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OpenTrials
Active, Not Recruiting

NCT Number: NCT05593588

Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Fisetin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in immunophenotyping of peripheral T lymphocytes

    Time frame: Baseline, 6 months

    Measured by percentage of activated CD4+25+ T cells

Secondary outcomes

  1. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline, 6 months

    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)

  2. Change in radiologic imaging in subjects

    Time frame: Baseline, 3 months, 6 months

    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.

  3. Use of MRI imaging for assessment of GLILD

    Time frame: 6 months

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

  4. Infectious complications

    Time frame: 6 months

    Number of subjects to experience infectious complications

  5. Adverse Events

    Time frame: 6 months

    Number of adverse events reported

  6. Change in quality of life

    Time frame: Baseline, 6 months

    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

  7. Change in 6 minute walk test

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

Avni Joshi

Other

Registry information

Official study title

Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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