Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

NCT05593588 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: 21-003119
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Interstitial Lung Disease Due to Systemic Disease; Common Variable Immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Change in immunophenotyping of peripheral T lymphocytes

  Measured by percentage of activated CD4+25+ T cells

  Baseline, 6 months

Secondary Outcomes (7)

• Change in Forced Vital Capacity (FVC)

  Baseline, 6 months

• Change in radiologic imaging in subjects

  Baseline, 3 months, 6 months

• Use of MRI imaging for assessment of GLILD

  6 months

• Infectious complications

  6 months

• Adverse Events

  6 months

Study Arms (2)

Fisetin Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Placebo DRUG

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

Placebo Group

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

Fisetin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Avni Joshi: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

fisetin

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Avni Joshi, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor and Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: April 12, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)