Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

NCT ID: NCT05593588

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Common Variable Immunodeficiency; Interstitial Lung Disease Due to Systemic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Fisetin

Intervention Type: 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 Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Fisetin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avni Joshi

OTHER

Sponsor Role: lead

Responsible Party

Avni Joshi

Regulatory Sponsor and Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Avni Joshi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

21-003119

Identifier Type: -

Identifier Source: org_study_id