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NCT04789070 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of Sirolimus in IBM
A Phase 3 study of Inclusion Body Myositis, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 10
- Study locations
NCT04789070: Active Phase 3 study of Inclusion Body Myositis, sponsored by University of Kansas Medical Center.
NCT04789070 is a Phase 3 study of Inclusion Body Myositis that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 140 participants, below the 222-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (37% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789070, a Phase 3 study of Inclusion Body Myositis, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 10
- Study locations
Study Summary
The hypothesis is that Sirolimus, (Rapamycin (R)) which is currently used in organ transplantation and works by blocking the activity of T effector cells but preserving T regulatory cells, as well as by inducing autophagy (protein degradation), will be effective in IBM to slow or stabilize disease progression, helping to maintain patient function and independence. This phase III trial will confirm pilot data showing statistically significant clinical outcomes.
Primary Outcome
The IBM-FRS is a concise and quick (\~10 minute), clinician-administered ordinal rating scale used to determine participants' assessment of their capability and independence. It includes 10 measures (swallowing, handwriting, cutting food and handling utensils, fine motor tasks, dressing, hygiene, turning in bed and adjusting covers, changing position from sitting to standing, walking, and climbing stairs), graded on a Likert scale from 0 (being unable to perform) to 4 (normal). The sum of the 10
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Placebo
Study Locations (10)
New South Wales
- Concord Repatriation Hospital - Sydney
- Royal Northshore Hospital - Sydney
Victoria
- Austin Health - Melbourne
- St Vincent's Hospital - Melbourne
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Johns Hopkins University - Baltimore
Queensland
- Royal Brisbane and Women's Hospital - Brisbane
South Australia
- Royal Adelaide Hospital - Adelaide
Washington
- Perron Institute - Perth
Other
- Leiden University Medical Center - Leiden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What the registry record for NCT04789070 still lists
NCT04789070 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 222-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Inclusion Body Myositis appearing as the primary indexed condition, and to 2 interventions - of which Sirolimus is the first listed.
NCT04789070 lists 10 locations in 8 states (New South Wales, Victoria, Kansas).
Frequently Asked Questions
What is clinical trial NCT04789070 about?
NCT04789070 is a clinical study titled "Phase III Trial of Sirolimus in IBM". The hypothesis is that Sirolimus, (Rapamycin (R)) which is currently used in organ transplantation and works by blocking the activity of T effector cells but preserving T regulatory cells, as well as by inducing autophagy (protein degradation), will be effective in IBM to slow or stabilize disease p...
What is the current status of trial NCT04789070?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2022-07-01. Estimated completion is 2027-12.
What conditions does trial NCT04789070 study?
This clinical trial studies the following conditions: Inclusion Body Myositis.
What interventions are being tested in trial NCT04789070?
The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG).
Who is sponsoring clinical trial NCT04789070?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04789070 being conducted?
This trial has 10 study locations across Kansas, Maryland, New South Wales, Queensland, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04789070's enrollment target sits among peer trials
140 4th of 10 higher than 7 of 10 other Inclusion Body Myositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inclusion Body Myositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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