Study on the Effectiveness and Safety of Iptacopan with Drug Combination for Adults with Active Lupus Nephritis Class III-IV, +/- V

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for lupus nephritis, a kidney condition that occurs in people with lupus. The study will explore the use of a medication called iptacopan, also known by its code name LNP023, in combination with standard treatments. These standard treatments include medications like mycophenolate mofetil or mycophenolate sodium, and corticosteroids such as prednisone. The trial will also involve a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The purpose of the study is to evaluate how effective and safe the treatment is for patients with active lupus nephritis, specifically those with Class III-IV, with or without Class V. Participants will receive different doses of iptacopan, either with or without corticosteroids, alongside their standard treatment. The study will last for up to 52 weeks, with the main focus on the first 24 weeks to see how many patients achieve a complete renal response, meaning their kidney function improves without any worsening of their condition.

Throughout the study, participants will be monitored for any changes in their condition and any side effects they may experience. The trial aims to provide valuable information on whether iptacopan can be a beneficial addition to the current treatment options for lupus nephritis. This research could potentially lead to better management of the disease and improved outcomes for patients in the future.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatment options being tested.

2 Initial treatment phase

The patient will begin treatment with one of the following regimens:

Iptacopan 200 mg taken twice daily (b.i.d) with a tapering dose of corticosteroids and either mycophenolate mofetil (MMF) or mycophenolate sodium (MPS).

Iptacopan 50 mg taken twice daily (b.i.d) with a tapering dose of corticosteroids and either MMF or MPS.

Iptacopan 200 mg taken twice daily (b.i.d) without a tapering dose of corticosteroids and either MMF or MPS.

The treatment will be compared to the standard of care, which includes a tapering dose of corticosteroids and either MMF or MPS.

3 Monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of kidney function and other health parameters.

The primary goal is to evaluate the proportion of patients achieving a complete renal response (CRR) at week 24, without any kidney flares.

4 Continuation of treatment

The patient will continue the assigned treatment regimen for the duration of the study, which is expected to last until 2028.

Regular follow-up visits will be scheduled to monitor the patient’s progress and adjust treatment as necessary.

5 Completion of the study

At the end of the study period, the patient’s overall health and treatment outcomes will be evaluated.

The study aims to determine the effectiveness and safety of the treatment regimens in managing lupus nephritis.

Who Can Join the Study?

Male and female patients who are 18 years of age or older at the time of screening.
Vaccination against Haemophilus influenzae infection should be given, if available and according to local regulations, at least 2 weeks before the first study drug is given. If the study treatment is expected to start earlier than 2 weeks after vaccination, preventive antibiotic treatment should be given at the start of the study treatment and continue for at least 2 weeks after vaccination.
Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required before the start of study treatment. If the patient has not been previously vaccinated, or if a booster is needed, the vaccine should be given according to local regulations at least 2 weeks before the first study drug is given. If the study treatment is expected to start earlier than 2 weeks after vaccination, preventive antibiotic treatment should be given for at least 2 weeks after vaccination.
All patients should have been on supportive care, including a stable dose of anti-malarials (like hydroxychloroquine), unless there is a reason not to use them.
Patients should be receiving a stable optimized ACE inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) therapy at either the locally approved maximum daily dose or the highest dose they can tolerate, as judged by the investigator, at randomization according to local clinical practice. The dose of ACEi/ARB therapy should remain stable throughout the study unless there is a clinically important reason to change it, such as the development of side effects or poorly controlled high blood pressure.
Patients with the first presentation or flare of lupus nephritis can be included. All participants with a lupus nephritis flare, following prior treatment with cyclophosphamide, can be included. Participants who have developed a lupus nephritis flare following treatment with mycophenolate mofetil (MMF) may be included if the treating physician believes that participation in the study could benefit the patient, considering the doses of MMF with or without corticosteroids being used in the study protocol.
All participants must be vaccinated for COVID-19 before randomization according to local standards of care. Participants should also have a negative COVID-19 test, performed according to local standards of care.
Participants must have a clearly positive anti-nucleosome antibodies (ANA) test result, defined as an ANA titre of 1:80 or higher, based on a specific test method, and/or a positive anti-double-stranded DNA (anti-dsDNA) test at screening.
Active biopsy-proven lupus nephritis within 3 months before screening, showing Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. If a biopsy was not performed within 3 months of screening, a repeat biopsy is needed to verify lupus nephritis as a main cause of flare. This kidney biopsy will need to be performed during the screening period and after confirmation that the patient has met all other inclusion/exclusion criteria at screening.
Documentation of active kidney disease at the time of screening that requires starting therapy with corticosteroids in combination with MMF/MPS. Active kidney disease will be defined by the following:
- Positive dipstick for hematuria (blood in urine) not related to menstruation or urinary tract infection (UTI).
- Proteinuria (protein in urine) to be confirmed at screening and before randomization. At screening: Urine Protein-To-Creatinine Ratio (UPCR) of 1.5 g/g or higher from a first morning urine sample or 24-hour urine collection. Before randomization: Confirmation of UPCR 1.5 g/g or higher from a 24-hour urine collection on two separate days, within a window of 10 days before randomization. The average of the UPCR values obtained from the two 24-hour urine collections will be used to confirm eligibility.
eGFR (estimated Glomerular Filtration Rate) of 30 ml/min/1.73 m² or higher, calculated using specific formulas according to ethnic groups and local practice guidelines. This measures how well the kidneys are working.

