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NCT06730126 · ClinicalTrials.gov registry record · Phase 2
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
A Phase 2 study of Autoimmune Lymphoproliferative Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 3
- Study locations
NCT06730126: Recruiting Phase 2 study of Autoimmune Lymphoproliferative Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06730126 is a Phase 2 study of Autoimmune Lymphoproliferative Syndrome that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06730126, a Phase 2 study of Autoimmune Lymphoproliferative Syndrome, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed. Objective: To test a study drug (soquelitinib) in people with ALPS. Eligibility: People aged 16 years and older with ALPS. Design: Participants will have 8 clinic visits and 6 remote visits within 1 year. Participants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function. Soquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form. Blood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body. Some participants may be able to remain in the study for a second year....
Primary Outcome
To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS.
Conditions Studied
Interventions
- DRUG Soquelitinib
Study Locations (3)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-03-10 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What NCT06730126 shows while recruiting
NCT06730126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Autoimmune Lymphoproliferative Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Soquelitinib is the first listed.
NCT06730126 reports a single indexed study location in Maryland, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT06730126 about?
NCT06730126 is a clinical study titled "Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients". Background: Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can hav...
What is the current status of trial NCT06730126?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2025-03-10. Estimated completion is 2026-12-01.
What conditions does trial NCT06730126 study?
This clinical trial studies the following conditions: Autoimmune Lymphoproliferative Syndrome.
What interventions are being tested in trial NCT06730126?
The interventions under investigation include: Soquelitinib (DRUG).
Who is sponsoring clinical trial NCT06730126?
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 NCT06730126 being conducted?
This trial has 3 study locations across Maryland, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06730126's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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