Iptacopan for Lupus Nephritis

Recruiting at 114 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called iptacopan for individuals with lupus nephritis, a kidney condition caused by lupus. Researchers aim to determine the effectiveness and safety of iptacopan when combined with standard treatments. The trial includes different groups, with some receiving iptacopan and others a placebo (a substance with no active medication) alongside their regular care. Suitable candidates are those with lupus nephritis requiring treatment with corticosteroids and mycophenolate mofetil (MMF) or mycophenolic acid (MPS). As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that iptacopan has been tested for safety in humans. In earlier studies, most patients tolerated iptacopan well. Some mild side effects occurred, but they were manageable. It is important to know that this treatment remains under investigation. While some safety information is available, more is needed to fully understand its safety. Prospective trial participants should discuss any concerns with the trial team or their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus nephritis?

Unlike the standard treatments for lupus nephritis, such as corticosteroids and immunosuppressants, Iptacopan works uniquely by targeting the alternative complement pathway. This pathway plays a significant role in the inflammation and kidney damage seen in lupus nephritis. By specifically inhibiting this pathway, Iptacopan has the potential to offer more precise control of the disease with potentially fewer side effects. Researchers are excited about this approach because it addresses the underlying disease mechanisms directly, which could lead to more effective and safer treatments for patients.

What evidence suggests that iptacopan could be an effective treatment for lupus nephritis?

Research has shown that iptacopan, also known as Fabhalta, may help treat lupus nephritis by blocking a part of the immune system called the complement system, which reduces inflammation and kidney damage. Previous studies found that iptacopan significantly reduced protein in the urine, a key sign of kidney damage, with positive effects observed within just two weeks of treatment. In this trial, some participants will receive iptacopan alongside standard care, while others will receive a placebo matching iptacopan with standard care. This suggests that iptacopan could improve kidney health for people with lupus nephritis. ^{1 3 4 5 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05268289

NCT05268289 | Study of Efficacy and Safety of LNP023 in ... The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

2. novartis.com novartis.com/clinicaltrials/study/nct05268289

Study of Efficacy and Safety of LNP023 in Participants With ... The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

3. kireports.org kireports.org/article/S2468-0249(23)00197-3/fulltext

WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION ... This study aims to evaluate the efficacy and safety of iptacopan (an oral proximal complement inhibitor that specifically binds to factor B and inhibits the AP)

4. novartis.com novartis.com/us-en/news/media-releases/novartis-oral-fabhalta-iptacopan-sustained-clinically-meaningful-results-one-year-phase-iii-c3-glomerulopathy-c3g-trial

Novartis oral Fabhalta® (iptacopan) sustained clinically ... These data confirm treatment with Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468024923001973

WCN23-0405 AN ADAPTIVE, DOSE-EXPLORATION ... This adaptive proof-of-concept and dose-exploration Phase 2 study is designed to ascertain whether iptacopan can improve outcomes in patients with LN while also ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05268289?term=AREA%5BBasicSearch%5D(CLNP023K12201)&rank=1

Study of Efficacy and Safety of LNP023 in Participants With ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...