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Abrocitinib

Clinical trials are investigating Abrocitinib in people with eczema and chronic hand eczema. These studies look at safety, how well the treatment works, and how well people can tolerate it. The trials include children, adolescents, and adults with moderate to severe disease.

Table of Contents

Clinical trial overview

The source data shows that Abrocitinib is being studied in interventional studies, which means researchers give a treatment and then measure the results.[1] These trials focus on skin diseases that can be long-lasting and hard to control, especially eczema and chronic hand eczema.[1]

The studies are designed to check safety, efficacy (how well the treatment works), and tolerability (how well people can stay on the treatment).[1] Some trials compare Abrocitinib with placebo, and some follow people for longer periods of time.[1]

Conditions being studied

One trial studies moderate to severe chronic hand eczema, a long-term skin problem that mainly affects the hands.[1] Another trial studies moderate-to-severe atopic dermatitis, which is another name for eczema used in the trial records.[2]

The atopic dermatitis studies include both children and older patients, showing that the research is aimed at different age groups with similar skin disease severity.[2][3] One study also looks at patients who need second-line systemic therapy, which means treatment used when first treatment choices are not enough.[4]

Who can join the studies

The trials include several age groups, depending on the study.[2][3][5]

  • Children 6 to less than 12 years old with moderate-to-severe atopic dermatitis can join one Phase 3 study.[2]

  • Children aged 2 years and older with moderate to severe eczema can join a long-term safety study.[3]

  • Patients aged 12 years or older with moderate to severe atopic dermatitis can join a long-term study that follows people from earlier trials.[5]

  • Patients with moderate to severe chronic hand eczema can join the Phase 2 study focused on hand disease.[1]

These details show that the research is not limited to one age group and is being tested in both younger children and older patients.[2][3][5]

Trial phases and study designs

The source data includes one Phase 2 trial and several Phase 3 trials.[1][2][3][4][5]

Phase 2 trials usually look for early signs that a treatment may help and continue to check safety.[1] Phase 3 trials are larger and often compare the study medicine with placebo or other treatments to better understand benefit and safety.[2][3][5]

The chronic hand eczema trial is Phase 2 and completed with 84 participants.[1] The other trials are Phase 3, including completed and authorised studies with larger enrollment numbers.[2][3][5]

Main outcomes and what they mean

The chronic hand eczema trial measured the percent change from baseline in hand mTLSS at Week 16.[1] Baseline means the starting point before treatment begins, and Week 16 means the result was checked after 16 weeks.[1]

The child atopic dermatitis trial measured whether the skin became clear or almost clear on the validated Investigator’s Global Assessment, or vIGA, and whether the EASI score improved by at least 75% at Week 12.[2] EASI-75 means a strong improvement in eczema severity score.[2]

The study on treatment optimization measured the percentage of patients with primary non-response, which means the treatment did not reach the expected improvement, defined here as failing to achieve EASI-75 at week 16.[4] This study also aims to build prediction models using genetic, biochemical, immunological, clinical, and demographic data.[4]

The long-term pediatric safety study measures treatment-emergent adverse events, serious adverse events, and adverse events that lead to stopping the study treatment.[3] The long-term study in patients aged 12 years or older measures treatment-emergent adverse events, serious adverse events, clinical laboratory changes, ECG changes, and vital signs.[5]

Study snapshot

  • 2023-504539-42-00: Phase 2, completed, 84 participants, moderate to severe chronic hand eczema, with the main outcome measured at Week 16.[1]

  • NCT06807268: Phase 3, authorised, 150 participants, children 6 to less than 12 years old with moderate-to-severe atopic dermatitis, comparing Abrocitinib with placebo plus background topical medicine.[2]

  • 2023-506165-62-00: Phase 3, authorised, atopic dermatitis, focused on treatment selection and prediction models for second-line systemic therapy.[4]

  • NCT06807281: Phase 3, authorised, 500 participants, children aged 2 years and older with moderate to severe eczema, focused on long-term safety.[3]

