Ianalumab for Autoimmune Diseases

Not currently recruiting at 47 trial locations

Overseen By Tamar Brionez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Infections, Live vaccines, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ianalumab, a treatment for autoimmune diseases such as rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus. Researchers aim to determine if different administration methods, like an auto-injector or a pre-filled syringe, have similar effects in the body. They also seek to confirm the treatment's safety and tolerability. Candidates for this trial have active symptoms of these conditions and may benefit from treatment targeting B-cells, a component of the immune system. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial requires that participants be on stable doses of their current medications for 4 weeks before starting the study treatment. This means you should not change your current medications before joining the trial.

What prior data suggests that these devices are safe for autoimmune disease patients?

Research has shown that ianalumab has been well-tolerated in past studies. For example, one study found that patients taking 300 mg doses did well for up to 52 weeks without major problems. This suggests that the treatment is generally safe for long-term use in humans. Additionally, data from other trials reported a favorable safety profile, indicating that most participants did not experience serious side effects. These findings are encouraging for anyone considering joining a trial involving ianalumab. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Ianalumab because it represents a novel approach to treating autoimmune diseases. Unlike many current treatments that broadly suppress the immune system, Ianalumab specifically targets and modulates certain immune cells, which may lead to fewer side effects and more effective disease management. This targeted action could offer a more precise treatment option, potentially improving patient outcomes by reducing disease activity while minimizing unwanted immune suppression.

What evidence suggests that ianalumab might be an effective treatment for autoimmune diseases?

Research has shown that ianalumab, the investigational treatment in this trial, may help treat autoimmune diseases such as Sjögren's disease. Studies have found that it can reduce disease activity and improve patient health, maintaining these improvements over time. Ianalumab targets overactive parts of the immune system in these conditions. Patients have generally tolerated it well, with no major increase in infections. These findings suggest that ianalumab could potentially help with conditions like rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus. ^{1 2 3 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition (RA, Sjögren's, or lupus) might improve with B-cell therapy.

I have signed the consent form for this trial.

My weight is between 35 kg and 150 kg, and my BMI is between 18 and 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment Period 1

Participants receive ianalumab 300 mg s.c. in one of two sequences, with a treatment switch at Week 12

12 weeks

Monthly visits

Treatment Period 2

Participants continue with the alternate treatment sequence of ianalumab 300 mg s.c.

12 weeks

Monthly visits

Extended Treatment Period

Participants have the option to continue receiving ianalumab 300 mg s.c. monthly

48 weeks

Monthly visits

Mandatory Post-Treatment Safety Follow-up

Participants are monitored for safety after the last study treatment

16 weeks

Conditional Post-Treatment Safety Follow-up

Participants are monitored until B-cell recovery or up to 2 years

up to 88 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ianalumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Cohort 2: Sequence 2 + Upper Arm Experimental Treatment 2 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 (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group II: Cohort 2: Sequence 2 + Thigh Experimental Treatment 2 Interventions

Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Thigh 2. x 1 mL) PFS in TP2 in Thigh (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group III: Cohort 2: Sequence 2 + Abdomen Experimental Treatment 2 Interventions

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen 1. X 2 mL) PFS in TP2 in Abdomen 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group IV: Cohort 2: Sequence 1 + Upper Arm Experimental Treatment 2 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 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group V: Cohort 2: Sequence 1 + Thigh Experimental Treatment 2 Interventions

Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh 1. X 2 mL) PFS in TP2 in Thigh 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group VI: Cohort 2: Sequence 1 + Abdomen Experimental Treatment 2 Interventions

Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm

Group VII: Cohort 1: Sequence 2 + Thigh Experimental Treatment 2 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 + Abdomen Experimental Treatment 2 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 + Thigh Experimental Treatment 2 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 + Abdomen Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Ianalumab, a new biologic treatment for primary Sjögren's syndrome, demonstrated a dose-related decrease in disease activity after 24 weeks, with the most significant improvement seen in the 300 mg dose group.

The treatment was generally well tolerated, with no increase in infections reported, indicating a favorable safety profile for patients with moderate to severe disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Bowman, SJ., Fox, R., Dörner, T., et al.[2022]

In a 5-year study of 70 patients with active rheumatoid arthritis, adalimumab (ADA) significantly improved disease activity, with a mean DAS28 score reduction from 6.5 to 3.6, indicating better control of symptoms.

The treatment also showed a favorable safety profile, with 60% of patients responding positively and 35.7% achieving remission, while only 14.28% experienced treatment failure requiring a switch to another biological agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab therapy in patients with active rheumatoid arthritis. Ancuţa, C., Ancuţa, E., Miu, S., et al.[2015]

The study evaluated two IgG subfractions from intravenous immunoglobulins (IVIg) and found that the anti-DNP fraction significantly protected against inflammation in models of autoimmune diseases, such as collagen-induced arthritis and experimental autoimmune encephalomyelitis in rats.

The anti-DNP fraction also reduced the incidence of spontaneous diabetes in nonobese diabetic mice at lower concentrations than standard IVIg, suggesting its potential for more effective treatment with fewer side effects by modulating proinflammatory cytokines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyreactive autoantibodies purified from human intravenous immunoglobulins prevent the development of experimental autoimmune diseases. Bruley-Rosset, M., Mouthon, L., Chanseaud, Y., et al.[2023]

In a 5-year study involving 2,228 patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, subcutaneous golimumab (GOL) demonstrated a safety profile consistent with previous findings, showing lower rates of serious infections compared to placebo.

However, higher doses of GOL (100 mg) were associated with increased incidences of tuberculosis, opportunistic infections, lymphoma, and demyelination compared to the lower dose (50 mg), suggesting careful monitoring is needed for patients on higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. Kay, J., Fleischmann, R., Keystone, E., et al.[2018]

In a study of 208 patients with active ankylosing spondylitis, intravenous golimumab (GOL) demonstrated significant efficacy, with 69.5% of patients achieving an ASAS20 response at 52 weeks, compared to 65.0% in the placebo crossover group.

The safety profile of GOL was consistent with previous findings, with 55.4% of patients experiencing at least one adverse event and only 3.4% reporting serious adverse events, indicating that GOL is a safe treatment option for active ankylosing spondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Intravenous Golimumab in Adults with Ankylosing Spondylitis: Results through 1 Year of the GO-ALIVE Study. Reveille, JD., Deodhar, A., Caldron, PH., et al.[2020]

In a study involving 10 patients with severe, treatment-resistant rheumatoid arthritis, high-dose intravenous immunoglobulin (IVIg) led to significant improvements in disease activity for all 9 patients who completed the treatment over 6 months.

The therapeutic effects of IVIg may be linked to its impact on specific immune cell ratios, particularly the CD4+CD45RA+ subset, although the benefits were temporary, with all patients experiencing a relapse after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose immunoglobulin therapy as an immunomodulatory treatment of rheumatoid arthritis. Tumiati, B., Casoli, P., Veneziani, M., et al.[2019]

Ianalumab (VAY736) demonstrated significant efficacy in reducing disease activity in patients with active primary Sjögren's syndrome, as shown by improvements in multiple clinical outcomes compared to placebo, including the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

The treatment resulted in rapid and sustained B cell depletion after a single infusion, with mild to moderate infusion reactions being the main side effects, indicating a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of primary Sjögren's syndrome with ianalumab (VAY736) targeting B cells by BAFF receptor blockade coupled with enhanced, antibody-dependent cellular cytotoxicity. Dörner, T., Posch, MG., Li, Y., et al.[2020]

Intravenous immunoglobulin (IVIG) is a widely used and relatively safe treatment for various conditions, including antibody deficiencies, autoimmune diseases, and certain infections, with established efficacy in clinical trials for disorders like idiopathic thrombocytopenic purpura and Guillain-Barré syndrome.

Despite its effectiveness, there is a lack of standardized therapeutic guidelines for IVIG use, including dosage and timing, highlighting the need for more multicentric controlled clinical trials to better document its benefits and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intravenously applied immunoglobulin in systemic, autoimmune and vasculitis diseases in children]. Zeman, K., Cywińska-Bernas, A.[2011]

In a study of 10 patients with severe pyoderma gangrenosum (PG), 7 patients experienced clearance of PG lesions after treatment with intravenous immunoglobulin (IVIG), suggesting its potential efficacy as an adjunct therapy.

While IVIG showed promise in treating PG, some patients reported side effects, including nausea and one case of aseptic meningitis, indicating that while generally acceptable, monitoring for adverse reactions is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pyoderma gangrenosum with intravenous immunoglobulin. Cummins, DL., Anhalt, GJ., Monahan, T., et al.[2008]

Immune checkpoints (ICPs) play a crucial role in maintaining immune tolerance, and their mechanisms have been validated as therapeutic targets for treating autoimmune diseases like multiple sclerosis and type-1 diabetes.

Recent clinical findings suggest that targeting ICPs can restore immune tolerance, with various therapeutic agents (such as antibodies and fusion proteins) showing promise, although safety considerations are essential for their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Checkpoints, a Novel Class of Therapeutic Targets for Autoimmune Diseases. Zhai, Y., Moosavi, R., Chen, M.[2022]

Citations

1.

novartis.com

novartis.com/news/media-releases/novartis-ianalumab-first-drug-reduce-disease-activity-and-patient-burden-sjogrens-disease-phase-iii-trials

Novartis ianalumab first drug to reduce disease activity and ...

Compared to placebo, ianalumab achieved a numerically greater reduction in disease activity by Week 16 with improvements sustained through Week ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05350072

Two-arm Study to Assess Efficacy and Safety of Ianalumab ...

Two-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome.

3.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/ianalumab-reduces-sjogren-disease-activity-in-late-stage-trials/

Ianalumab Reduces Sjögren Disease Activity in Late Stage ...

Findings showed both trials met the primary endpoint, demonstrating statistically significant improvement in Sjögren disease activity (as ...

4.

pmlive.com

pmlive.com/pharma_news/novartis-presents-new-positive-data-for-rheumatic-autoimmune-disease-treatment/

Novartis presents new positive data for rheumatic ...

The data demonstrated clinically meaningful improvements in patient outcomes, supporting ianalumab's potential as a first targeted therapy for ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34861168/

Safety and efficacy of subcutaneous ianalumab (VAY736) ...

Overall, ianalumab was well tolerated and safe, with no increase in infections. To our knowledge, this is the first large, randomised, ...

6.

ard.bmj.com

ard.bmj.com/content/80/Suppl_1/593

POS0692 IANALUMAB (VAY736) SAFETY AND ...

Ianalumab 300 mg was well tolerated up to 52 Wks. Exploratory efficacy showed that continuous dosing of 300 mg sc q4w provided sustained clinical benefit.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003496724510263

POS0692 IANALUMAB (VAY736) SAFETY AND ...

Ianalumab 300 mg was well tolerated up to 52 Wks. Exploratory efficacy showed that continuous dosing of 300 mg sc q4w provided sustained clinical benefit.