Trial · NCT06730126
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
NCT06730126, Phase 2, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients. Trials, record NCT06730126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06730126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
- NCT number
- NCT06730126
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Autoimmune Lymphoproliferative Syndrome
- Interventions
- Soquelitinib
- First posted
- 2024-12-12
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan. | Day 90 | To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS. |
| Secondary | Shrinkage in spleen volume from baseline to day 90. | Day 90 | To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS. |
| Secondary | Shrinkage in target lymph node volume from baseline to day 90. | Day 90 | To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS. |
| Secondary | Reduction of cytopenias by one severity level from baseline to day 90 | Day 90 | To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS and to determine the safety and tolerability of soquelitinib in people with ALPS-FAS. |
| Secondary | Reduction in prednisone dosage. | End of Study | To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS |
| Secondary | Grade 3 or 4 systemic infections within 360 days. | Day 360 | To determine the safety and tolerability of soquelitinib in people with ALPS-FAS. |
| Secondary | Clinically significant worsening of viral, mycobacterial, or fungal infection requiring new treatment or change of treatment by day 360. | End of Study | To determine the safety and tolerability of soquelitinib in people with ALPS-FAS. |
| Secondary | Any drug-related grade 3 or 4 AE AE that triggers a pause. | End of Study | To determine the safety and tolerability of soquelitinib in people with ALPS-FAS. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24398331 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06730126
GET https://conductscience.org/api/trials/v1/NCT06730126/registered