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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04789070
The ClinicalTrials.gov registry entry for NCT04789070 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (37% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.