Trial · NCT05124925
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | Serum ianalumab concentrations PK parameters AUC calculated to the end of a dosing interval (tau) at steady state | 6 months treatment plus 2 years of follow-up | To assess the pharmacokinetics (PK) of ianalumab |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05124925/registered