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NCT04097561 · ClinicalTrials.gov registry record · Phase 1
Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
A Phase 1 study of Idiopathic CD4 Lymphopenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04097561: Recruiting Phase 1 study of Idiopathic CD4 Lymphopenia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04097561 is a Phase 1 study of Idiopathic CD4 Lymphopenia that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04097561, a Phase 1 study of Idiopathic CD4 Lymphopenia, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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. Low levels of CD4 cells may make a person more likely to get sick. There are no approved treatments for ICL. Researchers think a drug called belimumab may be able to help in specific situations. Objective: To see if belimumab is safe for people with ICL. Eligibility: People ages 18-70 who have ICL and are participating in NIH protocol 09-I-0102 (EPIC) Design: Participants will be screened with: Medical and medication history Physical exam Questionnaire about mental health and depression Blood and urine tests Participants will have a baseline visit. This will include some repeats of the screening tests. They may also have leukapheresis: Blood will be taken from a needle in one arm and passed through a machine that separates out the white blood cells. The rest of the blood will be returned through a needle in the other arm. Participants will receive 8 doses of belimumab through IV: A needle will insert a thin plastic tube into an arm vein. Belimumab will be given through the IV line. The first 3 doses will be given every 2 weeks. The other 5 will be given once every 4 weeks. Participants will have a physical exam and blood and urine tests at each dosing visit. They will be monitored for up to 4 hours after the infusion. Participants will have 3 follow-up visits, at around 8, 16, and 24 weeks after the last dose of belimumab. They will have a physical exam and blood and urine tests. Once they finish this protocol and they will continue to be followed under 09-I-0102 (EPIC study).
Primary Outcome
Incidence of AEs that are possibly, probably, or definitely related to belimumab.
Conditions Studied
Interventions
- BIOLOGICAL Belimumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 1 |
What NCT04097561 shows while recruiting
NCT04097561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Idiopathic CD4 Lymphopenia appearing as the primary indexed condition, and to 1 intervention - of which Belimumab is the first listed.
NCT04097561 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04097561 about?
NCT04097561 is a clinical study titled "Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)". 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. Low levels of CD4 cells may make a person more likely to get sick. There are no approved treatments for ICL. Researchers think a dr...
What is the current status of trial NCT04097561?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-01-13. Estimated completion is 2026-03-25.
What conditions does trial NCT04097561 study?
This clinical trial studies the following conditions: Idiopathic CD4 Lymphopenia.
What interventions are being tested in trial NCT04097561?
The interventions under investigation include: Belimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04097561?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04097561 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic CD4 Lymphopenia
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Where NCT04097561's enrollment target sits among peer trials
20 1630th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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