Anb032

Clinical trials are investigating Anb032 in people with moderate to severe atopic dermatitis. These studies aim to check whether Anb032 is effective and safe compared with placebo, and they measure skin improvement over time.

Table of contents

Trial overview

The trial data show two Phase 2 studies of Anb032 in people with atopic dermatitis, a long-lasting skin condition also called eczema.[1][2] Both studies were designed to assess clinical efficacy, which means whether the treatment helps improve the disease, and to compare Anb032 with placebo.[1][2]

Study design and groups

Both trials were interventional studies, so researchers assigned study treatments and then measured what happened.[1][2] The study groups included Anb032, placebo, and skin treatments such as hydrocortisone and alclometasone.[1][2] In one trial, Anb032 was given as a subcutaneous injection, which means an injection under the skin.[1]

Who could participate

The studies were planned for subjects with moderate to severe atopic dermatitis, meaning the skin disease was not mild and could have a bigger effect on daily life.[1][2] The trial data do not list more detailed entry rules such as age limits or other health conditions.[1][2]

What was measured

The main outcome in one study was the proportion of subjects who reached EASI-75 at Week 14, which means at least a 75% improvement from the starting skin score.[1] The other study measured the mean change in EASI at Week 14, which shows the average change in eczema severity from the start of the trial.[2] EASI stands for Eczema Area and Severity Index, a score used to track how much skin is affected and how severe it is.[1][2]

Trial status and size

One Anb032 trial was completed and enrolled 161 subjects.[1] The other trial was withdrawn and had planned enrollment of 160 subjects.[2] These details show that the program included a similar number of participants in both studies, but only one study reached completion.[1][2]

Patient terms explained

Placebo means a look-alike treatment without the active study drug, used so researchers can compare results fairly.[1][2] Baseline means the starting point before treatment begins, and Week 14 is the time point used to judge the main results in these studies.[1][2] Cutaneous use means applied to the skin, while subcutaneous injection means given under the skin.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-503522-40-01 Phase 2 Atopic Dermatitis Completed 161
2023-503522-40-00 Phase 2 Atopic Dermatitis Withdrawn 160

Ongoing Clinical Trials on Anb032

  • Study on the Effectiveness and Safety of ANB032, Hydrocortisone, and Alclometasone Dipropionate for Patients with Moderate to Severe Atopic Dermatitis

    Not yet recruiting

    2 1 1 1
    Czechia Poland
  • Study on the Effectiveness and Safety of ANB032, Betamethasone Dipropionate, and Hydrocortisone for Patients with Moderate to Severe Atopic Dermatitis

    Not recruiting

    2 1 1 1
    Czechia Poland

Glossary

  • Atopic dermatitis: A long-term skin condition that can cause dry, itchy, and inflamed skin. It is also called eczema.
  • Moderate to severe: This means the condition is more than mild and may affect daily life more strongly.
  • Phase 2: A stage of clinical research that looks at whether a treatment may work and continues to monitor safety.
  • Interventional study: A study where researchers give a treatment and compare what happens in different groups.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Subcutaneous injection: An injection given under the skin.
  • Cutaneous use: Applied directly to the skin.
  • EASI: Eczema Area and Severity Index, a score that measures how much eczema is present and how serious it is.
  • EASI-75: A result showing at least a 75% improvement in the EASI score from the start of the study.
  • Baseline: The starting point before treatment begins.
  • Week 14: The study visit or time point 14 weeks after the start of the trial.

References

  1. https://clinicaltrials.gov/study/2023-503522-40-01
  2. https://clinicaltrials.gov/study/2023-503522-40-00