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Inclusion Body Myositis (IBM)Phase 2/3NCT06450886

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

A Phase 2/3 study testing Ulviprubart (ABC008) in people with Inclusion Body Myositis (IBM), run by Abcuro, Inc. at 21 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Inclusion Body Myositis (IBM)
What is being tested?
Ulviprubart (ABC008)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
21 sitesin 2 countries
Study dates
21 Oct 2024to Apr 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures.
  • 2. 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.
  • 3. Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201.
  • 4. 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.
  • 5. 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.
  • 6. WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.
  • 7. 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.

Who cannot join

  • 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.
  • 2. 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.
  • 3. Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study.
  • 4. Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States18 sites

  • Austin Neuromuscular Center

    Austin, Texas, 78759

  • Neuromuscular Diagnostic Center - Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital

    Boston, Massachusetts, 021158

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Texas Neurology

    Dallas, Texas, 75206

  • Duke Neurological Disorders Clinic

    Durham, North Carolina, 27710

  • Virginia Commonwealth University

    Henrico, Virginia, 23233

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Nerve and Muscle Center of Texas

    Houston, Texas, 75206

  • University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center

    Irvine, California, 92868

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale School of Medicine

    New Haven, Connecticut, 06519

  • Hospital for Special Surgery

    New York, New York, 10021

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

Australia3 sites

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • Perron Institute for Neurological and Translational Science

    Nedlands, Washington, 6009

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official 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

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.
Read the detailed description

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.

Being tested
Ulviprubart (ABC008)
Medical subject headings
Myositis, Inclusion Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06450886
Study groupRoleWhat they receive
Ulviprubart (ABC008) 2.0 mg/kg SCExperimentalAll 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.
Receives: Drug: Ulviprubart (ABC008)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

    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)

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

Secondary outcomes (15)

  1. Treatment Emergent Serious Adverse Events (TEASAEs)

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

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

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

    Incidence of TEAEs leading to study medication or study discontinuation

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

  3. Adverse Events of Special Interest (AESI)

    Incidence of Adverse events of special interest (AESIs)

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

  4. Change from baseline standard laboratory parameters (Hematology)

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

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

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

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

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

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

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

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

  7. Inclusion Body Myositis Functional Rating Scale (IBMFRS)

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

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

  8. Manual Muscle Test 12 (MMT 12)

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

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

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

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

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

  10. Change from baseline in standard vital signs blood pressure

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

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

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

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

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

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

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

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

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

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

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

  14. Presence and titer of antidrug antibodies (ADA)

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

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

  15. Serum concentration of ulviprubart

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2024
  2. Study start21 Oct 2024
  3. Primary completionJan 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06450886
Sponsor's protocol ID
ABC008-IBM-202
Status last verified
Oct 2024
First submitted
4 Jun 2024
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ulviprubart (ABC008) in people with Inclusion Body Myositis (IBM), run by Abcuro, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: From Baseline (Day 1) through study completion, an average of 156 weeks.]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06450886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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