A randomized, two-period crossover study to demonstrate the comparability of pharmacokinetics of subcutaneous ianalumab between 2mL auto-injector/2mL pre-filled syringe with 1 mL pre-filled syringe in adult participants with autoimmune disease

Phase 2

Recruiting

• Conditions: Systemic Lupus erythematosus; Sjögren’s Disease; Rheumatoid Arthritis
• Interventions: Drug: -

• Registration Number: 2023-508996-35-00
• Lead Sponsor: Novartis Pharma AG

Brief Summary

Cohort 1: To demonstrate the pharmacokinetic (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS

Cohort 2 (optional): To demonstrate the pharmacokinetic (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and

2 x 1 mL PFS

Detailed Description

The study consists of the following periods:

Screening period (up to 4 weeks):

Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.

Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):

After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:

* Cohort 1:

* Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2

* Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2

* Cohort 2:

* Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2

* Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively.

Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 x 1 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72.

Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period.

Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to \>= 50 cells/μL or \>= 80% of baseline value, whichever occurs earlier.

Study Timeline

• Study First Posted: 2024-09-17
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

Signed informed consent must be obtained before any assessment is performed.

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.

Diagnosed with RA, SjD and/or SLE as determined by the investigator.

Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.

Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.

Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.

Exclusion Criteria

Use of prohibited therapies.

Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.

Plans for administration of live vaccines during the study period.

Uncontrolled co-existing serious disease.

Pregnant or nursing (lactating) women.

Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug.

US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
-	-	Participants receiving -

Primary Outcome Measures

Name	Time	Method
For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)		For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)

Secondary Outcome Measures

Name	Time	Method
For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough		For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough
Adverse events, laboratory evaluations, vital signs, ECG parameters		Adverse events, laboratory evaluations, vital signs, ECG parameters
Anti-ianalumab antibodies (ADA); incidence of ADA positive participants		Anti-ianalumab antibodies (ADA); incidence of ADA positive participants

Trial Locations

Locations (25)

Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Italy

Universita' Campus Bio-medico Di Roma; 🇮🇹 Rome, Italy

Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona; 🇮🇹 Salerno, Italy

Reumed Sp. z o.o.; 🇵🇱 Lublin, Poland

Malopolskie Badania Kliniczne Sp. z o.o.; 🇵🇱 Cracow, Poland

Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł Hrycaj; 🇵🇱 Poznań, Poland

Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Medical Plus s.r.o.; 🇨🇿 Uherske Hradiste, Czechia

Revmatologicky Ustav; 🇨🇿 Prague 2, Czechia

Revmatologie s.r.o.; 🇨🇿 Brno-Sever, Czechia

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Azienda Sanitaria Universitaria Friuli Centrale

🇮🇹Udine, Italy

Luca Quartuccio

Site contact

+390432559808

luca.quartuccio@asufc.sanita.fvg.it