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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Abcuro Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

25 Aug 2025 → ongoing

Decision date (initial)

2025-04-11

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Abcuro Inc.

External identifiers

EU CT number

2024-517623-39-00

ClinicalTrials.gov

NCT06450886

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacodynamic, Pharmacokinetic

Assess the long-term safety and tolerability of ulviprubart (ABC008) in subjects with inclusion.

Secondary objectives 1

1. Assess the long-term efficacy of ulviprubart in subjects with IBM.

Conditions and MedDRA coding

inclusion body myositis

Regulatory references

Plan to share IPD

Yes

IPD plan description

The Sponsor, people and companies working with or for the Sponsor for the purpose of this study, and the regulatory or government agencies worldwide, may have access to deidentified individuals clinical trial patient level data.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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.

Exclusion criteria 4

1. 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.
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).

Secondary endpoints 6

1. Safety:Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs)
2. Safety: Incidence of TEAEs leading to study medication or study discontinuation
3. Safety: Clinically significant changes in standard laboratory parameters and vital signs
4. Safety: Adverse events of special interest (AESIs),
5. Efficacy: Mean change from Baseline (Day 1) in IBMFRS over the duration of the study.
6. Efficacy: Mean change from Baseline (Day 1) in MMT 12 over the duration of the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abcuro Inc.

Sponsor organisation

Abcuro Inc.

Address

55 Chapel Street Suite 200

City

Newton

Postcode

02458-1070

Country

United States

Scientific contact point

Organisation

Abcuro Inc.

Contact name

Garry Weems

Public contact point

Organisation

Abcuro Inc.

Contact name

Ken Cooper

Third parties 8

Locations

3 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications