Trial · NCT06293365
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 | Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab | Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). | To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS |
| Primary | Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab | Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). | To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS |
| Primary | Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab | Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). | To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS. |
| Primary | Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab | Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24). | To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS. |
| Secondary | Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab | After the 3rd and 6th dose | To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS |
| Secondary | Cohort 2: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab | After the 3rd and 6th dose | To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS |
| Secondary | Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab | At the end of dosing interval | To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS |
| Secondary | Cohort 2: Concentration at the end of a dosing interval (Ctrough) for ianalumab | At the end of dosing interval | To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS |
| Secondary | Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months | To evaluate the safety and tolerability of ianalumab administered 300 mg s.c. monthly. |
| Secondary | Anti-ianalumab antibodies (ADA) | From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months | To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly |
| Secondary | Incidence of ADA positive participants | From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months | To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly |
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.
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