#1 Clinical Trials Search in Europe

Deucravacitinib

Deucravacitinib is an emerging drug being studied in clinical trials for its potential to treat a variety of skin conditions. This article explores the ongoing research into deucravacitinib’s effectiveness and safety for conditions such as psoriasis, lichen planopilaris, pyoderma gangrenosum, and other inflammatory skin disorders. We’ll examine the key findings from several clinical trials and what they may mean for patients with these challenging skin conditions.

Table of Contents

What is Deucravacitinib?

Deucravacitinib is a new medication being studied for the treatment of various skin conditions. It’s also known by its brand name SOTYKTU® and the code name BMS-986165[2]. This drug belongs to a class of medications called Tyrosine kinase 2 (TYK2) blockers, which work by targeting specific parts of the immune system involved in skin inflammation[1].

What Conditions Does Deucravacitinib Treat?

Deucravacitinib is being studied for several skin conditions, including:

  • Plaque Psoriasis: A common skin condition characterized by red, scaly patches[3]
  • Nail Psoriasis: A form of psoriasis that affects the fingernails and toenails[4]
  • Pyoderma Gangrenosum (PG): A rare skin condition that causes large, painful sores[5]
  • Lichen Planopilaris (LPP): An inflammatory condition that leads to hair loss[6]
  • Pityriasis Rubra Pilaris (PRP): A rare skin disorder causing redness and scaling[7]
  • Palmoplantar Pustulosis (PPP): A condition causing pustules on the palms and soles[8]

How Does Deucravacitinib Work?

Deucravacitinib works by blocking a specific enzyme in the body called Tyrosine kinase 2 (TYK2). This enzyme plays a role in the immune system’s inflammatory response. By inhibiting TYK2, Deucravacitinib helps reduce inflammation in the skin, which can improve symptoms of various skin conditions[1].

How is Deucravacitinib Administered?

Deucravacitinib is typically taken as an oral medication. In most studies, it’s administered as a 6 mg tablet, taken either once or twice daily[4][6]. The exact dosage and frequency may vary depending on the condition being treated and the specific study protocol.

Effectiveness of Deucravacitinib

The effectiveness of Deucravacitinib is being evaluated in various clinical trials. Researchers are looking at several measures to determine how well the drug works, including:

  • Psoriasis Area and Severity Index (PASI): This scale measures the severity and extent of psoriasis. A reduction in PASI score indicates improvement[3].
  • Static Physician’s Global Assessment (sPGA): This tool helps doctors assess the overall severity of a skin condition[3].
  • Body Surface Area (BSA): This measures the percentage of skin affected by a condition[3].
  • Dermatology Life Quality Index (DLQI): This questionnaire assesses how skin conditions affect a person’s quality of life[8].

Potential Side Effects

As with any medication, Deucravacitinib may cause side effects. Clinical trials are carefully monitoring participants for any adverse events. Common areas of observation include:

  • Changes in vital signs
  • Abnormalities in electrocardiogram (ECG) readings
  • Changes in physical examination findings
  • Abnormalities in clinical laboratory tests[2]

It’s important to note that the full range of potential side effects may not be known until more extensive studies are completed.

Ongoing Research

Deucravacitinib is still being studied in various clinical trials. Some areas of ongoing research include:

  • Long-term safety and effectiveness in different skin conditions
  • Its impact on quality of life for patients with skin disorders
  • Its effectiveness compared to other treatments
  • Its use in combination with other therapies
  • Its presence in breast milk, which is important for understanding its safety in breastfeeding mothers[9]

As research continues, we may learn more about how Deucravacitinib can be used to help patients with various skin conditions.

Aspect Details
Drug Name Deucravacitinib (also known as BMS-986165)
Mechanism of Action Tyrosine kinase 2 (TYK2) inhibitor
Administration Oral tablet, typically 6 mg daily or twice daily
Conditions Studied Plaque psoriasis, nail psoriasis, lichen planopilaris, pyoderma gangrenosum, palmoplantar pustulosis, pityriasis rubra pilaris
Primary Outcome Measures PASI scores, PGA scores, condition-specific indices (e.g., mNAPSI for nail psoriasis)
Secondary Outcome Measures Quality of life (DLQI, Skindex-16), itch and pain scores (VAS), safety assessments
Trial Durations Typically 24-52 weeks, with some longer-term follow-up
Safety Monitoring Adverse events, vital signs, laboratory tests, physical examinations
Patient Populations Adults with moderate to severe forms of the studied skin conditions
Potential Benefits Improvement in skin condition severity, quality of life, and symptom relief

