Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT05593588
• Date of registration: 21/10/2022
• Prospective Registration: Yes
• Primary sponsor: Avni Joshi
• Public title: Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency
• Scientific title: Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
• Date of first enrolment: April 12, 2023
• Target sample size: 20
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT05593588
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Avni Joshi, MD, MS
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Common Variable Immunodeficiency

Interstitial Lung Disease Due to Systemic Disease

Intervention(s)

Drug: Placebo

Drug: Fisetin

Primary Outcome(s)

Change in immunophenotyping of peripheral T lymphocytes [Time Frame: Baseline, 6 months]

Secondary Outcome(s)

Change in quality of life [Time Frame: Baseline, 6 months]

Change in Forced Vital Capacity (FVC) [Time Frame: Baseline, 6 months]

Infectious complications [Time Frame: 6 months]

Use of MRI imaging for assessment of GLILD [Time Frame: 6 months]

Change in 6 minute walk test [Time Frame: Baseline, 6 months]

Adverse Events [Time Frame: 6 months]

Change in radiologic imaging in subjects [Time Frame: Baseline, 3 months, 6 months]

Secondary ID(s)

21-003119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors