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Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

Primary Purpose

Common Variable Immunodeficiency, Interstitial Lung Disease Due to Systemic Disease

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fisetin

Placebo

About this trial

This is an interventional treatment trial for Common Variable Immunodeficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fisetin Group

Placebo Group

Arm 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)

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

Outcomes

Primary Outcome Measures

Change in immunophenotyping of peripheral T lymphocytes

Measured by percentage of activated CD4+25+ T cells

Secondary Outcome Measures

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)

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.

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

Infectious complications

Number of subjects to experience infectious complications

Adverse Events

Number of adverse events reported

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

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.

Full Information

NCT ID

NCT05593588

First Posted

October 21, 2022

Last Updated

April 12, 2023

Sponsor

Avni Joshi

1. Study Identification

Unique Protocol Identification Number

NCT05593588

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 12, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Avni Joshi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Variable Immunodeficiency, Interstitial Lung Disease Due to Systemic Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fisetin Group

Arm Type

Experimental

Arm 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)

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fisetin

Intervention Description

20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Looks exactly like the study drug, but it contains no active ingredient. Administered orally on days 0, 1, 28 and 29

Primary Outcome Measure Information:

Title

Change in immunophenotyping of peripheral T lymphocytes

Description

Measured by percentage of activated CD4+25+ T cells

Time Frame

Baseline, 6 months

Secondary Outcome Measure Information:

Title

Change in Forced Vital Capacity (FVC)

Description

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)

Time Frame

Baseline, 6 months

Title

Change in radiologic imaging in subjects

Description

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.

Time Frame

Baseline, 3 months, 6 months

Title

Use of MRI imaging for assessment of GLILD

Description

Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use

Time Frame

6 months

Title

Infectious complications

Description

Number of subjects to experience infectious complications

Time Frame

6 months

Title

Adverse Events

Description

Number of adverse events reported

Time Frame

6 months

Title

Change in quality of life

Description

Time Frame

Baseline, 6 months

Title

Change in 6 minute walk test

Description

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.

Time Frame

Baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avni Joshi, MD, MS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

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