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Vibozilimod

Vibozilimod, also known as SCD-044, is an innovative oral medication currently undergoing clinical trials for the treatment of moderate to severe plaque psoriasis and atopic dermatitis. These phase IIb studies aim to evaluate the safety and effectiveness of Vibozilimod in patients suffering from these chronic skin conditions. The trials are designed to assess the drug’s potential to significantly improve symptoms and quality of life for individuals with these challenging dermatological disorders.

Table of Contents

What is VIBOZILIMOD?

VIBOZILIMOD, also known as SCD-044, is a new medication being developed to treat certain skin conditions[1][2]. It is currently undergoing clinical trials to evaluate its safety and effectiveness. VIBOZILIMOD is classified as a selective immunosuppressive agent, which means it works by modulating the immune system to reduce inflammation and other symptoms associated with certain skin diseases.

What Conditions Does VIBOZILIMOD Treat?

VIBOZILIMOD is being studied for the treatment of two main skin conditions:

  1. Moderate to severe plaque psoriasis: This is a chronic autoimmune condition that causes rapid buildup of skin cells, resulting in scaly, itchy, and inflamed patches on the skin[1].
  2. Moderate to severe atopic dermatitis: Also known as eczema, this is a chronic inflammatory skin condition characterized by dry, itchy, and inflamed skin[2].

How Does VIBOZILIMOD Work?

While the exact mechanism of action is not fully described in the provided information, VIBOZILIMOD belongs to a class of drugs called selective immunosuppressive agents[1][2]. These medications work by targeting specific components of the immune system to reduce inflammation and other symptoms associated with autoimmune skin conditions. By modulating the immune response, VIBOZILIMOD aims to alleviate the symptoms and improve the overall condition of patients with psoriasis and atopic dermatitis.

Clinical Trials and Effectiveness

VIBOZILIMOD is currently being evaluated in Phase IIb clinical trials for both plaque psoriasis and atopic dermatitis[1][2]. These trials are designed to assess the drug’s efficacy and safety. The main objectives of these studies include:

  • For plaque psoriasis: To determine the proportion of patients who achieve at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment[1]. This is known as PASI75 and is a standard measure of effectiveness in psoriasis treatments.
  • For atopic dermatitis: To evaluate the proportion of patients who achieve at least a 75% improvement in the Eczema Area and Severity Index (EASI) score after 16 weeks of treatment[2]. This is referred to as EASI75 and is a common measure of effectiveness in atopic dermatitis treatments.

These trials will help determine how well VIBOZILIMOD works compared to a placebo and at what doses it is most effective.

Dosage and Administration

VIBOZILIMOD is being tested in tablet form and is taken orally. The clinical trials are evaluating different dosage strengths, including:

  • 0.1 mg tablets
  • 0.3 mg tablets
  • 0.6 mg tablets
  • 1.0 mg tablets

The exact dosing regimen and duration of treatment may vary depending on the condition being treated and the results of the ongoing clinical trials[1][2].

Who is Eligible for VIBOZILIMOD Treatment?

As VIBOZILIMOD is still in clinical trials, eligibility for treatment is currently limited to study participants. The general criteria for participation in these trials include:

  • Adults aged 18 years or older
  • Diagnosed with moderate to severe plaque psoriasis or atopic dermatitis for at least 6 months or 1 year, respectively
  • For psoriasis: at least 10% body surface area affected, a PASI score of 12 or higher, and an Investigator’s Global Assessment (IGA) score of at least 3 (indicating moderate disease)[1]
  • For atopic dermatitis: meeting the Eichenfield revised criteria of Hanifin and Rajka for diagnosis[2]
  • Not pregnant or breastfeeding
  • No history of certain medical conditions, such as uveitis (inflammation of the middle layer of the eye)

Potential Side Effects

As VIBOZILIMOD is still in clinical trials, the full range of potential side effects is not yet known. The ongoing studies will help identify any adverse reactions associated with the medication. It’s important to note that all medications can have side effects, and the benefits and risks should be carefully considered under the guidance of a healthcare professional.

