Treatment of moderate-to-severe Atopic dermatitis
Conditions
Brief summary
1. Ctrough at Week 16., 2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
Detailed description
1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16)., 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16)., 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68)., 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68)., 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 7. Change in SCORAD from Week 0 to Week 68., 8. Change in POEM from Week 0 to Week 68., 9. Change in EASI from Week 0 to Week 68.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ctrough at Week 16., 2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16)., 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16)., 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68)., 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68)., 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 7. Change in SCORAD from Week 0 to Week 68., 8. Change in POEM from Week 0 to Week 68., 9. Change in EASI from Week 0 | — |
Countries
Czechia, France, Netherlands, Spain