Clinical Trials

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.