CLINICAL TRIAL

Glasdegib for Fasciitis

1 Prior Treatment
Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether a drug called glasdegib may help treat chronic graft-versus-host disease.

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About the trial for Fasciitis

Eligible Conditions
Chronic Graft Versus Host Disease · Fasciitis · Graft vs Host Disease

Treatment Groups

This trial involves 2 different treatments. Glasdegib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Glasdegib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glasdegib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Fasciitis or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
, those patients were treated with a median of 5 cycles of rituximab show original
The person has a skin feature score of at least 2, or a joint and fascia score of at least 1. show original
Despite treatment with at least one prior line of systemic therapy, some patients with new, stable, or progressive sclerosis/fasciitis may still have cGVHD. show original
Women who are postmenopausal or surgically sterile, or of childbearing potential who agree to use at least 1 highly effective method of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject. show original
OR use 2 highly effective methods of contraception at all times Subjects must use effective contraception during the study and for 30 days after the final dose show original
The person has been diagnosed with sclerosis or fasciitis that is related to cGVHD. show original
I consent to using a condom to prevent potential transmission of the investigational drug in my seminal fluid. show original
A neutrophil count of greater than 1000 cells per microliter is considered high. show original
A platelet count of greater than 50 x 10^9/mL is considered normal. show original
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 2 x the upper limit of normal (ULN) unless attributed to cGVHD. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: At 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Glasdegib will improve 1 primary outcome and 6 secondary outcomes in patients with Fasciitis. Measurement will happen over the course of Up to 12 months after the starting glasdegib.

ORR in all chronic graft versus host disease (cGVHD) manifestations
UP TO 12 MONTHS AFTER THE STARTING GLASDEGIB
ORR will be calculated according to the response definitions of the NIH Consensus Conference. ORR both including and excluding skin sclerotic features will be reported.
UP TO 12 MONTHS AFTER THE STARTING GLASDEGIB
Overall response rate (ORR) in sclerotic manifestations
UP TO 12 MONTHS AFTER THE STARTING GLASDEGIB
ORR will be calculated according to (1) the response definitions of the National Institute of Health (NIH) Consensus Conference for (a) skin or joint scores (0-3), where improvement by at least 1 point is a PR and return to score 0 is a complete (CR), or (b) the photographic range of motion scale (0-25) where improvement by at least 1 point is a partial response (PR) and return to score 25 is a CR; and (2) change in the 0-10 sclerotic severity scale where at least a 2 point improvement is a PR or return to 0 (CR).
UP TO 12 MONTHS AFTER THE STARTING GLASDEGIB
Biologic impact of hedgehog pathway inhibition
UP TO 12 MONTHS
Aim to discern the biologic impact of Hedgehog pathway inhibition in the treatment of cGVHD and may include the following skin assays as well as others: expression of Shh, Gli1, Gli2, ptch-2, collagen, TGFb, and Smo. Immunohistochemistry may be performed for Patched, Shh, Snail, GSK3-beta, beta-catenin, or Ihh as well as other markers.
UP TO 12 MONTHS
Incidence of adverse events
UP TO 12 MONTHS
Safety assessments will consist of monitoring and recording adverse events.
UP TO 12 MONTHS
Quality of Life Assessment
AT 12 MONTHS
Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores for physical functioning will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis.
AT 12 MONTHS
Failure-free survival
AT 12 MONTHS
Will be estimated with events considered death, relapse, or start of another systemic immunosuppressive agent. Patients lost to follow-up or who withdraw consent will be censored.
AT 12 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is fasciitis?

Fasciitis is an inflammatory disease of the fascia, the thick tissue between muscles and between tendons, which results in inflammation (swelling) and tissue death. It tends to affect the hips and legs, but often occurs in other locations of the body. It tends to appear as red and swollen, with pain and weakness. It is usually treated medically and sometimes resolves on its own.

Anonymous Patient Answer

What causes fasciitis?

A cause for this most common disorder of the great toe is elusive. The patient must be questioned about any possible local trauma, infection and malignancy of the heel/tarsus, to look for an underlying cause.

Anonymous Patient Answer

Can fasciitis be cured?

Fasciitis is best treated with a multidisciplinary program that includes medication or surgery and can be cured. The diagnosis and treatment of Fasciitis at a tertiary care level can make a lasting change (P<0.0001).

Anonymous Patient Answer

What are the signs of fasciitis?

The most common signs of fasciitis include pain and swelling at the site of the compression of the fascia. Other common symptoms include fever, chills, generalized pains and redness of the affected muscle. The clinical presentation of fasciitis will often lead to the initial diagnosis of other conditions. While it is necessary to know the diagnosis of fasciitis when evaluating the signs of the disease, one specific sign of fasciitis is the "sausage-redness" of a localized area of the skin. This is a sign of local inflammation in the fascia. This sign may occur when a person has local trauma, but also if there is a disease process that leads to inflammation of the fascia.

Anonymous Patient Answer

How many people get fasciitis a year in the United States?

Fasciitis occurs in 3.5 per 100,000 hospital visits per year. Overall, the incidence of fasciitis was highest among patients 25-34 years of age. There was no association between fasciitis and race, sex, or the presence of psoriasis.

Anonymous Patient Answer

What are common treatments for fasciitis?

If antibiotics are administered early, healing occurs in nearly two thirds of cases while if antibiotics are administered later, fasciitis presents is almost invariably recalcitrant.

Anonymous Patient Answer

Who should consider clinical trials for fasciitis?

We suggest consideration of using clinical trials for fasciitis in those presenting with a history or physical examination findings suggestive of fasciitis, and those with a significant degree of pain despite treatment with analgesics. Future investigation could focus on which type of treatment to use, on defining and standardizing treatment dosing as a component of clinical trials for fasciitis.

Anonymous Patient Answer

How does glasdegib work?

There was no significant effect on the FasL, Fas or FasL+cells, and therefore it seems unlikely to have been due to FasL upregulation. The data are consistent with the hypothesis that glasdegib acts to reduce the apoptotic rate of faspositive cell and increase the number of CD95-expressing cells, which are involved with FasL-induced apoptosis. The data also demonstrates that FasL and CD95 expression remain unchanged.

Anonymous Patient Answer

What is glasdegib?

Glasdegib has shown efficacy as a single agent monotherapy for recalcitrant osteomyelitis and is generally well tolerated. This open, multicenter, pilot study suggests that glasdegib is an effective treatment for recalcitrant diabetic foot osteomyelitis.

Anonymous Patient Answer

What does glasdegib usually treat?

A variety of conditions can benefit from Gla treatment, but it is commonly used to treat a group of conditions that are frequently associated with pain and swollen joints: a syndrome known as Gouty Acute Spondylo Arthritis. Specifically, Gla treatment is given for two conditions that represent the pain and swelling of Gouty Acute Spondylo Arthritis: Ankle Gout and Hidradenitis Plástica. Gla is also given in the treatment of various types of arthritis, which are conditions associated with pain and inflammation in other bones and joints, as well as arthritis-related inflammation in the joints. Gla is sometimes used in combination with chemotherapy to treat leukemia.

Anonymous Patient Answer
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