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Tests treatment safety and results for Idiopathic CD4 Lymphopenia
Official title Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
ClinicalTrials.gov ID: NCT04097561
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for idiopathic cd4 lymphopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: People with Idiopathic CD4 lymphopenia (ICL) have lower numbers of a type of white blood cell called CD4 cells. White blood cells fight against infections.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 18-70 years.
- Enrolled in study 09-I-0102.
- Has a documented diagnosis of ICL, defined as the following:
- CD4 count \< 300 cells/microliter in at least 2 separate measurements 6 weeks apart at any point in the past, AND
You likely can't join if
- Individuals meeting any of the following criteria will be excluded from study participation:
- Prior receipt of belimumab. Exception: If an individual had been previously enrolled in this study and received up to 3 doses of belimumab but had to...
- Allergy to any component of belimumab formulation.
- HIV infection or other recognized congenital or acquired immunodeficiency.
- Current moderate or severe acute illness (eg, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) or...
- Untreated hepatitis B or C (acute or chronic).
See the full eligibility criteria
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 18-70 years.
- Enrolled in study 09-I-0102.
- Has a documented diagnosis of ICL, defined as the following:
- CD4 count \< 300 cells/microliter in at least 2 separate measurements 6 weeks apart at any point in the past, AND
- CD4 count \< 300 cells/microliter within previous 90 days.
- Evidence for autoantibody positivity (eg, ANA or in the research flow method looking for antilymphocyte antibodies).
- Female participants of childbearing potential must agree to use adequate contraception when engaging in sexual activities that can result in pregnancy, beginning at day 0 (or day 30 for hormonal contraception) until 4...
- Hormonal contraception.
- Male or female condom.
- Diaphragm or cervical cap with a spermicide.
- Intrauterine device.
- Able to provide informed consent.
- Willing to allow samples to be stored for future research.
- Individuals meeting any of the following criteria will be excluded from study participation:
- Prior receipt of belimumab. Exception: If an individual had been previously enrolled in this study and received up to 3 doses of belimumab but had to withdraw for reasons that were not related to safety or clinical...
- Allergy to any component of belimumab formulation.
- HIV infection or other recognized congenital or acquired immunodeficiency.
- Current moderate or severe acute illness (eg, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) or progressive serious infection related to ICL that, in the opinion of the...
- Untreated hepatitis B or C (acute or chronic).
- Active tuberculosis infection.
- Serum creatinine \> 1.5 times the upper limit of normal (ULN).
- Hemoglobin \< 8 g/dL.
- Alanine transaminase or aspartate transaminase \> 2 times ULN.
- Serum IgG \< 400 mg/L.
- Current use of systemic glucocorticosteroids, with the exception of corticosteroid nasal spray or inhaler and topical steroids.
- Any cancer diagnosis or autoimmune condition requiring systemic chemotherapy or immunomodulant-affecting antibody responses (eg, rituximab, ibrutinib), IV or SC Ig supplementation, radiation therapy, or any such...
- Severe depression. Psychiatry may be consulted prior to final eligibility decision.
- Infections (recently acquired or exacerbation of a chronic infection) that required new medications for management within the past 60 days.
- Receipt of any vaccination within the past 30 days.
- Pregnant.
- Breastfeeding.
- Any behavioral or substance use issue that would compromise appropriate follow up and participation in this study. Concomitant diagnosis of SLE will not be exclusionary. Although SLE can be associated with lymphopenia...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.