Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
Фаза 2
Завершено
NCT05018806
| Заболевание | Atopic Dermatitis |
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| Фаза | Фаза 2 |
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| Спонсор | Sanofi |
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| Статус | Завершено |
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| Участники | 124 участн. |
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| Вмешательство | Rilzabrutinib |
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| Дата начала | 9.09.2021 |
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| Дата завершения | 23.06.2023 |
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| Публикация результатов | 13.07.2026 |
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Кратко
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical corticosteroids (TCS). The total study duration per participant was expected to be approximately 21 weeks, including up to 4 weeks of screening, 16 weeks of on-treatment double-blind period, 1 week of post-treatment follow-up.
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Baseline (Day 1) to Week 16 · Percent change
| BID Cohort: Placebo | -47.33 ± 9.77 Percent change |
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| BID Cohort: Rilzabrutinib | -53.57 ± 8.25 Percent change |
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| TID Cohort: Placebo | -43.33 ± 6.99 Percent change |
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| TID Cohort: Rilzabrutinib | -47.21 ± 6.26 Percent change |
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| p-value | 0.6246 |
| Least Square Mean Difference | -6.25 (95% CI -31.26–18.77) |
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