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

14 июля 2022 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

250

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Плацебо
Другой: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Экспериментальный: Bimekizumab dosing regimen 1
Другой: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Лекарство: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Другие имена:
  • UCB4940
Экспериментальный: Bimekizumab dosing regimen 2
Другой: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Лекарство: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Другие имена:
  • UCB4940
Экспериментальный: Bimekizumab dosing regimen 3
Другой: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Лекарство: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Другие имена:
  • UCB4940
Экспериментальный: Bimekizumab dosing regimen 4
Другой: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Лекарство: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Другие имена:
  • UCB4940
Экспериментальный: Bimekizumab dosing regimen 5
Лекарство: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Другие имена:
  • UCB4940

Что измеряет исследование?

Первичные показатели результатов

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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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))
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

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Спонсор

UCB Biopharma S.P.R.L.

Соавторы

Parexel

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2016 г.

Первичное завершение (Действительный)

1 июня 2017 г.

Завершение исследования (Действительный)

1 июля 2017 г.

Даты регистрации исследования

Первый отправленный

14 сентября 2016 г.

Впервые представлено, что соответствует критериям контроля качества

16 сентября 2016 г.

Первый опубликованный (Оценивать)

19 сентября 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 июля 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 июля 2022 г.

Последняя проверка

1 июля 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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