Trial · NCT06897358
Leniolisib for Immune Dysregulation in CVID
NCT06897358, 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 CVID. Trials, record NCT06897358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06897358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leniolisib for Immune Dysregulation in CVID
- NCT number
- NCT06897358
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Pharming Technologies B.V.
- Conditions
- Common Variable Immunodeficiency (CVID)
- Interventions
- Leniolisib
- First posted
- 2025-03-26
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety & Tolerability | From baseline to the end of 24 weeks of treatment | To assess the number of AEs/SAEs and number of participants with AEs/SAEs |
| Secondary | Impact of leniolisib on lymphoproliferation measured as index lesions | From baseline to the end of 24 weeks of treatment | Percent change from baseline in lymphadenopathy measured as the sum of product of diameters (SPD) in the index lesions selected per the Cheson methodology |
| Secondary | Impact of leniolisib on lymphoproliferation measured as non-index lesions | From baseline to the end of 24 weeks of treatment | Percent change from baseline in lymphadenopathy measured as SPD of measurable non-index lesions selected as per the Cheson methodology |
| Secondary | Impact of leniolisib on spleen size | From baseline to the end of 24 weeks of treatment | Percent change from baseline in splenomegaly measured by three-dimensional (3D) volume and bi-dimensional (2D) size of spleen |
| Secondary | Impact of leniolisib on hemoglobin | From baseline to the end of 24 weeks of treatment | Hemoglobin will be evaluated over time |
| Secondary | Impact of leniolisib on platelets | From baseline to the end of 24 weeks of treatment | Platelet count will be evaluated over time |
| Secondary | Impact of leniolisib on neutrophils | From baseline to the end of 24 weeks of treatment | Absolute neutrophil counts will be evaluated over time |
| Secondary | Impact of leniolisib on GLILD or other PID-related ILD | From baseline to the end of 24 weeks of treatment | The change in CT evidence of GLILD or other PID-related ILD over time will be compared using the Hartmann Scoring Methodology |
| Secondary | Impact of leniolisib on pulmonary function in FEV1 | From baseline to the end of 24 weeks of treatment | Change in FEV1 will be evaluated |
| Secondary | Impact of leniolisib on pulmonary function in FVC | From baseline to the end of 24 weeks of treatment | Change in FVC will be evaluated |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06897358
GET https://conductscience.org/api/trials/v1/NCT06897358/registered