FAQ

  • What is deucravacitinib and how does it work? Deucravacitinib is a medication that works by blocking an enzyme called Tyrosine kinase 2 (TYK2). This helps reduce inflammation in the body, which is thought to be beneficial for various skin conditions. It's taken orally, usually as a tablet.
  • What skin conditions is deucravacitinib being studied for? Clinical trials are investigating deucravacitinib for several skin conditions, including plaque psoriasis, nail psoriasis, lichen planopilaris, pyoderma gangrenosum, palmoplantar pustulosis, and pityriasis rubra pilaris.
  • How is the effectiveness of deucravacitinib measured in these trials? Researchers use various scales to measure effectiveness, such as the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA), and condition-specific measures like the modified Nail Psoriasis Severity Index (mNAPSI) for nail psoriasis.
  • Are there any side effects associated with deucravacitinib? While specific side effects vary between trials, researchers are monitoring for adverse events, changes in vital signs, and abnormalities in laboratory tests. The safety profile is being carefully evaluated in each study.
  • How long do these clinical trials typically last? The duration of the trials varies, but many last between 24 to 52 weeks. Some studies include longer follow-up periods to assess long-term effectiveness and safety.

Ongoing Clinical Trials on Deucravacitinib

  • Study on the Effectiveness and Safety of Deucravacitinib for Patients with Active Systemic Lupus Erythematosus (SLE)

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Czechia Greece Hungary Poland Portugal +1

  • Long-term safety study of deucravacitinib compared to ustekinumab in adults with moderate to severe plaque psoriasis

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +6

  • Study of deucravacitinib compared to placebo in adolescents aged 12-17 years with moderate to severe plaque psoriasis

    Recruiting

    1 1
    Investigated drugs:
    Belgium Germany Hungary Italy Poland Romania +1

  • Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Italy Romania Spain

  • Study on the Effects of Deucravacitinib for Adults with Inflammatory Skin Conditions (Epidermolysis Bullosa Simplex and Congenital Ichthyoses)

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of Deucravacitinib for Adults with Active Sjogren’s Syndrome

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Finland France Germany +9

  • Study on Deucravacitinib for Children with Moderate to Severe Plaque Psoriasis

    Recruiting

    1 1
    Investigated drugs:
    France Germany Poland Romania Spain

  • Study on the Effectiveness and Safety of JNJ-77242113 and Deucravacitinib for Adults with Moderate to Severe Plaque Psoriasis

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Germany Hungary Italy Poland Romania Spain

  • Study on the Effectiveness of JNJ-77242113 and Deucravacitinib for Treating Moderate to Severe Plaque Psoriasis in Adults

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France Germany Hungary Italy Poland Spain

  • Comparison of zasocitinib and deucravacitinib in adults with moderate to severe plaque psoriasis

    Not recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Czechia France Latvia Poland

Glossary

  • Deucravacitinib: An oral medication that inhibits Tyrosine kinase 2 (TYK2), used to treat various inflammatory skin conditions.
  • Psoriasis Area and Severity Index (PASI): A tool used to measure the severity and extent of psoriasis, considering factors like redness, thickness, and scaling of skin lesions.
  • Physician's Global Assessment (PGA): A standardized method used by healthcare professionals to evaluate the overall severity of a skin condition.
  • Lichen Planopilaris: A type of scarring hair loss that results in permanent hair loss and inflammation of the scalp.
  • Pyoderma Gangrenosum: A rare skin condition that causes large, painful sores (ulcers) to develop on the skin, most often on the legs.
  • Palmoplantar Pustulosis: A chronic skin condition characterized by the formation of pustules on the palms of the hands and soles of the feet.
  • Pityriasis Rubra Pilaris: A rare skin disorder that causes inflammation and shedding of the skin, often with reddish-orange, scaly patches.
  • Dermatology Life Quality Index (DLQI): A questionnaire used to measure the impact of skin diseases on a patient's quality of life.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, such as pain or itch intensity.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT05858645
  2. https://clinicaltrials.gov/study/NCT06566768
  3. https://clinicaltrials.gov/study/NCT06512337
  4. https://clinicaltrials.gov/study/NCT05124080
  5. https://clinicaltrials.gov/study/NCT05821374
  6. https://clinicaltrials.gov/study/NCT06091956
  7. https://clinicaltrials.gov/study/NCT06444399
  8. https://clinicaltrials.gov/study/NCT05710185
  9. https://clinicaltrials.gov/study/NCT06476834