A Phase 1 interventional study of Pioglitazone in Myositis, Inclusion Body Myositis and Muscular Diseases, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
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Among 37 studies in Myositis, Inclusion Body with a site in United States — 4 open to participants now, 9 under way, 2 of them phase 3. Myositis, Inclusion Body · United States.
Among the 37 studies in Myositis, Inclusion Body with a site in United States, this one is the 18th largest by enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2018, is one of 7 in phase 1, and was the 22nd registered.
65 studies on the registry are indexed under Myositis, Inclusion Body; 10 are open to participants now.
Browse Myositis, Inclusion Body studies →4 of the 37 studies in Myositis, Inclusion Body with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18+ · Healthy volunteers
Myositis International Health & Research Collaborative Alliance Foundation · Sites in United States
Ages 7+
Austin Neuromuscular Center · Sites in United States
Ages 45–75
National Institute of Environmental Health Sciences (NIEHS) · Sites in United States
Ages 2–100 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Myositis, Inclusion Body studies recruiting now, 4 set no upper age limit and 1 stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
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37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 13 · Phase 3 9
First in 1990; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 30 across 42 interventional studies indexed under Myositis, Inclusion Body.
Median enrollment 24 across the 27 interventional studies, 59 across the 10 observational. Of the 26 that completed or were terminated, 11 (42%) have results posted.
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11 of 37 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 2 studies filed under Myositis, Inclusion Body — fewer than ten, so there is no comparison to draw.
2 of the studies in Myositis, Inclusion Body with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05046821University of California, IrvineSporadic Inclusion Body Myositis Natural History Study | 2027-03-31 |
| NCT06479863Austin Neuromuscular CenterEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis | 2027-05-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 37 studies in Myositis, Inclusion Body with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic inclusion body myositis (sIBM).
This is a 52-week, Phase 1, open-label, single center, proof of concept study of FDA-approved pioglitazone in adult patients with sporadic inclusion body myositis (sIBM). The trial consists of a 4-week screening period;16-week "lead-in" period during which all subjects are observed off-treatment. At Week 16, all subjects will be started on pioglitazone at a dose of 30 mg daily. The dose will be uptitrated to a goal dose of 45 mg daily after 2 weeks; 32-week treatment period with all subjects on 45 mg daily dose of pioglitazone.
65 studies on the registry are indexed under Myositis, Inclusion Body; 10 are open to participants now.
This study's enrollment of 19 is below the median of 30 across 42 interventional studies indexed under Myositis, Inclusion Body.
Browse Myositis, Inclusion Body studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Myositis, Inclusion Body, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will be provided Pioglitazone 15mg tablets, total dose of 45mg (3 tablets) for oral administration once daily. 32-week treatment period.
Drug: Pioglitazone
Pioglitazone comes as a tablet to take by mouth and can be taken with or without food.
Also known as: Actos
Change from baseline in Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target gene expression
Effect of 45 milligram pioglitazone dose on the expression of Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target genes
Time frame: 4 weeks, 16 weeks, 32 weeks after baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Dec 2020, 31 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pioglitazone