Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Исследование по оценке эффективности и безопасности ABC008 при миозите с тельцами-включениями

8 сентября 2026 г. обновлено: Abcuro, Inc.

Рандомизированное двойное слепое плацебо-контролируемое многоцентровое исследование фазы II/III для оценки эффективности и безопасности ABC008 при лечении субъектов с миозитом с тельцами-включениями

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis Detailed Description: A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis Detailed Description: This is a Phase II/III randomized, double-blind, placebo-controlled, parallel multicenter study with 3 parts.

The study will include a sentinel cohort (Part A) of 30 subjects who will receive first three doses of the study drug. Safety data from subjects in the sentinel cohorts will be evaluated by a Data and Safety Monitoring Board (DSMB) before further dosing of the sentinel cohort, as well as initiation of enrollment in the double-blind safety and efficacy cohort (Part B). After completion of Part A or Part B, subjects have the option of enrolling in an open-label long-term extension study or progressing to the pharmacodynamics (PD) recovery cohort (Part C), to evaluate the recovery of the depletion of killer cell lectin-like receptor G1 (KLRG1)+ cells after the end of treatment with ABC008.

Efficacy, safety, HRQoL, and HRU assessments will be conducted. Blood samples will be obtained to evaluate the serum PK, PD, and immunogenicity of ABC008 throughout the study.

Тип исследования

Интервенционный

Регистрация (Действительный)

272

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

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

Места учебы

  • Австралия
    • New South Wales
      • Saint Leonards, New South Wales, Австралия, 2065
        • Royal North Shore Hospital
    • Queensland
      • Herston, Queensland, Австралия, 4006
        • Royal Brisbane and Women's Hospital
    • Western Australia
      • Nedlands, Western Australia, Австралия, 6009
        • Perron Institute for Neurological and Translational Science
  • Бельгия
      • Ghent, Бельгия, 9000
        • AZ Sint-Lucas & Volkskliniek
  • Германия
      • Berlin, Германия, 15562
        • Krankenhaus und Poliklinik Rüdersdorf GmbH
      • Düsseldorf, Германия, 40225
        • University Hosptial Duesseldorf
  • Канада
    • Alberta
      • Calgary, Alberta, Канада, 3M 1M4
        • Heritage Medical Research Clinic - University of Calgary
    • Quebec
      • Montreal, Quebec, Канада, H4A 3T2
        • Genge Partners Inc.
  • Соединенное Королевство
      • London, Соединенное Королевство, WC1N 3BG
        • University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)
      • Salford, Соединенное Королевство, M6 8HD
        • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
  • Соединенные Штаты
    • Arizona
      • Phoenix, Arizona, Соединенные Штаты, 85028
        • Neuromuscular Research Center
    • California
      • Irvine, California, Соединенные Штаты, 92868
        • University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
      • Los Angeles, California, Соединенные Штаты, 90095
        • UCLA Medical Center
      • Los Angeles, California, Соединенные Штаты, 90033
        • Keck Hosptial of USC
      • Palo Alto, California, Соединенные Штаты, 94304
        • Stanford Neuroscience Medical Center
      • San Francisco, California, Соединенные Штаты, 94143
        • University of California, San Francisco
    • Colorado
      • Aurora, Colorado, Соединенные Штаты, 80045
        • University of Colorado Hospital Anschutz Outpatient Pavillion
    • Connecticut
      • New Haven, Connecticut, Соединенные Штаты, 06519
        • Yale School of Medicine
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32224
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60611
        • Northwestern Memorial Hospital, Department of Neurology (Clinic)
    • Kansas
      • Kansas City, Kansas, Соединенные Штаты, 66160
        • University of Kansas Medical
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21224
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, Соединенные Штаты, 21287
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02114
        • Neuromuscular Diagnostic Center - Massachusetts General Hospital
      • Boston, Massachusetts, Соединенные Штаты, 021158
        • Brigham and Womens Hospital
    • Minnesota
      • Rochester, Minnesota, Соединенные Штаты, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Соединенные Штаты, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Соединенные Штаты, 98198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, Соединенные Штаты, 10021
        • Hospital for Special Surgery
      • New York, New York, Соединенные Штаты, 10032
        • Columbia University Medical Center / The Neurological Institute of New York
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты, 27710
        • Duke Neurological Disorders Clinic -1L
      • Winston-Salem, North Carolina, Соединенные Штаты, 27157
        • Wake Forrest School of Medicine
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, Соединенные Штаты, 43210
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Hershey, Pennsylvania, Соединенные Штаты, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
        • UPMC Arthritis and Autoimmunity Center, Falk Clinic
    • Texas
      • Austin, Texas, Соединенные Штаты, 78759
        • Austin Neuromuscular Center
      • Dallas, Texas, Соединенные Штаты, 75206
        • Texas Neurology
      • Houston, Texas, Соединенные Штаты, 77030
        • Nerve and Muscle Center of Texas
    • Virginia
      • Henrico, Virginia, Соединенные Штаты, 23233
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98195
        • University of Washington Medical Center - Montlake
    • Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Medical College of Wisconsin
  • Франция
      • Paris, Франция, 75013
        • Hospital Pitie-Salpetriere - AP-HP

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

40 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Adult males and females age >40 years at the time of the first dose of study medication;
  • Weight >40 and <150 kg;
  • Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 research diagnostic criteria (Rose et al., 2013). Documented histopathology results must be available prior to Baseline (Day 1) to confirm eligibility;
  • Able to arise from a chair (with armrests), with use of their arms but without support from another person or device (e.g., cane, walking stick), at Screening and Baseline (Day 1);
  • Able to walk 3 meters, turn around, walk back to the chair, and sit down, with or without assistive device. Once arisen from the chair, subject may use any walking device but cannot be supported by another person, furniture, or a wall;

Exclusion Criteria:

  • Any other form of myositis or myopathy other than IBM, e.g., metabolic or drug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositis or dermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years, either before or after), myositis in overlap with another autoimmune disease (e.g., systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy;
  • Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG), in the Investigator's opinion;.
  • Presence of another autoimmune or autoinflammatory disease other than indication under study, e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus. Subjects with Sjogren's syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted;

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
Активный компаратор: 0.5 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Лекарство: ABC008

Given by subcutaneous injection
Активный компаратор: 2.0 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Лекарство: ABC008

Given by subcutaneous injection
Плацебо Компаратор: Placebo

Part A - Placebo N= 6

Part B - Placebo N= 67
Лекарство: ABC008

Given by subcutaneous injection

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Временное ограничение: Up to Week 80

An adverse event (AE) was defined as any untoward medical occurrence in any participant participating in a clinical investigation, regardless of the suspected cause. An AE was therefore any unfavorable and unintended sign, symptom, disease, concurrent illness, or clinically significant abnormal laboratory finding that emerged or worsened during the study. A TEAE was defined as an AE that first occurred or worsened after initiation of study drug.
Up to Week 80
Part A: Number of Participants With TEAEs by Severity
Временное ограничение: Up to Week 80

A TEAE was defined as an AE that first occurred or worsened after initiation of study drug and was graded by severity per protocol-specified Common Terminology Criteria for Adverse Events (CTCAE) criteria: Grade 1, Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2, Moderate (minimal, local, or noninvasive intervention indicated; limited age-appropriate instrumental activities of daily living (ADL)); Grade 3, Severe or medically significant (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care ADL); Grade 4, Life-threatening (threatening consequences; urgent intervention indicated); and Grade 5, Death (death related to an AE).
Up to Week 80
Part A: Number of Participants With TEAEs Related to Study Drug
Временное ограничение: Up to Week 80

An AE was defined as any untoward medical occurrence in any participant participating in a clinical investigation, regardless of the suspected cause. An AE was therefore can be any unfavorable and unintended sign, symptom, disease, concurrent illness, or clinically significant abnormal laboratory finding that emerged or worsened during the study. A TEAE was defined as an AE that first occurred or worsened after initiation of study drug. An AE with missing relationship to study drug was considered as related to study drug.
Up to Week 80
Part A: Mean Change From Baseline in the Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score at Week 76
Временное ограничение: Baseline (Day 1) and at Week 76

The IBMFRS was used as an ordinal rating scale to determine participant's assessments of their capabilities. It included 10 measures (swallowing, handwriting, cutting food and handling utensils, fine motor tasks, dressing, hygiene, turning in bed and adjusting covers, changing position from sitting to standing, walking, and climbing stairs) graded on a Likert scale (a psychometric tool) from 0 (being unable to perform) to 4 (normal). The sum of the 10 items provided a value between 0 and 40, with a higher score representing less functional limitation or better functional status. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and at Week 76
Part B: Number of Participants With TEAEs
Временное ограничение: Day 1 to Week 80

An AE was defined as any untoward medical occurrence in any participant participating in a clinical investigation, regardless of the suspected cause. An AE was therefore can be any unfavorable and unintended sign, symptom, disease, concurrent illness, or clinically significant abnormal laboratory finding that emerged or worsened during the study. A TEAE was defined as an AE that first occurred or worsened after initiation of study drug.
Day 1 to Week 80
Part B: Number of Participants With TEAEs by Severity
Временное ограничение: Day 1 to Week 80

