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PICLIDENOSON

Piclidenoson (also known as CF101) is an investigational drug currently being studied in clinical trials for multiple conditions. This oral medication is being evaluated for its effectiveness and safety in treating both COVID-19 infection and moderate-to-severe plaque psoriasis. The trials aim to determine whether Piclidenoson can provide meaningful benefits to patients by reducing symptoms, improving outcomes, and enhancing quality of life. This article explores the current clinical research on Piclidenoson and what it might mean for patients with these conditions.

Table of Contents

What is Piclidenoson?

Piclidenoson, also known as CF101, is an investigational oral medication that is being studied for the treatment of various medical conditions[1]. It is administered as tablets taken by mouth and is currently undergoing clinical trials to evaluate its effectiveness and safety for different diseases[2].

How Piclidenoson Works

Piclidenoson is classified as a selective A3AR agonist[2]. This means it targets and activates a specific receptor in the body called the A3 adenosine receptor (A3AR). These receptors are involved in various biological processes, including inflammation regulation. By activating these receptors, Piclidenoson may help reduce inflammation, which is a key factor in diseases like psoriasis and potentially in the severe symptoms of COVID-19.

Medical Conditions Treated with Piclidenoson

Based on the clinical trials information, Piclidenoson is being investigated for two main conditions:

  • COVID-19: For patients with moderate to severe coronavirus infection[1]
  • Plaque Psoriasis: For patients with moderate-to-severe plaque psoriasis (a chronic skin condition causing red, scaly patches)[2]

Piclidenoson for COVID-19 Treatment

In the context of COVID-19 treatment, Piclidenoson is being studied in a randomized, double-blind, placebo-controlled trial[1]. This means that some patients receive Piclidenoson while others receive a placebo (inactive substance), and neither the patients nor the researchers know who is receiving which treatment until the study is completed.

For COVID-19, the dosage being studied is 2 mg taken orally every 12 hours for up to 28 days, in addition to standard supportive care[1].

The study aims to determine if Piclidenoson can help:

  • Keep patients alive and free of respiratory failure (avoiding the need for mechanical ventilation or other advanced oxygen support)[1]
  • Increase the proportion of patients who can be discharged home without needing supplemental oxygen[1]
  • Improve clinical status according to a standardized scale[1]
  • Reduce the time needed for clinical improvement[1]
  • Decrease the need for mechanical ventilation or ICU admission[1]
  • Shorten hospital stays[1]
  • Reduce the duration of supplemental oxygen need[1]
  • Accelerate viral clearance (how quickly the virus is eliminated from the body)[1]

Piclidenoson for Plaque Psoriasis Treatment

For psoriasis treatment, Piclidenoson is being evaluated in a Phase 3 clinical trial, which is one of the final stages of testing before a medication can be approved for general use[2].

In this study, patients with moderate-to-severe plaque psoriasis are given Piclidenoson 3 mg twice daily[2]. The effectiveness of the treatment is measured using several standardized scales:

  • PASI (Psoriasis Area and Severity Index): A tool used to measure the severity and extent of psoriasis. A PASI 75 response means the patient’s psoriasis has improved by 75% or more[2].
  • sPGA (Static Physician’s Global Assessment): A physician’s rating of the overall severity of a patient’s psoriasis. The goal is to achieve a score of 0 or 1 (clear or almost clear skin) with at least a 2-point improvement from baseline[2].
  • PSSD (Psoriasis Symptoms and Signs Diary): A patient-reported measure of psoriasis symptoms and their impact on quality of life[2].
  • DLQI (Dermatology Life Quality Index): A questionnaire that measures how much a skin problem has affected a patient’s life[2].

For some patients with specific areas affected, additional measurements may include:

  • PSSI (Psoriasis Scalp Severity Index): For patients with scalp involvement[2]
  • NAPSI (Nail Psoriasis Severity Index): For patients with nail involvement[2]

Dosage and Administration

Based on the clinical trials, the dosages being studied are:

  • For COVID-19: 2 mg taken orally every 12 hours for up to 28 days[1]
  • For Plaque Psoriasis: 3 mg taken orally twice daily[2]

In both cases, Piclidenoson is administered as tablets taken by mouth[1][2].

