Study on the Effectiveness and Safety of Afimetoran for Patients with Active Lupus

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Afimetoran in individuals with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The trial aims to evaluate how effective and safe Afimetoran is compared to a placebo in managing the symptoms of active SLE.

Participants in the study will receive either Afimetoran or a placebo in the form of capsules taken orally. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure unbiased results. The trial will last for a period of time, during which participants will be monitored for changes in their condition and any side effects they may experience.

The main goal of the study is to see if Afimetoran can improve the activity of lupus, as measured by a specific index called the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Participants will be assessed at various points throughout the study to determine the medication’s impact on their lupus symptoms and overall health. The study will also track any adverse events or changes in laboratory values to ensure the safety of the participants.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of systemic lupus erythematosus (SLE) made at least 12 weeks prior and testing for specific lupus-related antibodies.

A score on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is required, with a total score of 6 or more and a clinical score of 4 or more, indicating joint involvement or rash.

2 randomization and treatment allocation

Participants are randomly assigned to receive either Afimetoran or a placebo. The treatment is administered orally in the form of a capsule.

The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

3 treatment phase

Participants take the assigned capsule daily for a period of 48 weeks. The dosage and specific instructions are provided by the study team.

Regular monitoring is conducted to assess the efficacy and safety of the treatment, focusing on improvements in lupus activity and any side effects.

4 evaluation at week 24

At week 24, an evaluation is performed to measure the response to treatment. This includes assessing the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) and the SLE Responder Index 4 (SRI[4]).

Additional assessments include changes in joint counts, skin condition, and overall disease activity.

5 evaluation at week 48

At week 48, a final evaluation is conducted to determine the proportion of participants achieving a significant response, as defined by the SLE Responder Index 4 (SRI[4]).

Further assessments include changes in disease activity, joint counts, and any adverse events experienced during the trial.

6 long-term extension option

Participants who complete the 48-week treatment phase may be eligible for a long-term extension period if deemed beneficial by the investigator.

This optional phase allows for continued monitoring and treatment beyond the initial study period.

Who Can Join the Study?

You must have been diagnosed with Systemic Lupus Erythematosus (SLE) at least 12 weeks before the screening visit. SLE is a condition where the immune system attacks the body’s own tissues.
You need to test positive for at least one of the following lupus-related autoantibodies:
- Antinuclear antibody at a level of 1:80 or higher. This is a type of protein made by the immune system that can attack the body’s own cells.
- Anti-double-stranded deoxyribonucleic acid (dsDNA) antibody. This is another type of protein that targets the DNA inside cells.
- Anti-Smith antibody. This is a protein that targets specific parts of the cell’s nucleus.
You should have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of 6 points or more, and a clinical Hybrid SLEDAI score of 4 points or more, with joint involvement and/or rash. This score measures the activity or severity of lupus symptoms.
If you are participating in the long-term extension (LTE) period, you must have completed the study treatment through Week 48, and the investigator should believe that you may benefit from continuing in the optional LTE period.
Both female and male participants are eligible to join the study.
The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who Cannot Join the Study?

Having any other serious health condition that could interfere with the study.
Being pregnant or breastfeeding.
Having a history of severe allergic reactions to similar medications.
Using certain medications that might interfere with the study treatment.
Having a recent history of drug or alcohol abuse.
Having an active infection that requires treatment.
Having received a live vaccine within a certain period before the study.
Having a history of cancer, except for certain types that have been treated and are not active.
Having a history of certain blood disorders.
Having a history of certain heart conditions.
Having a history of certain liver conditions.
Having a history of certain kidney conditions.
Having a history of certain lung conditions.
Having a history of certain neurological conditions.
Having a history of certain psychiatric conditions.
Having participated in another clinical trial recently.
Having a history of non-compliance with medical treatments.
Having any condition that, in the opinion of the study doctor, makes participation unsafe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Hospital Universitario Virgen De Valme	Sevilla	Spain
Hightech Medical Services S.R.L.	Bucharest	Romania
Medyczne Centrum Hetmanska	Poznan	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hopital Europeen Marseille	Marseille	France
Saint Maria Hospital	Bucharest	Romania
Charite Research Organisation GmbH	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Our Ladys Hospital Manorhamilton	Sligo	Ireland
Connolly Hospital	Dublin	Ireland
Hopital Huriez	Lille	France
MICS Centrum Medyczne Warszawa	Warsaw	Poland
Sl Mktcvyqyccyizvd Sfm	Ramnicu Valcea	Romania
Ceuhdun dz Kdbixofanpprs sx Mpvqq Bliwi Slg	Timisoara	Romania
Ukjxasebjktexbiabsqhe Erveh Amt	Essen	Germany
Hnpqbhvq Utyexqltchoch Mlrrjxi Dp Vmuiftizuz	Santander	Spain
Hbofdiev Veme dcpfzevg	Barcelona	Spain
Hdmfeeqt Uuojgkiwybwjj db A Cnabvp	A Coruna Galicia	Spain
Htrrkbwa Uadxffygwocgqe Siddedygfu &xpqbjk Hkzdhob di Hapbkyikqyz	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	23.08.2021
Germany	Not recruiting	23.08.2021
Ireland	Not recruiting	23.08.2021
Poland	Not recruiting	23.08.2021
Romania	Not recruiting	23.08.2021
Spain	Not recruiting	23.08.2021

Trial locations

Investigated drugs:

Afimetoran Besilate Dihydrate

Afimetoran is a medication being studied for its potential to help people with active Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body’s own tissues. The trial aims to see if Afimetoran can reduce the symptoms and activity of lupus, making it easier for patients to manage their condition.

Investigated diseases:

Systemic lupus erythematosus

Active Systemic Lupus Erythematosus – This is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissues, leading to inflammation and damage in various parts of the body. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever. The disease can have periods of flares, where symptoms worsen, and remissions, where symptoms improve. The progression of the disease varies greatly among individuals, with some experiencing mild symptoms and others having more severe complications. Managing the disease often involves monitoring and addressing the symptoms as they arise.

Trial ID:

2023-504320-25-00

Protocol code:

IM026-024

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Afimetoran for Patients with Active Lupus

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