SenolyticsTreatment of Interstitial Lung Disease in Common Variable Immunodeficiency

Overview

About this study

The purpose of this study is to determine the effectiveness of Fisetin compared to placebo for treatment of subjects with granulomatous-lymphocytic interstitial lung disease (GLILD) in the context of Common Variable Immunodeficiency (CVID), as assessed quantitatively on radiologic imaging.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Eligibility last updated to match clinicaltrials.gov on 2/10/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Avni Joshi, M.D., M.S.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Dahir Sharif

(507) 255-1574

Sharif.Dahir@mayo.edu

More information

Publications

Publications are currently not available