Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06450886




Registration number
NCT06450886
Ethics application status
Date submitted
4/06/2024
Date registered
10/06/2024
Date last updated
5/12/2024

Titles & IDs
Public title
Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis
Scientific 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
Secondary ID [1] 0 0
ABC008-IBM-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inclusion Body Myositis (IBM) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ulviprubart (ABC008)

Experimental: Ulviprubart (ABC008) 2.0 mg/kg SC - 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.


Treatment: Drugs: Ulviprubart (ABC008)
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoint
Timepoint [1] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [1] 0 0
Treatment Emergent Serious Adverse Events (TEASAEs)
Timepoint [1] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [2] 0 0
Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.
Timepoint [2] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [3] 0 0
Adverse Events of Special Interest (AESI)
Timepoint [3] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [4] 0 0
Change from baseline standard laboratory parameters (Hematology)
Timepoint [4] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [5] 0 0
Change from baseline in standard laboratory parameters (Chemistry)
Timepoint [5] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [6] 0 0
Change from baseline in standard laboratory parameters (Coagulation)
Timepoint [6] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [7] 0 0
Inclusion Body Myositis Functional Rating Scale (IBMFRS)
Timepoint [7] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [8] 0 0
Manual Muscle Test 12 (MMT 12)
Timepoint [8] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [9] 0 0
Change from baseline in standard vital signs (respiratory rate)
Timepoint [9] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [10] 0 0
Change from baseline in standard vital signs blood pressure
Timepoint [10] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [11] 0 0
Change from baseline in standard vital signs (temperature)
Timepoint [11] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [12] 0 0
Change from baseline in standard vital signs (pulse rate)
Timepoint [12] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [13] 0 0
Counts of absolute and KLRG1+ lymphocytes by flow cytometry.
Timepoint [13] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [14] 0 0
Presence and titer of antidrug antibodies (ADA)
Timepoint [14] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]
Secondary outcome [15] 0 0
Serum concentration of ulviprubart
Timepoint [15] 0 0
From Baseline (Day 1) through study completion, an average of 156 weeks.]

Eligibility
Key inclusion criteria
* 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2029
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,Washingto
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abcuro, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
6103102271
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06450886