Clinical Trials and Research

Piclidenoson is currently being studied in structured clinical trials. These are scientific studies designed to evaluate the safety and effectiveness of new medications in human subjects.

The COVID-19 trial (NCT04333472) is designed to enroll patients with moderate or severe COVID-19 who are hospitalized[1]. Patients are monitored for up to 29 days to evaluate various outcomes including survival, respiratory status, need for mechanical ventilation, and time to hospital discharge.

The psoriasis trial (NCT06643260) is a more complex study conducted in multiple segments[2]:

  • Segment 1: A 16-week primary efficacy period where patients receive either Piclidenoson or placebo[2]
  • Segment 2 (for eligible patients): Includes three periods:
    1. Period A (Weeks 0-16): Primary efficacy testing[2]
    2. Period B (Weeks 17-32): Patients initially on placebo switch to Piclidenoson[2]
    3. Period C (Weeks 33-52): Some patients who responded well are randomly assigned to either continue Piclidenoson or switch to placebo to test durability of response[2]

After completing the 52-week study, patients may have the opportunity to enroll in a long-term safety and efficacy trial lasting up to an additional 4 years[2].

Safety and Potential Side Effects

As Piclidenoson is still in clinical trials, the full safety profile and all potential side effects are not yet fully established. Both trials are monitoring patients for adverse events (side effects)[1][2].

The COVID-19 trial is specifically monitoring for:

  • Treatment-emergent adverse events[1]
  • Serious adverse events[1]
  • Adverse events leading to withdrawal from the study[1]
  • Abnormalities in laboratory tests or electrocardiograms (ECGs)[1]

Similarly, the psoriasis trial is monitoring for all adverse events throughout the study period[2]. Both trials include regular safety assessments including physical examinations, vital signs monitoring, and laboratory tests.

It’s important to note that the safety monitoring in these trials is thorough and includes measures to protect patient well-being, including stopping rules that would halt a patient’s participation if certain safety concerns arise[1].

Feature COVID-19 Trial (NCT04333472) Plaque Psoriasis Trial (NCT06643260)
Study Design Randomized, double-blind, placebo-controlled Randomized, double-blind, placebo-controlled
Dosage 2 mg every 12 hours 3 mg twice daily
Duration Up to 28 days Up to 52 weeks (with multiple study periods)
Primary Endpoints • Freedom from respiratory failure
• Discharge to home without oxygen
• Adverse events		 • PASI 75 achievement
• sPGA score of 0 or 1
• Adverse events
Key Secondary Endpoints • Clinical status on 8-point scale
• Need for mechanical ventilation
• Time to virus negativity
• Viral load
• Cytokine levels		 • Combined PASI 75 and sPGA improvement
• Quality of life improvements (PSSD, DLQI)
Monitoring Methods • Vital signs
• Respiratory parameters
• Viral shedding
• Clinical laboratory tests
• ECGs		 • PASI score
• sPGA
• Body surface area
• Quality of life assessments
• Clinical laboratory tests
• Mental health questionnaires