A TEAE was defined as an AE that first occurred or worsened after initiation of study drug and was graded by severity per protocol-specified CTCAE criteria: Grade 1, Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2, Moderate (minimal, local, or noninvasive intervention indicated; limited age-appropriate instrumental ADL); Grade 3, Severe or medically significant (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care ADL); Grade 4, Life-threatening (threatening consequences; urgent intervention indicated); and Grade 5, Death (death related to an AE).
Day 1 to Week 80
Part B: Number of Participants With TEAEs Related to Study Drug
Временное ограничение: Day 1 to Week 80

An AE was defined as any untoward medical occurrence in any participant participating in a clinical investigation, regardless of the suspected cause. An AE was therefore can be any unfavorable and unintended sign, symptom, disease, concurrent illness, or clinically significant abnormal laboratory finding that emerged or worsened during the study. A TEAE was defined as an AE that first occurred or worsened after initiation of study drug. An AE with missing relationship to study drug was considered as related to study drug.
Day 1 to Week 80
Part B: Mean Change From Baseline in the IBMFRS Total Score at Week 76
Временное ограничение: Baseline (Day 1) and Up to Week 76

The IBMFRS was used as an ordinal rating scale to determine participant's assessments of their capabilities. It included 10 measures (swallowing, handwriting, cutting food and handling utensils, fine motor tasks, dressing, hygiene, turning in bed and adjusting covers, changing position from sitting to standing, walking, and climbing stairs) graded on a Likert scale (a psychometric tool) from 0 (being unable to perform) to 4 (normal). The sum of the 10 items provided a value between 0 and 40, with a higher score representing less functional limitation or better functional status. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and Up to Week 76
Part C: Time to PD Recovery
Временное ограничение: Up to Week 24

Recovery was defined as the return of KLRG1+ cell counts toward baseline levels during the PD follow-up period.
Up to Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part A and B: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: Up to Week 80

A TESAE was defined as a serious AE that first occurred or worsened after initiation of study drug and met seriousness criteria per protocol (including death, life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, congenital anomaly, or other medically important event).
Up to Week 80
Part A and B: Number of Participants With TEAEs With Onset Within 24 Hours From the Start of Any Study Medication Administration
Временное ограничение: Within 24 hours following each dose, Up to Week 80

A TEAE was defined as an AE that first occurred or worsened after initiation of study drug, with onset assessed within 24 hours following the dosing.
Within 24 hours following each dose, Up to Week 80
Part A and B: Number of Participants With TEAEs Leading to Study Discontinuation
Временное ограничение: Up to Week 80

A TEAE was defined as an AE that first occurred or worsened after initiation of study drug that led to discontinuation of study.
Up to Week 80
Part A and B: Change From Baseline in Hematology Parameters - Absolute Neutrophil Count, Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameters: Absolute Neutrophil Count, Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Hematology Parameter - Erythrocytes
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameter Erythrocytes. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Hematology Parameters - Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameters: Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Hematology Parameter - Erythrocyte Mean Corpuscular Hemoglobin
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameters: Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Hematology Parameters - Erythrocyte Mean Corpuscular Volume
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameter Erythrocyte Mean Corpuscular Volume. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Hematology Parameters - Hematocrit
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of hematology parameter Hematocrit. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase (ALT), Aldolase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Aspartate Aminotransferase (AST)
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameters: ALT, Aldolase, AST, GGT and Lactate Dehydrogenase. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Blood Chemistry Parameters - Albumin and Protein
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameters Albumin and Protein. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase and Creatine Kinase (CK)
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameters Alkaline Phosphatase and CK. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Blood Chemistry Parameters - Bicarbonate, Calcium, Chloride, Glucose, Potassium, Sodium and Urea
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameters: Bicarbonate, Calcium, Chloride, Glucose, Potassium, and Urea. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Blood Chemistry Parameters - Bilirubin, Creatinine and Urate
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameters: Bilirubin, Creatinine, and Urate. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Urinalysis Parameter - pH
Временное ограничение: Baseline (Day 1) to Week 76

Urine samples were collected for the analysis of Urinalysis parameter: pH. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Urinalysis Parameter- Specific Gravity
Временное ограничение: Baseline (Day 1) to Week 76

