Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)
14 de julho de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
250
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Edmonton, Canadá
- Ps0010 209
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Quebec City, Canadá
- Ps0010 214
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British Columbia
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Surrey, British Columbia, Canadá
- Ps0010 203
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Ontario
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Hamilton, Ontario, Canadá
- Ps0010 204
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North Bay, Ontario, Canadá
- Ps0010 201
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Peterborough, Ontario, Canadá
- Ps0010 206
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Waterloo, Ontario, Canadá
- Ps0010 205
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Quebec
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Quebec City, Quebec, Canadá
- Ps0010 214
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California
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Fremont, California, Estados Unidos
- Ps0010 711
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Los Angeles, California, Estados Unidos
- Ps0010 708
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District of Columbia
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Washington, District of Columbia, Estados Unidos
- Ps0010 706
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Iowa
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West Des Moines, Iowa, Estados Unidos
- Ps0010 704
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New York
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Rochester, New York, Estados Unidos
- Ps0010 718
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North Carolina
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Wilmington, North Carolina, Estados Unidos
- Ps0010 738
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Ohio
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Cleveland, Ohio, Estados Unidos
- Ps0010 736
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Oregon
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Portland, Oregon, Estados Unidos
- Ps0010 712
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Texas
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Dallas, Texas, Estados Unidos
- Ps0010 733
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Houston, Texas, Estados Unidos
- Ps0010 702
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Houston, Texas, Estados Unidos
- Ps0010 709
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Kecskemet, Hungria
- Ps0010 404
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Oroshaza, Hungria
- Ps0010 400
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Szekszard, Hungria
- Ps0010 405
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Nagoya, Japão
- Ps0010 502
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Shinaga Wa-ku, Japão
- Ps0010 501
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Tokio, Japão
- Ps0010 503
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Tokyo, Japão
- Ps0010 504
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Bialystok, Polônia
- Ps0010 600
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Bialystok, Polônia
- Ps0010 611
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Gdansk, Polônia
- Ps0010 605
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Gdynia, Polônia
- Ps0010 610
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Kielce, Polônia
- Ps0010 604
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Krakow, Polônia
- Ps0010 608
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Lublin, Polônia
- Ps0010 606
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Podlaski, Polônia
- Ps0010 603
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Warszawa, Polônia
- Ps0010 607
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Wroclaw, Polônia
- Ps0010 601
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Wroclaw, Polônia
- Ps0010 609
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Ostrava Poruba, Tcheca
- Ps0010 300
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Pardubice, Tcheca
- Ps0010 303
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Praha, Tcheca
- Ps0010 301
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Praha, Tcheca
- Ps0010 304
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo
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Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
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Experimental: Bimekizumab dosing regimen 1
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Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Outros nomes:
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Experimental: Bimekizumab dosing regimen 2
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Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Outros nomes:
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Experimental: Bimekizumab dosing regimen 3
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Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Outros nomes:
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Experimental: Bimekizumab dosing regimen 4
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Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Outros nomes:
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Experimental: Bimekizumab dosing regimen 5
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Subjects will be randomized to receive a combination of injections of Bimekizumab.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Prazo: Week 12
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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.
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Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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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
Prazo: Week 12
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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.
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Week 12
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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
Prazo: Week 8
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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.
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Week 8
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Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
Prazo: Week 8
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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.
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Week 8
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Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
Prazo: Week 12
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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.
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Week 12
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Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
Prazo: Week 12
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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.
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Week 12
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Plasma Concentrations of Bimekizumab During the Study
Prazo: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
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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)
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Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
Prazo: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
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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)
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Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
Prazo: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
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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)
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Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
Prazo: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
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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)
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Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Prazo: Baseline (Week 0)
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Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).
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Baseline (Week 0)
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Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Prazo: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
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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.
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From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
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Percentage of Participants With at Least One Adverse Event (AE) During the Study
Prazo: From Screening to End of Safety Follow-up (up to Week 32)
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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.
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From Screening to End of Safety Follow-up (up to Week 32)
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Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
Prazo: From Screening to End of Safety Follow-up (up to Week 32)
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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.
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From Screening to End of Safety Follow-up (up to Week 32)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Prazo: 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)
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Platelets was measured in number of platelets per liter (10^9/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Prazo: 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)
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Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Prazo: 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)
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Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Prazo: 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)
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Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Prazo: 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)
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Erythrocytes was measured in number of red blood cells per liter (10^12/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Prazo: 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)
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Hematocrit was measured in volume percentage (%) of red blood cells in blood.
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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)
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Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Prazo: 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)
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Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Prazo: 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)
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Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Prazo: 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)
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Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Prazo: 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)
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Creatinine and bilirubin were measured in micromols per liter (μmol/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
Prazo: 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)
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C Reactive Protein was measured in milligrams per liters (mg/L).
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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)
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Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Prazo: 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)
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Urine pH was measured on a pH scale.
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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)
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Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Prazo: From Baseline (Week 0) until Week 12
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Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
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From Baseline (Week 0) until Week 12
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Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
Prazo: From Baseline (Week 0) until Week 12
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Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
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From Baseline (Week 0) until Week 12
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Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
Prazo: From Baseline (Week 0) until Week 12
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Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
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From Baseline (Week 0) until Week 12
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Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
Prazo: From Baseline (Week 0) until Week 12
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Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
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From Baseline (Week 0) until Week 12
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Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
Prazo: From Baseline (Week 0) until Week 12
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Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
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From Baseline (Week 0) until Week 12
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Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Prazo: 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)
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Blood pressure was measured in millimeters of mercury (mmHg).
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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)
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Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Prazo: 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)
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Pulse rate was measured in beats per minute (beats/min).
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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)
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Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
Prazo: 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)
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Temperature was measured in degrees Celsius (°C).
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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)
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Percentage of Participants With Clinically Significant Physical Examination Abnormalities
Prazo: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
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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)
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Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Prazo: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
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Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
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Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2016
Conclusão Primária (Real)
1 de junho de 2017
Conclusão do estudo (Real)
1 de julho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
14 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de setembro de 2016
Primeira postagem (Estimativa)
19 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PS0010
- 2016-001891-31 (Número EudraCT)
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