Iptacopan for Lupus Nephritis

Recruiting at 98 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Corticosteroids, MMF/MPS, Antimalarials

Must not be taking: Cyclophosphamide, Calcineurin inhibitors

Disqualifiers: RPGN, IF/TA, Glomerulosclerosis, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called iptacopan to see if it can help patients when added to their usual treatments. It targets patients who are already receiving standard care and aims to make their current treatments work better.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that you should continue a stable dose of anti-malarials, ACE inhibitors, or ARBs if you are already on them. It's best to discuss your specific medications with the trial team.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for people who are experiencing their first or a recurring episode of lupus nephritis, specifically class III or IV. Participants must have active kidney disease and be vaccinated against certain infections. Those who've had recent kidney treatments or biopsies, or specific medications like cyclophosphamide, cannot join.

Inclusion Criteria

My kidney problems are due to a first-time or worsening lupus.

I have been diagnosed with severe lupus affecting my kidneys.

I have been vaccinated against meningitis and pneumonia.

Exclusion Criteria

I have had a kidney biopsy in the last 3 months or am willing to get one.

I have recently been treated with cyclophosphamide or drugs that suppress my immune system.

There may be additional criteria that apply to this study which will be explained in detail.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive iptacopan or placebo in combination with standard of care

24 weeks

Regular visits for monitoring and assessment

Treatment Part 2

Continuation of treatment with iptacopan or placebo in combination with standard of care

28 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Iptacopan

Trial Overview The study tests the effectiveness and safety of iptacopan (LNP023) in treating lupus nephritis when added to standard care. It's divided into two parts: one where participants get iptacopan plus placebo, and another with just iptacopan.

Participant Groups

Group I: Placebo matching iptacopan + standard of care (part 2) Active Control 1 Intervention

Placebo matching iptacopan + standard of care

Group II: Iptacopan + standard of care (part 2) Active Control 1 Intervention

Iptacopan + standard of care

Group III: Iptacopan + placebo (part 2) Active Control 1 Intervention

Iptacopan + placebo standard of care

Group IV: Iptacopan + standard of care (part 1) Active Control 1 Intervention

Iptacopan + standard of care

Group V: Placebo matching iptacopan + standard of care (part 1) Placebo Group 1 Intervention

Placebo matching iptacopan standard of care

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