#1 Clinical Trials Search in Europe

Afimetoran Besilate Dihydrate

Afimetoran Besilate Dihydrate is a promising new drug being studied in clinical trials for the treatment of active Systemic Lupus Erythematosus (SLE). This article explores the ongoing research into its effectiveness and safety, providing insights into the potential benefits for patients with this challenging autoimmune condition.

Table of Contents

What is Afimetoran?

Afimetoran, also known by its scientific name Afimetoran Besilate Dihydrate or its sponsor product code BMS-986256, is a new medication being developed to treat Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease[1]. It comes in the form of a capsule that is taken orally (by mouth)[1].

What Condition Does Afimetoran Target?

Afimetoran is specifically designed to treat active Systemic Lupus Erythematosus (SLE). SLE is a complex autoimmune disease where the body’s immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body such as the skin, joints, kidneys, brain, and other organs[1].

How Does Afimetoran Work?

While the exact mechanism of action is not detailed in the provided information, Afimetoran is likely designed to modulate the immune system to reduce the excessive inflammation and tissue damage characteristic of SLE. As an investigational drug, its precise workings are still being studied in clinical trials[1].

Current Clinical Trial

Afimetoran is currently being evaluated in a Phase 2 clinical trial. This trial is designed to assess both the effectiveness and safety of Afimetoran compared to a placebo in patients with active SLE. Here are some key points about the trial:

  • It’s a multicenter study, meaning it’s conducted at multiple medical centers.
  • It’s randomized, which means participants are randomly assigned to either receive Afimetoran or a placebo.
  • It’s double-blind, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo during the study.
  • The main goal is to see if Afimetoran can improve lupus activity, primarily measured by a tool called the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).
  • The trial also aims to evaluate other aspects, such as organ-specific responses, the ability to reduce steroid use, and how the drug affects patients’ reported health status[1].

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some key inclusion criteria are:

  • Participants must have been diagnosed with SLE at least 12 weeks before the screening visit.
  • They must test positive for certain lupus-related autoantibodies.
  • They must have a certain level of disease activity as measured by the SLEDAI score.

Some exclusion criteria include:

  • Active severe lupus nephritis (kidney inflammation due to lupus)
  • Active or unstable neuropsychiatric lupus manifestations
  • Diagnosis of Mixed Connective Tissue Disease where SLE is not the predominant diagnosis
  • Antiphospholipid Syndrome (a disorder that can cause blood clots)[1]

How is the Effectiveness of Afimetoran Measured?

The effectiveness of Afimetoran is being evaluated using several measures:

  1. SLE Responder Index 4 (SRI[4]): This is the primary measure, looking at the proportion of participants who achieve a certain level of improvement at 48 weeks.
  2. British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA): This is another way to measure improvement in lupus activity.
  3. Lupus Low Disease Activity State (LLDAS): This measures how many participants achieve a state of low disease activity.
  4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI): This specifically looks at improvements in skin symptoms.
  5. Reduction in swollen and tender joints
  6. Changes in the Physician’s Global Assessment (PGA) score
  7. Ability to reduce corticosteroid use
  8. Changes in patient-reported quality of life using the SF-36 questionnaire[1]

Safety Considerations

As with any clinical trial, the safety of Afimetoran is being closely monitored. The researchers are tracking:

  • Serious Adverse Events (SAEs)
  • Adverse Events (AEs)
  • Changes in laboratory values (blood tests, urine tests, etc.)
  • Changes in physical examination findings
  • Changes in vital signs (temperature, blood pressure, heart rate, etc.)
  • Changes in electrocardiogram (ECG) parameters[1]

It’s important to note that as Afimetoran is still in the clinical trial phase, its full safety profile and effectiveness are not yet fully known. Patients interested in this treatment should discuss it with their healthcare provider and consider participating in clinical trials if appropriate.

Aspect Details
Drug Name Afimetoran Besilate Dihydrate
Trial Phase Phase 2
Condition Studied Active Systemic Lupus Erythematosus (SLE)
Main Objective Assess efficacy using SLEDAI-based composite measure
Key Secondary Objectives Evaluate BILAG-based response, organ-specific responses, steroid-sparing effect, patient-reported outcomes, safety and tolerability
Primary Endpoint SRI(4) response at Week 48
Key Inclusion Criteria SLE diagnosis ≥12 weeks, positive lupus autoantibodies, SLEDAI score ≥6
Key Exclusion Criteria Active severe lupus nephritis, unstable neuropsychiatric lupus
Treatment Duration 48 weeks with possibility of long-term extension

FAQ

  • What is the main purpose of the clinical trial for Afimetoran Besilate Dihydrate? The main purpose is to assess the effectiveness of Afimetoran compared to a placebo in improving lupus activity, primarily measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in patients with active SLE.
  • Who can participate in this clinical trial? Participants must have been diagnosed with SLE at least 12 weeks before screening, have a certain level of disease activity, and test positive for specific lupus-related autoantibodies. However, those with severe lupus nephritis or unstable neuropsychiatric lupus are not eligible.
  • How long does the main part of the trial last? The main part of the trial lasts for 48 weeks, with key assessments made at week 24 and week 48.
  • What are some of the key outcomes being measured in this trial? Key outcomes include the proportion of participants achieving specific improvements in disease activity, reductions in joint swelling and tenderness, improvements in skin symptoms, and the ability to reduce steroid use.
  • Is there an opportunity for participants to continue treatment after the main trial period? Yes, there is an optional long-term extension (LTE) period for participants who complete the 48-week treatment and, in the investigator's opinion, may benefit from continuing the treatment.

Ongoing Clinical Trials on Afimetoran Besilate Dihydrate

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

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Germany Ireland Poland Romania Spain

Glossary

  • Systemic Lupus Erythematosus (SLE): A chronic autoimmune disease that can affect various parts of the body, including skin, joints, kidneys, brain, and other organs.
  • SLEDAI: Systemic Lupus Erythematosus Disease Activity Index, a tool used to measure disease activity in lupus patients.
  • BILAG: British Isles Lupus Assessment Group, another system used to assess lupus disease activity.
  • SRI(4): SLE Responder Index 4, a composite measure used to evaluate improvement in lupus symptoms.
  • BICLA: BILAG-based Combined Lupus Assessment, a method to assess response to treatment in lupus patients.
  • LLDAS: Lupus Low Disease Activity State, a measure of reduced disease activity in lupus.
  • CLASI-A: Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, a tool to measure skin involvement in lupus.
  • Antinuclear antibody: An antibody that mistakenly targets substances within the cell nucleus, commonly found in lupus patients.
  • Anti-double-stranded DNA antibody: An antibody specific to lupus that attacks the genetic material in cells.
  • Anti-Smith antibody: Another antibody specific to lupus that targets certain proteins in the cell nucleus.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-afimetoran-for-patients-with-active-lupus/