A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

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).

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.

A TEAE was defined as an AE that first occurred or worsened after initiation of study drug that led to discontinuation of study.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.