Patients participating in the clinical trials will be closely monitored for any adverse effects throughout the study period[1][2].

Aspect Psoriasis Trial Atopic Dermatitis Trial
Trial Phase Phase IIb Phase IIb
Main Objective Assess PASI75 at Week 16 Assess EASI75 at Week 16
Inclusion Criteria Adults ≥18 years, plaque psoriasis for ≥6 months, BSA ≥10%, PASI ≥12 Adults ≥18 years, atopic dermatitis for ≥1 year
Dosages Tested 0.1 mg, 0.3 mg, 0.6 mg, 1.0 mg 0.1 mg, 0.3 mg, 0.6 mg, 1.0 mg
Administration Oral tablets Oral tablets
Treatment Duration Up to 52 weeks Up to 32 weeks

FAQ

  • What is Vibozilimod? Vibozilimod, also known as SCD-044, is a new oral medication being studied for the treatment of moderate to severe plaque psoriasis and atopic dermatitis. It belongs to a class of drugs called selective immunosuppressive agents.
  • What conditions is Vibozilimod being tested for? Vibozilimod is currently being tested in clinical trials for two main conditions: moderate to severe plaque psoriasis and moderate to severe atopic dermatitis.
  • How is the effectiveness of Vibozilimod measured in these trials? For psoriasis, effectiveness is measured by the proportion of patients showing at least 75% improvement in the Psoriasis Area and Severity Index (PASI) at Week 16. For atopic dermatitis, it's measured by the proportion of patients showing at least 75% improvement in the Eczema Area and Severity Index (EASI) at Week 16.
  • Who can participate in these clinical trials? Generally, participants must be adults (18 years or older) with a diagnosis of either moderate to severe plaque psoriasis or atopic dermatitis. Specific eligibility criteria may vary between the trials, but typically include factors such as disease severity and duration.
  • How is Vibozilimod administered in these trials? Vibozilimod is administered orally in tablet form. The trials are testing various dosages, including 0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg tablets, to determine the most effective and safe dose.

Ongoing Clinical Trials on Vibozilimod

  • Study on the Effectiveness and Safety of Vibozilimod for Adults with Moderate to Severe Plaque Psoriasis

    Not recruiting

    2 1
    Investigated drugs:
    Estonia Poland

  • Study on the Effects of Vibozilimod for Adults with Moderate to Severe Atopic Dermatitis

    Not recruiting

    2 1
    Investigated drugs:
    Estonia Poland

Glossary

  • Plaque Psoriasis: A common form of psoriasis characterized by raised, red patches covered with a silvery white buildup of dead skin cells, typically appearing on the scalp, knees, elbows, and lower back.
  • Atopic Dermatitis: A chronic, itchy skin condition also known as eczema, characterized by red, inflamed, and itchy skin.
  • PASI (Psoriasis Area and Severity Index): A tool used to measure the severity and extent of psoriasis, taking into account the degree of redness, thickness, and scaling of psoriatic lesions.
  • EASI (Eczema Area and Severity Index): A tool used to measure the extent and severity of atopic dermatitis, considering factors such as redness, thickness, scratching, and the area of skin affected.
  • Selective Immunosuppressive Agents: A class of drugs that suppress specific parts of the immune system, often used to treat autoimmune diseases and inflammatory conditions.
  • Phase IIb Study: A stage of clinical research that aims to determine the effectiveness and optimal dosage of a new drug, typically involving a larger group of patients than earlier phases.
  • vIGA (Validated Investigator Global Assessment): A scale used by healthcare professionals to assess the overall severity of a skin condition, often used in clinical trials for dermatological treatments.
  • BSA (Body Surface Area): A measurement used to determine the percentage of the body affected by a skin condition, often used in assessing the severity of psoriasis or other skin disorders.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-vibozilimod-for-adults-with-moderate-to-severe-plaque-psoriasis/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-vibozilimod-for-adults-with-moderate-to-severe-atopic-dermatitis/