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107 Participants Needed

VAY736 + CFZ533 for Lupus

Recruiting at 31 trial locations

Overseen ByNovartis 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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.

How does the drug VAY736 + CFZ533 differ from other lupus treatments?

The combination of VAY736 and CFZ533 for lupus is unique because it targets specific immune pathways, potentially offering a novel approach compared to traditional treatments that often focus on broad immunosuppression. This combination may provide a more targeted therapy, which could lead to fewer side effects and improved outcomes for patients with lupus.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

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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

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Timeline

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

Treatment Details

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.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2 CFZ533Experimental Treatment1 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 VAY736Experimental Treatment1 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 PlaceboPlacebo Group2 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 PlaceboPlacebo Group2 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.