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Monoclonal Antibodies

Ianalumab for Autoimmune Diseases

Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients aged 18 years to 70 years (inclusive).
Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of dosing interval
Awards & highlights

Summary

This trial aims to compare the levels of ianalumab in the body after receiving one injection using an auto-injector versus two injections using pre-filled syringes. The study will also assess

Who is the study for?
This trial is for adults aged 18-70 with autoimmune diseases like RA, Sjögren's disease, or lupus. Participants must weigh between 35-150 kg with a BMI of 18-35 and have active disease that could benefit from B-cell depletion therapy. They should be on stable doses of standard treatments for at least four weeks before the study starts.
What is being tested?
The study tests if ianalumab given by a new auto-injector (300 mg/2 mL) is comparable to the current method using pre-filled syringes (two injections of 150 mg/1 mL). It also assesses safety and tolerability in patients with rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus.
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include irritation at injection site, potential allergic reactions to medication components, general discomforts such as headaches or nausea related to immune system modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My weight is between 35 kg and 150 kg, and my BMI is between 18 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over a dosing interval after 3rd (between week 8 and 12) and 6th dose (between week 20 and 24).
This trial's timeline: 3 weeks for screening, Varies for treatment, and over a dosing interval after 3rd (between week 8 and 12) and 6th dose (between week 20 and 24). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
+1 more
Secondary outcome measures
Anti-ianalumab antibodies (ADA)
Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab
Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
+4 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort 2: Sequence 2 + Upper ArmExperimental Treatment2 Interventions
Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Upper Arm 2. x 1 mL) PFS in TP2 in Upper Arm (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group II: Cohort 2: Sequence 2 + ThighExperimental Treatment2 Interventions
Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Thigh 2. x 1 mL) PFS in TP2 in Thigh (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group III: Cohort 2: Sequence 2 + AbdomenExperimental Treatment2 Interventions
Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen (1 X 2 mL) PFS in TP2 in Abdomen (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group IV: Cohort 2: Sequence 1 + Upper ArmExperimental Treatment2 Interventions
Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm (1 X 2 mL) PFS in TP2 in Upper Arm (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group V: Cohort 2: Sequence 1 + ThighExperimental Treatment2 Interventions
Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) PFS in TP2 in Thigh (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group VI: Cohort 2: Sequence 1 + AbdomenExperimental Treatment2 Interventions
Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm
Group VII: Cohort 1: Sequence 2 + ThighExperimental Treatment2 Interventions
Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen
Group VIII: Cohort 1: Sequence 2 + AbdomenExperimental Treatment2 Interventions
Patients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen
Group IX: Cohort 1: Sequence 1 + ThighExperimental Treatment2 Interventions
Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen
Group X: Cohort 1: Sequence 1 + AbdomenExperimental Treatment2 Interventions
Patients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,864 Total Patients Enrolled
~93 spots leftby Jul 2025
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