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Active, not recruitingNCT05593588Updated Jun 30, 2026

Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

A Phase 2 interventional study of Fisetin and Placebo in Common Variable Immunodeficiency and Interstitial Lung Disease Due to Systemic Disease, sponsored by Avni Joshi. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Avni Joshi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.

02

Conditions studied

  • Common Variable Immunodeficiency
  • Interstitial Lung Disease Due to Systemic Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient must have received a diagnosis of CVID according to the international consensus document (ICON) at least 30 days before enrollment.
  • Physician diagnosis of possible GLILD associated with CVID.
  • IgA results.
  • Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (A negative pregnancy test for women whose menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization).
  • Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial.
  • Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization.

WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.

  • 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.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Patient currently hospitalized or under immediate consideration for hospitalization.
  • Current use of tobacco products or as per clinical judgement.
  • Current excessive caffeine intake (400 mg or more per day).
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Fisetin Group

    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)

    Drug: Fisetin

  • Placebo comparator
    Placebo Group

    Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)

    Drug: Placebo

Interventions

  • DrugFisetin

    20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29

  • DrugPlacebo

    Looks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29

05

What researchers measure

Primary outcomes

  1. Change in immunophenotyping of peripheral T lymphocytes

    Measured by percentage of activated CD4+25+ T cells

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change in Forced Vital Capacity (FVC)

    Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)

    Time frame: Baseline, 6 months

  2. Change in radiologic imaging in subjects

    Number of subjects to have a 10% improvement with the CT scoring system. Radiologist will score the CT scans at each time point and changes in score at each time point will be noted.

    Time frame: Baseline, 3 months, 6 months

  3. Use of MRI imaging for assessment of GLILD

    Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use

    Time frame: 6 months

  4. Infectious complications

    Number of subjects to experience infectious complications

    Time frame: 6 months

  5. Adverse Events

    Number of adverse events reported

    Time frame: 6 months

  6. Change in quality of life

    Measured using the RAND 36-Short Form Survey Instrument (SF-36). The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability

    Time frame: Baseline, 6 months

  7. Change in 6 minute walk test

    Number of subjects to have a 10% improvement in 6 minute walk test. The 6 minute walk test measures the distance a person is able to walk in 6 minutes.

    Time frame: Baseline, 6 months

06

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05593588
Lead sponsor
Avni Joshi
Responsible party
Avni Joshi (Regulatory Sponsor and Principal Investigator, Mayo Clinic) — Sponsor-investigator
First posted
Oct 25, 2022
Start date
Apr 12, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 30, 2026

Study contacts

Avni Joshi, MD, MS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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