Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

Common Variable Immunodeficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05593588
• Other study ID #: 21-003119
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: April 12, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Common Variable Immunodeficiency
• Immunologic Deficiency Syndromes
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Fisetin
20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29
• Placebo
Looks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Avni Joshi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in immunophenotyping of peripheral T lymphocytes	Measured by percentage of activated CD4+25+ T cells	Baseline, 6 months
Secondary	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)	Baseline, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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	6 months
Secondary	Infectious complications	Number of subjects to experience infectious complications	6 months
Secondary	Adverse Events	Number of adverse events reported	6 months
Secondary	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	Baseline, 6 months
Secondary	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.	Baseline, 6 months