  • 2023-508955-37-00: Phase 3, completed, 2680 participants, patients aged 12 years or older with moderate to severe atopic dermatitis, focused on long-term safety with or without topical treatments.[5]

Trial IDPhaseCondition studiedStatusEnrollment
2023-504539-42-00Phase 2Moderate to severe chronic hand eczemaCompleted84
NCT06807268Phase 3Moderate-to-Severe Atopic DermatitisAuthorised150
2023-506165-62-00Phase 3Atopic dermatitisAuthorisedNot stated
NCT06807281Phase 3Moderate-to-Severe Atopic DermatitisAuthorised500
2023-508955-37-00Phase 3Moderate to severe atopic dermatitisCompleted2680

FAQ

  • What conditions are being studied with Abrocitinib? The trials in the source data study moderate to severe atopic dermatitis, also called eczema, and moderate to severe chronic hand eczema. These are long-lasting skin conditions that can cause itching, redness, and inflammation.
  • Who can take part in these trials? The trials include different age groups. Some studies are for children from 2 years and older, one is for children 6 to less than 12 years old, and others are for adolescents and adults aged 12 years or older.
  • What do the trials want to find out? The main goals are to check safety, efficacy, and tolerability. In simple words, the studies look at whether Abrocitinib helps improve skin symptoms, whether it is safe, and whether people can stay on treatment.
  • What phases are the Abrocitinib trials? The source data includes Phase 2 and Phase 3 trials. Phase 2 studies usually explore early signs of benefit, while Phase 3 studies are larger and often compare treatment with placebo or other treatments.
  • What kinds of results are measured in these trials? The trials measure skin improvement scores, safety events, and treatment response over time. Examples include changes in eczema scores, clear or almost clear skin, and reports of side effects that lead to stopping treatment.

Ongoing Clinical Trials on Abrocitinib

  • Study of abrocitinib oral suspension for children aged 2 years and older with moderate to severe atopic dermatitis to evaluate long-term safety and effectiveness

    Recruiting

    1 1 1
    Investigated drugs:
    Germany Hungary Poland Spain

  • Effectiveness and Safety of Abrocitinib in Children 6 to Under 12 Years with Moderate-to-Severe Atopic Dermatitis

    Recruiting

    1 1
    Investigated drugs:
    Germany Hungary Poland Spain

  • Study on Atopic Dermatitis Treatment with Baricitinib, Tralokinumab, Abrocitinib, Upadacitinib, and Dupilumab for Patients Needing Second-Line Systemic Therapy

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on Long-Term Safety and Effectiveness of Abrocitinib for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

    Not recruiting

    1 1 1
    Investigated drugs:
    Hungary Poland Spain

  • Study on Abrocitinib for Patients with Moderate to Severe Chronic Hand Eczema Unresponsive to Corticosteroids

    Not recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Atopic dermatitis: A long-term skin disease also called eczema. It can cause dry, itchy, inflamed skin.
  • Chronic hand eczema: A lasting form of eczema that mainly affects the hands and can make the skin sore, cracked, or itchy.
  • Phase 2: A trial stage that looks at early signs of whether a treatment works and continues to check safety.
  • Phase 3: A later and usually larger trial stage that compares a treatment with placebo or other treatments and checks safety and benefit.
  • Interventional study: A study where researchers give a treatment to participants and then measure the results.
  • Placebo: A look-alike treatment that does not have the study medicine. It helps researchers compare results fairly.
  • EASI-75: A skin score result showing at least 75% improvement in eczema severity. Higher improvement means better skin control.
  • vIGA: Validated Investigator’s Global Assessment. This is a doctor-rated scale that shows how clear or severe the skin looks.
  • mTLSS: A hand skin score used in the chronic hand eczema trial to measure how severe the hand eczema is.
  • Adverse event: A medical problem that happens during a study. It may or may not be caused by the treatment.
  • Serious adverse event: A severe medical problem during a study that can be dangerous, need hospital care, or cause major harm.
  • Treatment-emergent adverse event: A side effect or medical problem that starts or gets worse after treatment begins.

References