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Senolytic
Fisetin for Immune Deficiency-Related Lung Disease
Phase 2
Waitlist Available
Led By Avni Joshi, MD, MS
Research Sponsored by Avni Joshi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physician diagnosis of possible GLILD associated with CVID
Be older than 18 years old
Must not have
Patient currently hospitalized or under immediate consideration for hospitalization
Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Summary
This trial is testing whether a natural supplement called Fisetin can help people with common variable immunodeficiency (CVID). CVID patients often struggle with infections due to a weak immune system. Fisetin might help by reducing inflammation and strengthening their immune response.
Who is the study for?
This trial is for adults with Common Variable Immunodeficiency (CVID) and associated lung disease, who have been diagnosed according to international standards. Participants must not be pregnant or at risk of pregnancy without contraception, should not use tobacco or consume excessive caffeine, and must be capable of following the study's procedures.
What is being tested?
The trial is testing Fisetin, a dietary supplement, against a placebo to see if it can treat interstitial lung disease in patients with CVID. The effectiveness of Fisetin will be compared to that of an inactive substance to determine its potential as a treatment option.
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions typical for dietary supplements which could include digestive discomfort, allergic reactions or other symptoms depending on individual tolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor thinks I might have lung disease due to common variable immune deficiency.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in the hospital or might need to be hospitalized soon.
Select...
I am a man who agrees to use contraception or abstain from sex with women who can become pregnant, from the start of the treatment until 48 hours after the last dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
Adverse Events
Change in 6 minute walk test
Vital capacity
+4 moreSide effects data
From 2023 Phase 1 & 2 trial • 75 Patients • NCT0421098638%
Arthralgia
15%
Pain in Extremity
12%
Nausea
12%
Lab Findings
9%
Back Pain
9%
Fatigue
9%
Headache
6%
Flatulence
6%
Muscle Cramp
6%
Dry Mouth
6%
Rash Maculo-Papular
3%
Bladder Perforation
3%
Covid 19
3%
Neoplasms
3%
Rotator Cuff Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fisetin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fisetin GroupExperimental Treatment1 Intervention
Subjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~250
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Interstitial Lung Disease (ILD) often target inflammation and oxidative stress, which are critical in disease progression. Glucocorticoids, such as prednisone, reduce inflammation by suppressing the immune response.
N-acetylcysteine (NAC) acts as an antioxidant, replenishing intracellular glutathione levels to combat oxidative damage in lung tissues. These mechanisms are crucial for ILD patients as they help to slow disease progression, improve lung function, and enhance quality of life.
The anti-inflammatory and antioxidant properties of treatments like Fisetin are particularly promising as they address these fundamental pathological processes.
Find a Location
Who is running the clinical trial?
Avni JoshiLead Sponsor
Avni Joshi, MD, MSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are in prison, living in an institution, or who may have difficulty making their own decisions, such as those with dementia.IgA levels are abnormal.I am currently in the hospital or might need to be hospitalized soon.I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.You currently smoke or use tobacco products.I was diagnosed with CVID at least 30 days ago according to international standards.I am a man who agrees to use contraception or abstain from sex with women who can become pregnant, from the start of the treatment until 48 hours after the last dose.You drink a lot of caffeine every day (400 mg or more).My doctor thinks I might have lung disease due to common variable immune deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Fisetin Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including: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.
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