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Clofutriben

A new clinical trial is investigating the use of Clofutriben (SPI-62) in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR). This Phase II study aims to determine the optimal dosing of both medications to provide effective treatment while potentially reducing the side effects associated with prednisolone use. The trial involves multiple cohorts testing different dosage combinations to find the best balance between efficacy and safety for PMR patients.

Table of Contents

What is CLOFUTRIBEN?

CLOFUTRIBEN, also known as SPI-62 or ASP3662, is a new medication being studied for the treatment of polymyalgia rheumatica (PMR). It is currently in Phase II clinical trials, which means it is being tested to determine its effectiveness and safety in patients with PMR.[1]

CLOFUTRIBEN comes in the form of a film-coated tablet that is taken orally (by mouth). The medication is being developed by Sparrow Pharmaceuticals, Inc.[1]

What is Polymyalgia Rheumatica (PMR)?

Polymyalgia rheumatica (PMR) is a medical condition that causes muscle pain and stiffness, usually in the shoulders, upper arms, and hips. It primarily affects older adults and is often treated with corticosteroids like prednisolone. PMR can significantly impact a person’s quality of life, making everyday activities difficult.[1]

How CLOFUTRIBEN Works

While the exact mechanism of action is not fully described in the provided information, CLOFUTRIBEN is being studied in combination with prednisolone, a commonly used corticosteroid for PMR treatment. The main objectives of the study are:

  1. To determine if the prednisolone dose needs to be adjusted when given with CLOFUTRIBEN to maintain its effectiveness in treating PMR.[1]
  2. To observe if CLOFUTRIBEN can reduce the side effects (toxicity) of prednisolone in PMR patients.[1]
  3. To understand how CLOFUTRIBEN works in the body of PMR patients.[1]
  4. To assess the safety of CLOFUTRIBEN when used alongside prednisolone in PMR treatment.[1]

Clinical Trial Details

The clinical trial for CLOFUTRIBEN is designed to test different combinations of the drug with prednisolone. Here’s a simplified breakdown of the trial structure:

  • The trial is divided into different groups (cohorts) of patients.
  • All patients start on a stable dose of 10 mg prednisolone daily.
  • Different cohorts receive varying doses of CLOFUTRIBEN (ranging from 0.6 mg to 6 mg daily) and prednisolone (10 mg to 30 mg daily).
  • The treatment period lasts for 28 days, with patients receiving CLOFUTRIBEN for two weeks and a placebo (a pill with no active ingredient) for two weeks.
  • Patients don’t know when they’re receiving CLOFUTRIBEN or the placebo, which helps ensure unbiased results.
  • After the treatment period, there’s a follow-up visit about a month later.[1]

Eligibility Criteria

To participate in the CLOFUTRIBEN clinical trial, patients must meet certain criteria. Here are some key points:

Inclusion criteria (requirements to join the study):

  • Diagnosed with PMR according to specific medical criteria
  • No current PMR relapse (worsening of symptoms)
  • Taking a stable dose of 10 mg prednisolone daily for at least a week before starting the trial[1]

Exclusion criteria (reasons a person cannot join the study):

  • Any reason why they can’t take prednisolone
  • Diagnosis or symptoms of giant cell arteritis (a related inflammatory condition)
  • Other autoimmune diseases besides PMR
  • Use of certain other medications that might interfere with the study
  • History of a condition called endogenous hypercortisolism (where the body produces too much cortisol)[1]

Potential Benefits of CLOFUTRIBEN

While the full benefits of CLOFUTRIBEN are still being studied, the researchers hope to find that it can:

  • Improve the effectiveness of prednisolone in treating PMR symptoms
  • Reduce the side effects associated with prednisolone use
  • Potentially allow for lower doses of prednisolone while maintaining symptom control[1]

Safety Considerations

As with any new medication, the safety of CLOFUTRIBEN is a crucial aspect of the clinical trial. The researchers will be closely monitoring participants for any side effects or adverse reactions. Some key points about safety:

  • The trial includes a placebo period to help distinguish between effects of CLOFUTRIBEN and those of prednisolone alone.
  • Participants will have regular check-ups and tests to monitor their health throughout the trial.
  • The researchers will be looking at various health markers, including blood tests for inflammation levels and tests to check how the body is processing sugars.[1]

It’s important to note that as CLOFUTRIBEN is still in the testing phase, not all potential side effects or long-term impacts are known. This is why careful monitoring and follow-up are crucial parts of the clinical trial process.

