Clinical trial NCT05593588: Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency
Official title: Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Common Variable Immunodeficiency
Interstitial Lung Disease Due to Systemic Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in immunophenotyping of peripheral T lymphocytes
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Forced Vital Capacity (FVC)
timeFrame: Baseline, 6 months
measure: Change in radiologic imaging in subjects
timeFrame: Baseline, 3 months, 6 months
measure: Use of MRI imaging for assessment of GLILD
timeFrame: 6 months
measure: Infectious complications
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
measure: Change in quality of life
timeFrame: Baseline, 6 months
measure: Change in 6 minute walk test
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Avni Joshi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: