VAY736 + CFZ533 for Lupus

No longer recruiting at 41 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Corticosteroids, Antimalarials, Thalidomide, DMARDs

Must not be taking: Biologics, Calcineurin inhibitors, B-cell depleting

Disqualifiers: Thrombosis, HIV, Severe organ dysfunction, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two potential treatments, VAY736 and CFZ533, for individuals with systemic lupus erythematosus (SLE), a complex autoimmune condition where the immune system attacks the body. The researchers aim to assess the safety and effectiveness of these treatments in managing SLE symptoms. Participants will receive either the experimental drug or a placebo, alongside their usual care. This trial may suit someone diagnosed with SLE for at least six months who continues to experience significant symptoms despite standard treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should be on a stable dose of corticosteroids, anti-malarial, thalidomide, or another DMARD. It seems you may need to continue these medications as part of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CFZ533 (iscalimab) is generally safe for people. One study found it well tolerated, with no major safety issues, such as blood clots. Another study confirmed these results, showing CFZ533 is safe when used with standard lupus treatments.

For VAY736 (ianalumab), research suggests it is also well tolerated in lupus patients. Studies have demonstrated that using VAY736 for up to a year was manageable, with few side effects. Longer use even showed extra benefits in clinical and lab tests. These findings suggest that both CFZ533 and VAY736 are considered safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CFZ533 and VAY736 for lupus because these treatments offer new ways to manage this challenging condition. Unlike standard lupus treatments that often rely on corticosteroids and immunosuppressive drugs, CFZ533 targets the CD40 receptor, playing a crucial role in immune response modulation. VAY736 works by targeting the BAFF receptor, which is involved in the survival of B cells that can contribute to lupus symptoms. These novel mechanisms of action provide a fresh approach, potentially reducing the disease's impact more effectively and with fewer side effects.

What evidence suggests that this trial's treatments could be effective for lupus?

Research has shown that CFZ533 (iscalimab), one of the treatments studied in this trial, might help treat systemic lupus erythematosus (SLE). In earlier studies, adding CFZ533 to standard treatments helped manage symptoms and was generally safe and well-tolerated.

VAY736 (ianalumab), another treatment option in this trial, also shows promise for SLE treatment. Research suggests that VAY736 effectively reduced B cells, which are involved in the disease, and improved patient outcomes. Long-term use of VAY736 was linked to additional benefits and was well-tolerated. Both treatments in this trial offer hope for relieving SLE symptoms. ^{1 2 4 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 SLE patients with certain autoantibodies, meeting at least 4 of the ACR's criteria, diagnosed for 6+ months, on stable meds, and have active disease. Excluded are those with recent potent treatments or B-cell depleting therapies, infections like HIV/TB/Hepatitis, severe diseases or organ dysfunction.

Inclusion Criteria

I have been diagnosed with lupus for at least 6 months.

My blood test shows high levels of antibodies linked to lupus.

SLEDAI-2K score of ≥6 at screening

Exclusion Criteria

I do not have active hepatitis B or C.

I am at high risk for blood clots due to my medical history or conditions.

Evidence of past exposure to tuberculosis as assessed by Quantiferon testing at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Blinded Treatment

Participants receive either VAY736 or CFZ533 or placebo in a blinded manner

28 weeks

Every 4 weeks (in-person)

Open-label Treatment

Participants in the active treatment group continue with active treatment, and those in the placebo group start active treatment

20 weeks

Every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Scheduled as deemed appropriate

Secondary Follow-up (Cohort 1)

Participants who do not achieve B-cell recovery by Week 69 enter a secondary follow-up period until achieving B-cell recovery criteria

Variable until B-cell recovery

What Are the Treatments Tested in This Trial?

Interventions

• CFZ533
• VAY736

Trial Overview The study tests VAY736 and CFZ533 against placebos to assess their safety and effectiveness in treating SLE. It involves monitoring how the body processes these drugs and their impact on disease symptoms over time.

How Is the Trial Designed?

Group I: Cohort 2 CFZ533 Experimental Treatment 1 Intervention

Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.

Group II: Cohort 1 VAY736 Experimental Treatment 1 Intervention

Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

Group III: Cohort 2 CFZ533 Placebo Placebo Group 2 Interventions

Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.

Group IV: Cohort 1 VAY736 Placebo Placebo Group 2 Interventions

Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40813108/

a randomised, double-blind, placebo-controlled, phase II ... Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo- ...

2. rmdopen.bmj.com rmdopen.bmj.com/content/11/3/e005557

Efficacy, pharmacokinetics and safety of iscalimab ... This study evaluated the efficacy, pharmacokinetics and safety of iscalimab versus placebo as add-on to standard-of-care (SoC) therapy in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03656562

NCT03656562 | Study the Efficacy and Safety of VAY736 ... This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 ...

4. ctv.veeva.com ctv.veeva.com/study/study-the-efficacy-and-safety-of-vay736-and-cfz533-in-sle-patients

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE ... This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03610516

Study Details | NCT03610516 | Safety, Pharmacokinetics ... This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03656562

NCT03656562 | Study the Efficacy and Safety of VAY736 ... This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522221996

First-in-human clinical trial to assess pharmacokinetics, ... All doses were generally safe and well tolerated, with no clinically relevant changes in any safety parameters, including no evidence of thromboembolic events.