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Badanie mające na celu ocenę skuteczności i bezpieczeństwa ABC008 w zapaleniu mięśni ciałek wtrętowych

8 września 2026 zaktualizowane przez: Abcuro, Inc.

Randomizowane, wieloośrodkowe badanie fazy II/III z podwójnie ślepą próbą, kontrolowane placebo, oceniające skuteczność i bezpieczeństwo ABC008 w leczeniu pacjentów z wtrętowym zapaleniem mięśni

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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

272

Faza

  • Faza 2
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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;

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 0.5 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Lek: ABC008

Given by subcutaneous injection
Aktywny komparator: 2.0 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Lek: ABC008

Given by subcutaneous injection
Komparator placebo: Placebo

Part A - Placebo N= 6

Part B - Placebo N= 67
Lek: ABC008

Given by subcutaneous injection

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Part A and B: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Abcuro, Inc.

Współpracownicy

Syneos Health

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 lutego 2023

Zakończenie podstawowe (Rzeczywisty)

6 listopada 2025

Ukończenie studiów (Rzeczywisty)

27 listopada 2025

Daty rejestracji na studia

Pierwszy przesłany

1 lutego 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 lutego 2023

Pierwszy wysłany (Rzeczywisty)

10 lutego 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ABC008-IBM-201

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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