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ABC008 for Inclusion Body Myositis
Phase 2 & 3
Waitlist Available
Research Sponsored by Abcuro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) through study completion, an average of 80 weeks.
Awards & highlights
Study Summary
This trial tests a new drug to see if it can treat Inclusion Body Myositis, a muscle disorder. It is a big, carefully designed study to see how safe and effective the drug is.
Who is the study for?
This trial is for adults over 40 with Inclusion Body Myositis who can walk and rise from a chair unassisted. They must weigh between 40-150 kg and meet specific diagnostic criteria. Excluded are those with other myopathies, severe arthritis affecting assessments, or autoimmune diseases like lupus or rheumatoid arthritis.Check my eligibility
What is being tested?
The study tests ABC008's effectiveness and safety in treating Inclusion Body Myositis. Participants will be randomly assigned to receive either ABC008 or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Potential side effects of ABC008 aren't specified here but typically include reactions at the injection site, general discomfort, possible immune system responses, or other drug-specific effects that would be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day 1) through study completion, an average of 80 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) through study completion, an average of 80 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A - To determine the safety and tolerability of recurrent dosing of ABC008 in subjects with IBM at 2 SC dose levels.
Part B - To determine the efficacy of ABC008 in IBM at two SC dose levels as measured by IBM Functional Rating Scale (IBMFRS) at Week (W)76
Secondary outcome measures
Part A - Adverse Events of Special Interest (AESI)
Part A - Clinically significant changes in standard laboratory parameters, vital signs, and ECGs
Part A - Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.
+6 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: 2.0 mg/kg ABC008Active Control1 Intervention
Part A - ABC008 N=12
Part B - ABC008 N= 67
Group II: 0.5 mg/kg ABC008Active Control1 Intervention
Part A - ABC008 N=12
Part B - ABC008 N= 67
Group III: PlaceboPlacebo Group1 Intervention
Part A - Placebo N= 6
Part B - Placebo N= 67
Find a Location
Who is running the clinical trial?
Abcuro, Inc.Lead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
Syneos HealthOTHER
172 Previous Clinical Trials
68,223 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk 3 meters and sit down by myself, using aids if needed but without another person's help.I have been diagnosed with IBM as per ENMC criteria and have histopathology results.I have a condition that makes it hard to measure my muscle strength or do physical tests.I am over 40 years old.My weight is between 40 and 150 kg.I can get up from a chair using my arms but without help or a device.I have an autoimmune disease but it's not severe and under control.I do not have any muscle conditions other than IBM.I can get up from a chair using my arms but without help or a device.My weight is between 40 and 115 kg.I am over 40 years old.I can walk 3 meters and sit down without help from another person.I have been diagnosed with IBM according to ENMC criteria and have the necessary test results.
Research Study Groups:
This trial has the following groups:- Group 1: 2.0 mg/kg ABC008
- Group 2: 0.5 mg/kg ABC008
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Inclusion Body Myositis Patient Testimony for trial: Trial Name: NCT05721573 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for participants in this research?
"Per the records available on clinicaltrials.gov, this trial is still searching for enrollees. The initial publication of the research was February 28th 2023 with a subsequent update occurring March 8th in the same year."
Answered by AI
How many healthcare centers are participating in the trial currently?
"Nine clinical trial sites, including those located in New Haven, Boston and New york are currently participating. Prospective participants should prioritize the closest location to minimize required travelling for their participation."
Answered by AI
What is the aggregate number of participants involved with this trial?
"Abcuro, Inc., the trial sponsor, intends to enroll 231 eligible patients at two of its sites: Yale School of Medicine in New Haven and Neuromuscular Diagnostic Center - Massachusetts General Hospital in Boston."
Answered by AI
What is the aim of this clinical experiment?
"From baseline to the end of the trial, which will last approximately 76 weeks, researchers are primarily interested in assessing ABC008's safety and tolerability when taken recurrently by IBM patients at two dose levels. Secondary objectives include measuring changes in quadriceps strength via dynamometry, recording treatment-emergent adverse events within 24 hours post-administration of study medications, and counting occurrences of side effects that necessitate discontinuation from the trial."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Pennsylvania
What site did they apply to?
Yale School of Medicine
Hospital for Special Surgery
University of Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
Why did patients apply to this trial?
I am looking for help in slowing or curing this disease. At this time there is no action that one can take to delay or improve symptoms.
PatientReceived 2+ prior treatments
Diagnosed with IBM 8 years ago. Live in Tampa and Jacksonville is driving distance.
PatientReceived no prior treatments
I have been dealing with IBM a number of years. It was Penn that first diagnosed my IBM, but at that time Penn had no specialists looking into IBM. I transferred doctors to John Hopkins. I am a Penn heart transplant patient.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What are the eligibility requirements?
PatientReceived no prior treatments
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