Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse til evaluering af effektiviteten og sikkerheden af ​​ABC008 for inklusionslegememyositis

8. september 2026 opdateret af: Abcuro, Inc.

En fase II/III randomiseret, dobbeltblind, placebokontrolleret, multicenterundersøgelse til evaluering af effektiviteten og sikkerheden af ​​ABC008 i behandlingen af ​​forsøgspersoner med inklusionskropsmyositis

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

272

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 0.5 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Medicin: ABC008

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

Part A - ABC008 N=12

Part B - ABC008 N= 67
Medicin: ABC008

Given by subcutaneous injection
Placebo komparator: Placebo

Part A - Placebo N= 6

Part B - Placebo N= 67
Medicin: ABC008

Given by subcutaneous injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A and B: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abcuro, Inc.

Samarbejdspartnere

Syneos Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2023

Primær færdiggørelse (Faktiske)

6. november 2025

Studieafslutning (Faktiske)

27. november 2025

Datoer for studieregistrering

Først indsendt

1. februar 2023

Først indsendt, der opfyldte QC-kriterier

1. februar 2023

Først opslået (Faktiske)

10. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABC008-IBM-201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner