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NCT Number: NCT06450886

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis

ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:

* Have completed the Part 2 (Multiple Ascending Dose [MAD]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR * Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Inclusion Body Myositis (IBM) Muscular Diseases Musculoskeletal Diseases Myositis Myositis, Inclusion Body Nervous System Diseases Neuromuscular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal North Shore Hospital, Saint Leonards, New South Wales, Australia

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About this study

ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:

  • Have completed the Part 2 (Multiple Ascending Dose [MAD]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR
  • Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201. Subjects will enter this study following their initial study such that dosing continues every eight weeks (Q8W) between the last dose in the initial study and the first dose in this long-term extension (LTE) Study IBM-202. Study subjects will continue to receive any ongoing concomitant medications from the initial study.

Subjects will be required to sign an informed consent form before undertaking any study-specific procedures or assessments. Screening is intended to be done at the final visit of the initial study, which will coincide with the Baseline (Day 1) Visit for this study; if this is not possible, the Baseline (Day 1) Visit for this study, including screening, may be conducted at a separate visit (provided it occurs within the visit window defined in Appendix 1 of the protocol). Subsequent study visits will occur every eight weeks until EOT at Week 156, or withdrawal from the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures.
  • 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.
  • Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201.
  • 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.
  • 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.
  • WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.
  • 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

  • 1. Has an unresolved clinically significant AE or a clinically significant finding on a clinical laboratory test, ECG, 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.
  • 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.
  • Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study.
  • Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study.

Treatment and study plan

Ulviprubart (ABC008)

Drug

All eligible subjects, regardless of treatment assignment or dose level in their initial study, will be administered ulviprubart at a dose of 2.0 mg/kg via subcutaneous (SC) injection Q8W.

Primary outcomes

  1. Primary Endpoint

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs)

Secondary outcomes

  1. Treatment Emergent Serious Adverse Events (TEASAEs)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs)

  2. Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of TEAEs leading to study medication or study discontinuation

  3. Adverse Events of Special Interest (AESI)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of Adverse events of special interest (AESIs)

  4. Change from baseline standard laboratory parameters (Hematology)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes in standard laboratory parameters (Hematology)

  5. Change from baseline in standard laboratory parameters (Chemistry)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes from baseline in standard laboratory parameters (Chemistry)

  6. Change from baseline in standard laboratory parameters (Coagulation)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes from baseline standard laboratory parameters (Coagulation)

  7. Inclusion Body Myositis Functional Rating Scale (IBMFRS)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Mean change from Baseline (Day 1) in IBMFRS over the duration of the study

  8. Manual Muscle Test 12 (MMT 12)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Mean change from Baseline (Day 1) in MMT 12 over the duration of the study

  9. Change from baseline in standard vital signs (respiratory rate)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes in vital signs (respiratory rate)

  10. Change from baseline in standard vital signs blood pressure

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes in standard vital signs blood pressure (Systolic and diastolic) blood pressure)

  11. Change from baseline in standard vital signs (temperature)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes in standard vital signs (temperature)

  12. Change from baseline in standard vital signs (pulse rate)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Incidence of clinically significant changes in standard vital signs (pulse rate)

  13. Counts of absolute and KLRG1+ lymphocytes by flow cytometry.

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Blood samples will be collected for immunophenotyping. Counts of absolute and KLRG1+ lymphocytes and other lymphocyte subsets will be performed by flow cytometry.

  14. Presence and titer of antidrug antibodies (ADA)

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    The incidence and titers of ADAs to ulviprubart will be evaluated in blood samples

  15. Serum concentration of ulviprubart

    Time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]

    Individual and mean serum concentration time profiles will be presented graphically using nominal time points.

Sponsors and collaborators

Lead sponsor

Abcuro, Inc.

Industry

Registry information

Official study title

An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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