Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

Avni Joshi

Status and phase: Invitation-only; Phase 2

Conditions: Common Variable Immunodeficiency; Interstitial Lung Disease Due to Systemic Disease

Treatments: Drug: Placebo; Drug: Fisetin

Study type: Interventional

Funder types: Other

Identifiers

NCT05593588

21-003119

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Fisetin Group

Experimental group

Description:

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)

Treatment:

Drug: Fisetin

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo