Atopic Dermatitis
Conditions
Brief summary
Percentage of participants achieving EASI score ≤7 at Week 24
Detailed description
1. Percentage of participants achieving EASI score ≤7, EASI ≤5, and EASI ≤3 by visit, 2. Percentage of participants achieving EASI 75, and EASI 90 by visit, 3. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points by visit, 4. Percentage of participants achieving SCORAD 75 and SCORAD 90 by visit, 5. Percentage change from baseline in mTLSS (hands) from baseline by visit, 6. Percentage of participants with a Face IGA score of 0 or 1 and a reduction ≥2 points by visit, 7. Percentage of participants with Pruritus NRS ≥4 at baseline achieving ≥4-point improvement in Pruritus NRS from baseline by visit, 8. Percentage of participants achieving DLQI 0-1 by visit, 9. Percentage of participants with DLQI ≥4 at baseline achieving ≥4-point improvement in DLQI from baseline by visit, 10. Percentage of participants achieving cDLQI 0-1 by visit, 11. Percentage of participants with cDLQI ≥6 at baseline achieving ≥6-point improvement in cDLQI from baseline by visit, 12. Percentage of participants with a Sleep-Loss Scale of ≥2 points at baseline who achieve at least 2-point reduction by visit, 13. Percentage of participants with POEM ≥4 at baseline achieving ≥4-point improvement in POEM from baseline by visit, 14. Itch Controlled Days questionnaire score by visit, 15. TSQM-9 by visit
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving EASI score ≤7 at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving EASI score ≤7, EASI ≤5, and EASI ≤3 by visit, 2. Percentage of participants achieving EASI 75, and EASI 90 by visit, 3. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points by visit, 4. Percentage of participants achieving SCORAD 75 and SCORAD 90 by visit, 5. Percentage change from baseline in mTLSS (hands) from baseline by visit, 6. Percentage of participants with a Face IGA score of 0 or 1 and a reduction ≥2 points by visit, 7. Percentage of participants with Pruritus NRS ≥4 at baseline achieving ≥4-point improvement in Pruritus NRS from baseline by visit, 8. Percentage of participants achieving DLQI 0-1 by visit, 9. Percentage of participants with DLQI ≥4 at baseline achieving ≥4-point improvement in DLQI from baseline by visit, 10. Percentage of participants achieving cDLQI 0-1 by visit, 11. Percentage of participants with cDLQI ≥6 at baseline achieving ≥6-point improvement in cDLQI from baseline by visit, 12. Perc | — |
Countries
Germany, Netherlands