FAQ

  • What is Piclidenoson and how does it work? Piclidenoson (also known as CF101) is an oral medication that acts as a selective A3AR agonist. While the exact mechanism isn't fully explained in the trial information, A3AR agonists typically work by targeting specific receptors involved in inflammation. In the COVID-19 trial, it's being tested at 2 mg taken every 12 hours, while in the psoriasis trial, a 3 mg dose twice daily is being studied. It comes in tablet form and is taken by mouth.
  • What conditions is Piclidenoson being studied for? Based on the clinical trial data provided, Piclidenoson is currently being studied for two main conditions: 1) Moderate COVID-19 infection, where it's being evaluated for its ability to prevent respiratory failure and improve outcomes in hospitalized patients, and 2) Moderate-to-severe plaque psoriasis, where it's being tested for its effectiveness in reducing psoriasis symptoms and improving skin appearance and quality of life.
  • How are the clinical trials for Piclidenoson designed? Both trials are randomized, double-blind, and placebo-controlled, which means participants are randomly assigned to either receive Piclidenoson or a placebo, and neither the participants nor the researchers know who is receiving which treatment during the study. The COVID-19 trial treats patients for up to 28 days, while the psoriasis trial is more complex with multiple segments and periods lasting up to 52 weeks, including a primary efficacy period, a crossover period, and a randomized withdrawal period to test long-term effects.
  • What are the primary outcomes being measured in these trials? For the COVID-19 trial, primary outcomes include the proportion of patients alive and free of respiratory failure at Day 29, the proportion discharged home without needing supplemental oxygen, and treatment-related adverse events. For the psoriasis trial, primary outcomes focus on the percentage of patients achieving at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75), achieving a Static Physician's Global Assessment (sPGA) score of 0 or 1 with at least a 2-point improvement from baseline, and the proportion of subjects experiencing adverse events.
  • Are there any known side effects of Piclidenoson? The clinical trial information doesn't specifically list known side effects of Piclidenoson. However, both trials are closely monitoring safety through adverse event reporting, vital signs assessment, electrocardiograms (ECGs), and clinical laboratory tests. The psoriasis trial also includes mental health monitoring through questionnaires like the Patient Health Questionnaire-9 (PHQ-9) and Columbia Suicide Severity Rating Scale (C-SSRS). Safety is a primary outcome in both trials, indicating that understanding the drug's side effect profile is a key objective of the research.

Ongoing Clinical Trials on PICLIDENOSON

  • Study on the Effects and Safety of Piclidenoson for Patients with Moderate-to-Severe Plaque Psoriasis

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Greece Poland

Glossary

  • Piclidenoson (CF101): An investigational drug being studied as a treatment for COVID-19 and plaque psoriasis. It is a selective A3AR agonist that is taken orally in tablet form.
  • A3AR agonist: A type of medication that activates the A3 adenosine receptor, which may help reduce inflammation in the body.
  • Randomized, double-blind, placebo-controlled trial: A type of clinical study where participants are randomly assigned to receive either the study medication or a placebo (inactive substance). Neither the participants nor the researchers know who is receiving which treatment until the study is completed.
  • Plaque psoriasis: A chronic skin condition characterized by patches of raised, reddened skin covered with silvery scales, typically affecting the elbows, knees, scalp, and lower back.
  • Standard supportive care (SSC): The regular care provided to patients with a particular condition, which may include treatments to manage symptoms but not specifically target the underlying disease.
  • Respiratory failure: A condition where the lungs cannot properly exchange oxygen and carbon dioxide, often requiring mechanical ventilation or other breathing support.
  • Mechanical ventilation: The use of a machine to help a patient breathe when they cannot breathe adequately on their own.
  • Extracorporeal membrane oxygenation (ECMO): A life support technique that uses a machine to oxygenate blood outside the body when the heart and lungs are severely damaged.
  • Psoriasis Area and Severity Index (PASI): A tool used to measure the severity of psoriasis based on the area of skin affected and the appearance of the psoriasis plaques.
  • PASI 75: A 75% or greater improvement in the PASI score from baseline, indicating significant improvement in psoriasis symptoms.
  • Static Physician's Global Assessment (sPGA): A scale used by doctors to assess the overall severity of a patient's psoriasis at a specific point in time.
  • Body Surface Area (BSA): A measurement of the percentage of the body affected by psoriasis.
  • Dermatology Life Quality Index (DLQI): A questionnaire that measures how much a skin problem affects a patient's quality of life.
  • Psoriasis Symptoms and Signs Diary (PSSD): A patient-reported tool that tracks the symptoms and signs of psoriasis over time.
  • Psoriasis Scalp Severity Index (PSSI): A measurement tool specifically designed to assess the severity of scalp psoriasis.
  • Nail Psoriasis Severity Index (NAPSI): A system used to evaluate the severity of nail psoriasis.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the study medication.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or has other significant medical consequences.
  • Cytokines: Small proteins released by cells that have specific effects on cell interactions and communications, particularly in immune responses.
  • Interim analysis: A statistical analysis performed before a study is complete to evaluate if the study should continue, be modified, or be stopped early.
  • Futility analysis: An analysis conducted during a clinical trial to determine if it is unlikely that the study will demonstrate a significant benefit of the treatment, potentially leading to early study termination.

References