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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

18 Nov 2024 → ongoing

Decision date (initial)

2024-09-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2023-508996-35-00

ClinicalTrials.gov

NCT06293365

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Therapy, Efficacy, Safety, Pharmacodynamic

Cohort 1: To demonstrate the pharmacokinetic (PK) comparability of ianalumab 000 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Cohort 2: To demonstrate the pharmacokinetic (PK) comparability of ianalumab 000 mg s.c. at steady state between the 1 x 2 mL PFS and
2 x 1 mL PFS

Secondary objectives 3

1. Cohort 1: To evaluate the pharmacokinetics of ianalumab 000 mg s.c. at steady state under the 1 x 2mL AI and 2 x 1 mL PFS Cohort 2: To evaluate the pharmacokinetics of ianalumab 000 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS
2. To evaluate the safety and tolerability of ianalumab administered 000 mg s.c. monthly
3. To assess the immunogenicity of ianalumab administered 000 mg s.c. monthly

Conditions and MedDRA coding

Rheumatoid Arthritis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed informed consent must be obtained before any assessment is performed.
2. Male and female patients aged 18 years to 70 years (inclusive).
3. 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.
4. Diagnosed with RA, SjD and/or SLE as determined by the investigator.
5. Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
6. Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.
7. Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.

Exclusion criteria 7

1. Use of prohibited therapies.
2. Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
3. Plans for administration of live vaccines during the study period.
4. Uncontrolled co-existing serious disease.
5. Pregnant or nursing (lactating) women.
6. 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.
7. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 14

Locations

7 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 61 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications