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Een studie om de werkzaamheid en veiligheid van ABC008 voor Inclusion Body Myositis te evalueren

8 september 2026 bijgewerkt door: Abcuro, Inc.

Een fase II/III gerandomiseerde, dubbelblinde, placebogecontroleerde, multicenter studie om de werkzaamheid en veiligheid van ABC008 te evalueren bij de behandeling van proefpersonen met Inclusion Body Myositis

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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

272

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 0.5 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Geneesmiddel: ABC008

Given by subcutaneous injection
Actieve vergelijker: 2.0 mg/kg ABC008

Part A - ABC008 N=12

Part B - ABC008 N= 67
Geneesmiddel: ABC008

Given by subcutaneous injection
Placebo-vergelijker: Placebo

Part A - Placebo N= 6

Part B - Placebo N= 67
Geneesmiddel: ABC008

Given by subcutaneous injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part A and B: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Abcuro, Inc.

Medewerkers

Syneos Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 februari 2023

Primaire voltooiing (Werkelijk)

6 november 2025

Studie voltooiing (Werkelijk)

27 november 2025

Studieregistratiedata

Eerst ingediend

1 februari 2023

Eerst ingediend dat voldeed aan de QC-criteria

1 februari 2023

Eerst geplaatst (Werkelijk)

10 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ABC008-IBM-201

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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