Trial · NCT05124925
Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.
NCT05124925, Phase 2, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments. Trials, record NCT05124925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05124925
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.
- NCT number
- NCT05124925
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Sjogren Syndrome
- Interventions
- Ianalumab
- First posted
- 2021-11-18
- Last updated
- 2026-02-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in logarithm of salivary gland B/B+T cell ratio | Week 25 | Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT) |
| Secondary | Number of participants with Adverse Events | 6 months treatment plus 2 years of follow-up | Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data. |
| Secondary | Change from baseline in disease activity at salivary gland level by ultrasound imaging | 6 months treatment plus 2 years of follow-up | Changes in salivary gland tissue (parenchymal abnormalities, vascularization, perfusion and stiffness) by multimodal salivary gland ultrasound (SGUS) after treatment with ianalumab |
| Secondary | Incidence of ADA positive patients | 6 months treatment plus 2 years of follow-up | Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive patients as a measure of immunogenicity (IG) of ianalumab |
| Secondary | Change of salivary flow | 6 months treatment plus 2 years of follow-up | Defined as change in stimulated and unstimulated salivary flow from baseline |
| Secondary | Serum ianalumab concentrations PK parameters Tmax | 6 months treatment plus 2 years of follow-up | To assess the pharmacokinetics (PK) of ianalumab |
| Secondary | Serum ianalumab concentrations AUCinf | 6 months treatment plus 2 years of follow-up | To assess pharmacokinetics (PK) of ianalumab |
| Secondary | Serum ianalumab concentrations C-max | 6 months treatment plus 2 years of follow-up | To assess pharmacokinetiks (PK) of ianalumab |
| Secondary | Serum ianalumab concentrations PK parameters AUC from dosing to the time of the last measurable concentrations (AUClast) | 6 months treatment plus 2 years of follow-up | To assess the pharmacokinetics (PK) of ianalumab |
| Secondary | Serum ianalumab concentrations PK parameters half life (T1/2) | 6 months treatment plus 2 years of follow-up | To assess the pharmacokinetics (PK) of ianalumab |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT05124925
GET https://conductscience.org/api/trials/v1/NCT05124925/registered