Who Cannot Join the Study?

Patients who have a different type of kidney disease than Lupus Nephritis Class III-IV, +/- V cannot participate. Lupus Nephritis is a kidney problem caused by lupus, an autoimmune disease where the body’s defense system attacks its own tissues.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent infection or illness that might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Clinico San Carlos	Madrid	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Hospital De Sagunto	Sagunto	Spain
University Of Debrecen	Debrecen	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Hopital Beaujon	Clichy	France
University Of Szeged	Szeged	Hungary
Ajhyekkkzo Pkghgywi Hkcdzsgb Db Mcvrlwixm	Marseille	France
Kcixsoab dca Ufhebcybnjtr Mxtrnfrz Ads	Munich	Germany
Hinzeqqm Ukqmymvxhpphgs Sixfyaqrls &dtiaqe Hxuqbsv du Hajpsdibdof	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	10.08.2022
Germany	Recruiting	10.08.2022
Hungary	Recruiting	10.08.2022
Portugal	Recruiting	10.08.2022
Spain	Recruiting	10.08.2022

Trial locations

Investigated drugs:

Iptacopan: This medication is being tested to see if it can help patients with active lupus nephritis, a kidney condition. It is being studied in combination with other treatments to see if it can improve kidney function without causing kidney flares. The trial is exploring different ways of using this medication, with or without corticosteroids, to find the best approach for patients.

Corticosteroids: These are commonly used medications that help reduce inflammation in the body. In this trial, they are used in combination with other treatments to manage lupus nephritis. The study is looking at how tapering off corticosteroids affects the treatment outcomes.

MMF/MPS: These are medications that help suppress the immune system. They are part of the standard treatment for lupus nephritis and are used in this trial to see how they work together with iptacopan and corticosteroids to improve kidney health in patients.

Investigated diseases:

Lupus nephritis

Lupus Nephritis – Lupus Nephritis is a kidney disorder that is a complication of systemic lupus erythematosus (SLE), an autoimmune disease. It occurs when the body’s immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. The disease is classified into different classes based on the severity and type of kidney involvement, with Class III and IV indicating more severe forms. Symptoms may include swelling, high blood pressure, and changes in urine, such as blood or protein. Over time, the inflammation can lead to scarring and loss of kidney function. The progression of the disease can vary, with periods of flare-ups and remission.

Trial ID:

2023-509332-26-00

Protocol code:

CLNP023K12201

NCT ID:

NCT05268289

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Iptacopan with Drug Combination for Adults with Active Lupus Nephritis Class III-IV, +/- V

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?