Aspect Details
Study Type Phase II therapeutic exploratory clinical trial
Condition Studied Polymyalgia rheumatica (PMR)
Main Objective Determine optimal dosing of Clofutriben with prednisolone for PMR treatment
Secondary Objectives 1. Assess if Clofutriben reduces prednisolone toxicity
2. Characterize Clofutriben’s pharmacological activity
3. Report safety of Clofutriben in PMR patients
Study Design Multiple cohorts testing different dose combinations of prednisolone and Clofutriben
Treatment Duration 28 days (14 days Clofutriben, 14 days placebo)
Primary Endpoints Fibrinogen, erythrocyte sedimentation rate, C-reactive protein levels
Key Inclusion Criteria PMR diagnosis, stable on 10 mg prednisolone, no current PMR relapse
Key Exclusion Criteria Giant cell arteritis, other autoimmune diseases, contraindications to prednisolone

FAQ

  • What is Clofutriben (SPI-62)? Clofutriben, also known as SPI-62, is a new drug being tested in clinical trials for the treatment of polymyalgia rheumatica (PMR) in combination with prednisolone. It is being studied to see if it can help reduce the side effects of prednisolone while maintaining its effectiveness in treating PMR.
  • What is the main goal of this clinical trial? The main goal of this trial is to determine if a prednisolone dose adjustment is necessary when given with Clofutriben (SPI-62) to patients with PMR, and if so, to estimate the appropriate adjustment. The study also aims to see if Clofutriben can reduce prednisolone's side effects and to evaluate its safety and effectiveness in PMR patients.
  • How is the trial structured? The trial is divided into multiple cohorts, each testing different combinations of prednisolone and Clofutriben doses. Participants receive either Clofutriben or a placebo for two weeks each, along with prednisolone. The study includes a screening period, a 28-day treatment period, and a follow-up visit on day 56.
  • Who can participate in this clinical trial? Participants must have a diagnosis of PMR according to specific criteria, be on a stable dose of 10 mg daily oral prednisolone for at least a week before the trial, and have no signs of PMR relapse. People with other autoimmune diseases, giant cell arteritis, or conditions that might interfere with the trial are not eligible.
  • What are the potential benefits of combining Clofutriben with prednisolone? The study aims to determine if Clofutriben can help reduce the toxicity associated with prednisolone while maintaining its effectiveness in treating PMR. If successful, this combination could potentially offer a safer treatment option for PMR patients who require long-term steroid therapy.

Ongoing Clinical Trials on Clofutriben

  • Study of SPI-62 for Treating ACTH-Dependent Cushing’s Syndrome in Patients with Cushing’s Disease or Ectopic ACTH/CRH Secretion

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Romania

  • Study of Prednisolone and SPI-62 for Patients with Polymyalgia Rheumatica

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

Glossary

  • Polymyalgia rheumatica (PMR): A inflammatory disorder that causes muscle pain and stiffness, especially in the shoulders and hips. It typically affects older adults and is often treated with corticosteroids like prednisolone.
  • Prednisolone: A corticosteroid medication commonly used to treat inflammatory conditions like PMR. While effective, it can have significant side effects, especially with long-term use.
  • Clofutriben (SPI-62): An investigational drug being studied for its potential to reduce the side effects of prednisolone while maintaining its effectiveness in treating PMR.
  • Phase II clinical trial: A stage of drug testing that aims to evaluate the effectiveness and safety of a new treatment in a larger group of patients with the condition it's meant to treat.
  • Cohort: A group of participants in a study who share a common characteristic or experience within a defined period.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs to help determine their effectiveness.
  • Giant cell arteritis: An inflammatory condition of blood vessels, often associated with PMR, but excluded from this particular study.
  • Fibrinogen: A protein in the blood that helps in clotting. Its levels are measured in this study as one of the primary endpoints.
  • Erythrocyte sedimentation rate: A blood test that measures how quickly red blood cells settle at the bottom of a test tube, which can indicate inflammation in the body.
  • C-reactive protein: A protein produced by the liver in response to inflammation, used as a marker to monitor inflammatory conditions like PMR.

References

  1. http://clinicaltrials.eu/trial/study-of-prednisolone-and-spi-62-for-patients-with-polymyalgia-rheumatica/