ULVIPRUBART for Inclusion body myositis

Inclusion criteria

• {"criterion_text":"- Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures"}
• {"criterion_text":"- Has participated in and completed either Study ABC008-IBM-101 or Study ABC008-IBM-201; completion of the prior study will be defined as completion of the Part 2 (MAD) EOT Visit in Study ABC008-IBM-101 (subjects may have continued into Part 3 [MAD Extension]) or completion of the Week 80 Follow-up Visit in Study ABC008-IBM-201."}
• {"criterion_text":"- Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201"}
• {"criterion_text":"- Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections of ulviprubart."}
• {"criterion_text":"- Women of childbearing potential (WOCBP) and male subjects with female partners who are WOCBP (based on sex assignation at birth) must agree to use highly effective (< 1% failure rate) contraception for the duration of the study through 180 days after EOT/ETV."}
• {"criterion_text":"- WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit."}
• {"criterion_text":"- Male subjects (based on sex assignation at birth) must refrain from sperm donation for the duration of the study through 180 days after EOT/ETV."}

Exclusion criteria

• {"criterion_text":"- Has an unresolved clinically significant AE or a clinically significant finding on a clinical laboratory test, electrocardiogram, or physical examination during Study ABC008-IBM-101 or Study ABC008-IBM-201 that, in the Investigator’s opinion, would limit the subject’s ability to participate in or comply with this study."}
• {"criterion_text":"- Participation in another investigational drug study (other than Study ABC008-IBM-101 or Study ABC008-IBM-201) within 30 days prior to the Baseline (Day 1) Visit or five times the half-life of the investigational drug, whichever is longer."}
• {"criterion_text":"- Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study"}
• {"criterion_text":"- Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).","definition_or_measurement_approach":"Incidence, type and severity of treatment-emergent adverse events (TEAEs) as reported during the study."}

Secondary endpoints

• {"endpoint_text":"- Safety:Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs)","definition_or_measurement_approach":"Incidence, type, and severity of treatment-emergent serious adverse events collected during the study."}
• {"endpoint_text":"- Safety: Incidence of TEAEs leading to study medication or study discontinuation","definition_or_measurement_approach":"Incidence of TEAEs that result in study medication interruption or subject discontinuation."}
• {"endpoint_text":"- Safety: Clinically significant changes in standard laboratory parameters and vital signs","definition_or_measurement_approach":"Assessment of clinically significant changes from baseline in standard laboratory tests and vital signs."}
• {"endpoint_text":"- Safety: Adverse events of special interest (AESIs),","definition_or_measurement_approach":"Identification and reporting of predefined adverse events of special interest during the study."}
• {"endpoint_text":"- Efficacy: Mean change from Baseline (Day 1) in IBMFRS over the duration of the study.","definition_or_measurement_approach":"Mean change from baseline in IBM Functional Rating Scale (IBMFRS) assessed over the study duration."}
• {"endpoint_text":"- Efficacy: Mean change from Baseline (Day 1) in MMT 12 over the duration of the study","definition_or_measurement_approach":"Mean change from baseline in Manual Muscle Test (MMT) 12 score assessed over the study duration."}

Belgium

Earliest CTIS Part Ii Submission Date

19-03-2025

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

4

France

Earliest CTIS Part Ii Submission Date

14-03-2025

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

28

Number Of Sites

1

Number Of Participants

5

Germany

Earliest CTIS Part Ii Submission Date

24-03-2025

Latest Decision Or Authorization Date

16-04-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

4

Primary sponsor

Full Name

Abcuro Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PCI Pharma Services Germany GmbH

Responsibilities

code 14

Name

Suvoda LLC

Responsibilities

code 3

Name

Medidata Solutions Inc.

Responsibilities

codes 6, 7

Name

Longboat Clinical Limited

Responsibilities

15: Electric platform for rater qualification and rater training

Name

Syneos Health UK Limited

Responsibilities

codes 1,10,11,12,13,15 (15: Vendor Management),2,5,6,7,8,9

Name

Iqvia Laboratories Limited

Responsibilities

code 4

Name

BioAgilytix Europe GmbH

Responsibilities

code 4

Name

B2s Life Sciences LLC

Responsibilities

code 4

Third parties

• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes 6, 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"15: Electric platform for rater qualification and rater training","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"B2s Life Sciences LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"codes 1,10,11,12,13,15 (15: Vendor Management),2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}