Atopic dermatitis
Conditions
Brief summary
Mean change from baseline in EASI score after 12 weeks of treatment with BP1.7881 compared to placebo.
Detailed description
Proportion of patients who achieved an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) with an improvement from baseline ≥2 points, Proportion of patients who achieved 75% improvement in EASI score, Proportion of patients who achieved 90% improvement in EASI score, Percent change from baseline in peak pruritus numerical rating scale (Peak Pruritus -NRS), Proportion of patients with improvement (reduction) of the Peak Pruritus -NRS ≥4 at all scheduled time points, Mean change in pruritus via the 5-D Pruritus Scale
Interventions
DRUGmatching film-coating placebo tablet
Sponsors
Bioprojet Pharma, Bioprojet Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in EASI score after 12 weeks of treatment with BP1.7881 compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) with an improvement from baseline ≥2 points, Proportion of patients who achieved 75% improvement in EASI score, Proportion of patients who achieved 90% improvement in EASI score, Percent change from baseline in peak pruritus numerical rating scale (Peak Pruritus -NRS), Proportion of patients with improvement (reduction) of the Peak Pruritus -NRS ≥4 at all scheduled time points, Mean change in pruritus via the 5-D Pruritus Scale | — |
Countries
France, Germany, Poland
Outcome results
None listed