Trial · NCT06293365

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

NCT06293365, Phase 2, Active not recruiting, Novartis Pharmaceuticals

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease. Trials, record NCT06293365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06293365

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
NCT number: NCT06293365
Status: Active not recruiting
Phases: Phase 2
Enrollment: 155 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
Interventions: VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
First posted: 2024-03-05
Last updated: 2026-10-14

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT06293365

GET https://conductscience.org/api/trials/v1/NCT06293365/registered

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