Trial · NCT06549114
Leniolisib for Immune Dysregulation in PIDs
NCT06549114, Phase 2, Completed, Pharming Technologies B.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leniolisib for Immune Dysregulation in PIDs. Trials, record NCT06549114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06549114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leniolisib for Immune Dysregulation in PIDs
- NCT number
- NCT06549114
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Pharming Technologies B.V.
- Conditions
- Primary Immunodeficiency Disorders (PIDs)
- Interventions
- Leniolisib
- First posted
- 2024-08-12
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs) , and Adverse Events (AEs) | From Baseline to the end of 20 weeks of Treatment | • To assess the number of AEs/SAEs and number of participants with AEs/SAEs |
| Secondary | To assess the PK of leniolisib in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • PK parameters for leniolisib defined by Cmax |
| Secondary | To assess the PK of leniolisib in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • PK parameters for leniolisib defined by Tmax |
| Secondary | To assess the PK of leniolisib in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • PK parameters for leniolisib defined by t1/2 |
| Secondary | To assess the PK of leniolisib in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • PK parameters for leniolisib defined by AUC (0-t) |
| Secondary | To assess the impact of leniolisib on lymphocyte PI3K/AKT/mTOR pathway activity in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • Percent change in pAKT and/or pS6 in B cells and/or T cells, under resting and stimulated conditions, at different dose levels of leniolisib relative to baseline pAKT/pS6 levels, as feasible |
| Secondary | To assess the impact of leniolisib on hemoglobin counts in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • Hemoglobin over time |
| Secondary | To assess the impact of leniolisib on platelet counts in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • Platelet count over time |
| Secondary | To assess the impact of leniolisib on absolute neutrophil counts in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • Absolute neutrophil count over time |
| Secondary | To assess the clinical efficacy of leniolisib on PID-related ILD in PID disorders linked to PI3K | From Baseline to the end of 20 weeks of Treatment | • Change in CT evidence of GLILD or other PID-related ILD evaluated using Hartmann scoring methodology |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes0
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 |
|---|---|
| 41608120 | DERIVED |
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/NCT06549114
GET https://conductscience.org/api/trials/v1/NCT06549114/registered?page=2