Your session is about to expire
← Back to Search
Sirolimus for Inclusion Body Myositis
Phase 3
Recruiting
Led By Mazen Dimachkie
Research Sponsored by University of Kansas Medical Center
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 baseline, week 84
Awards & highlights
Study Summary
This trial will test if a drug already used in organ transplantation, called Sirolimus (Rapamycin (R)), can help to slow or stabilize disease progression in IBM patients, helping them to maintain function and independence.
Who is the study for?
Adults aged 45+ with Inclusion Body Myositis (IBM) who can walk at least 200m with or without aids and have shown disease progression in the past year. Participants must understand the study, consent to it, not have used Sirolimus recently, be HIV and hepatitis negative, not pregnant or planning pregnancy, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if Sirolimus can slow down IBM's progress compared to a placebo. It's based on earlier results suggesting benefits from Sirolimus due to its effects on immune cells and protein degradation. Patients will be randomly assigned either the drug or a placebo for comparison.See study design
What are the potential side effects?
Sirolimus may cause side effects like increased risk of infections due to immune system suppression, potential kidney or liver issues, high cholesterol levels, low blood cell counts which could lead to fatigue or bleeding problems, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 84
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in IBM Functional Rating Scale (IBM-FRS) from Baseline to Week 84
Secondary outcome measures
Change in 6 Minute Walk Test (6MWT) from Baseline to Week 84
Change in Manual Muscle Testing (MMT) from Baseline to Week 84
Change in Modified Timed Up and Go (mTUG) from Baseline to Week 84
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SirolimusActive Control1 Intervention
2mg capsules once daily
Group II: PlaceboPlacebo Group1 Intervention
2mg capsules once daily
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
460 Previous Clinical Trials
168,975 Total Patients Enrolled
The Perron InstituteUNKNOWN
Mazen DimachkiePrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken Sirolimus or Everolimus in the last 6 months.You do not have HIV, Hepatitis C, or certain markers for Hepatitis B.Your condition has gotten worse in the past year, as confirmed by a neuromuscular specialist through various tests and examinations.You cannot walk at least 200 meters during a six-minute walk test.You are allergic to Sirolimus or Everolimus.You have a history, examination, or tests that suggest you have moderate or severe breathing problems, and your forced vital capacity (FVC) is less than half of what it should be. You are allowed to use a machine to help you breathe while you sleep if you have sleep-related breathing issues.Your blood tests show very high cholesterol or triglycerides, or low levels of hemoglobin, platelets, neutrophils, or lymphocytes.You are a man or woman who is 45 years old or older.You have severe kidney disease with protein in your urine.You can walk at least 200 meters in 6 minutes, even if you need to use walking aids like frames.You have chronic liver disease or very high levels of liver enzymes, unless it's due to a muscle-related issue. If your liver enzymes are temporarily high due to something like a viral infection, you can be screened again later.You have had any type of cancer, except for skin cancers that were only in one area, in the past 5 years.You have an autoimmune disease that is not under control and requires ongoing treatment. This includes conditions like Graves' disease.You are taking medications that weaken or change your immune system.You are taking certain medications that may interact with sirolimus. Also, you are not taking any other experimental drugs besides the study medication.You have been diagnosed with IBM using specific criteria from 2011.You can walk at least 200 meters within 6 minutes, and you can use walking aids like frames if needed.You are 45 years old or older.Your condition has gotten worse in the past year, according to a specialist and certain tests.
Research Study Groups:
This trial has the following groups:- Group 1: Sirolimus
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being recruited for this clinical trial?
"That is correct. The clinicaltrials.gov site says that this study, which was first advertised on July 1st, 2022, is still looking for participants. They need to find 140 people total between 2 hospitals or clinics."
Answered by AI
Are new volunteers being accepted for this research program?
"Yes, that is accurate. The clinical trial in question is actively recruiting patients, as stated on the website clinicaltrials.gov. This specific study was originally posted on July 1st, 2022 and was edited October 12th of the same year. A total of 140 patients are being recruited from 2 sites."
Answered by AI
How is Sirolimus most often employed?
"Sirolimus has shown efficacy in treating transplant rejection, liver disease, and kidney disease."
Answered by AI
Does the FDA sanction the use of Sirolimus?
"Sirolimus has been studied in Phase 3 clinical trials, demonstrating some efficacy and supporting multiple rounds of data that suggest it is safe."
Answered by AI
Has Sirolimus been looked at under a microscope before?
"Currently, there are one hundred and thirty clinical trials involving sirolimus with thirteen of those in Phase 3. Although a few of the tests are taking place in Cincinnati, Ohio, there are 1084 locations worldwide running clinical trials for sirolimus."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am a transplant patient and have been taking sirolimus a few years.
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger