebanon

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する