Urine samples were collected for the analysis of Urinalysis parameters- specific gravity. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Complement Parameters - C3 and C4
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of complement parameters included C3 and C4. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in Complement Parameters - Hemolytic Complement Filtration (CH50)
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of complement parameter- hemolytic complement filtration (CH50). Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in C Reactive Protein (CRP)
Временное ограничение: Baseline (Day 1) to Week 76

Blood samples were collected for the analysis of blood chemistry parameter- CRP. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Number of Participants With Clinically Significant Changes in Vital Signs
Временное ограничение: Up to Week 76

Vital signs were planned to be measured after 5 minutes of rest and taken in the same position throughout the study. Vital signs included blood pressure, pulse, temperature, and respiration rate. Clinically significant changes in vital signs were defined according to protocol-specified criteria for abnormal values (or clinically significant worsening from baseline) as determined by the Investigator.
Up to Week 76
Part A and B: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Временное ограничение: Baseline (Day 1) to Week 76

Triplicate 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Changes in ECG parameters were defined according to protocol-specified criteria for change from baseline values as determined by the Investigator. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-baseline visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and Interval Corrected Using Fridericia's Formula (QTcF) Interval
Временное ограничение: Baseline (Day 1) to Week 76

Triplicate 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Changes in ECG parameters were defined according to protocol-specified criteria for change from baseline values as determined by the Investigator. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) to Week 76
Part A and B: Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Временное ограничение: Up to Week 80

An AE was defined as any untoward medical occurrence in any participant partaking in a clinical investigation, regardless of the suspected cause. An AE was therefore can be any unfavorable and unintended sign, symptom, disease, concurrent illness, or clinically significant abnormal laboratory finding that emerged or worsened during the study. AESIs included injection site reactions, systemic injection reactions (e.g., hypersensitivity, systemic inflammatory response), and infection.
Up to Week 80
Part A and B: Mean Change From Baseline in the Manual Muscle Testing - 12 (MMT-12) Score at Week 76
Временное ограничение: Baseline (Day 1) and up to Week 76

Manual Muscle Testing - 12 assessed the muscle strength across the muscle groups that included neck flexion and both right and left shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist flexion, flexor pollicis longus, hip flexors, hip abduction, hip extension, knee extension, and ankle dorsiflexion. Scores were calculated by summing the outcomes, with the Investigator providing the score, on a scale of 0 (no contraction) to 5 (normal strength), which is then converted by a standard procedure to a Kendall score equivalent on a scale of 0 to 10. Individual scores are summed to generate a total score ranging from 0 to 60. A higher score reflects better muscle strength. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and up to Week 76
Part A and B: Mean Change From Baseline in the Hand Grip Strength Score by Dynamometry at Week 76
Временное ограничение: Baseline (Day 1) and up to Week 76

Grip strength was assessed using a handheld dynamometer which provided a precise measurement of the force that a muscle can exert and reflects muscle strength of the hand. Positive values indicated increased grip strength and negative values indicated decreased grip strength. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and up to Week 76
Part A and B: Mean Change From Baseline in the Quadriceps Strength Score by Dynamometry at Week 76
Временное ограничение: Baseline (Day 1) and up to Week 76

Quadriceps strength was measured using a dynamometer which provided the applied force of leg extension and reflects muscle strength of the dominant leg. Positive values indicated increased strength and negative values indicated decreased strength. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and up to Week 76
Part A and B: Mean Change From Baseline in Modified Timed Up and Go Test (mTUG) at Week 76
Временное ограничение: Baseline (Day 1) and up to Week 76

The mTUG assessed functional mobility by measuring the time required for a participant to rise from a standard armchair, walk 3 meters, turn around, walk back to the chair, and sit down (assistive devices permitted after standing, but no support from a caregiver, or a wall). Negative values indicated faster performance and positive values indicated slower performance. Baseline value was defined as the last non-missing valid value prior to first administration of study treatment (on Day 1). Change from Baseline was calculated as the data collected at post-randomization visits minus the Baseline.
Baseline (Day 1) and up to Week 76

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Abcuro, Inc.

Соавторы

Syneos Health

Публикации и полезные ссылки

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

Полезные ссылки

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 (Действительный)

28 февраля 2023 г.

Первичное завершение (Действительный)

6 ноября 2025 г.

Завершение исследования (Действительный)

27 ноября 2025 г.

Даты регистрации исследования

Первый отправленный

1 февраля 2023 г.

Впервые представлено, что соответствует критериям контроля качества

1 февраля 2023 г.

Первый опубликованный (Действительный)

10 февраля 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ABC008-IBM-201

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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. .

Подписаться