Senolytics Treatment of Interstitial Lung Disease in Comm... | NCT05593588

Studies
Senolytics Treatment of Interstitial Lung Disease in Common Variable Immunodeficiency

NCT05593588

Sponsor

Avni Joshi

Status

Active, not recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Common Variable Immunodeficiency
Interstitial Lung Disease Due to Systemic Disease

Interventions

Fisetin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Oct 21, 2022

First Submission Date that Met QC Criteria

Oct 21, 2022

First Posted Date

Oct 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jun 30, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fisetin Group	Experimental	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)	Drug: Fisetin
Placebo Group	Placebo Comparator	Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 & 1 and then repeated on days 28 & 29)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fisetin	Drug	20 mg per kilogram (kg) of body weight supplied in 100 mg capsules and administered orally on days 0, 1, 28, and 29	Fisetin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in immunophenotyping of peripheral T lymphocytes	Measured by percentage of activated CD4+25+ T cells	Baseline, 6 months

Secondary Outcomes

Measure	Description	Time Frame
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)	Baseline, 6 months
Change in radiologic imaging in subjects

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases