Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zabedosertib · 1 trial · 1 indication
The endpoint was the composite variable defined as follows: - an EASI 75 response at Week 12 (Day 84), - no stop of study intervention for reasons related to lack of efficacy, - no rescue medication use during the 4 weeks before Day 84 and - no use of systemic atopic dermatitis (AD) treatment. The main estimand was the difference in the proportion of responders between treatment groups in adults with moderate-to-severe atopic dermatitis where use of topical rescue medication from Day 56 (Visit 6) onwards, use of systemic standard of care for AD and discontinuation of treatment due to lack of efficacy are handled as non-response (composite strategy). The estimand was regardless of use of rescue medication before Day 56 (Visit 6), regardless of non-compliance with emollients, and had treatment not been discontinued due to other reasons not related to lack of efficacy. Bayesian analysis according to estimand is presented.
| Arm | Type | Description |
|---|---|---|
| Zabedosertib | EXPERIMENTAL | Participants will receive zabedosertib for up to 12 weeks (84 days). |
| Matching placebo to zabedosertib | PLACEBO_COMPARATOR | Participants will receive placebo to zabedosertib for up to 12 weeks (84 days). |
| Name | Type | Description |
|---|---|---|
| Zabedosertib (BAY1834845) | DRUG | Oral administration, two times a day |
| Placebo to zabedosertib (BAY1834845) | DRUG | Oral administration, two times a day |
Inclusion Criteria: * 18 to 65 years of age inclusive, at the time of signing the informed consent. * Diagnosis of atopic dermatitis (AD) for ≥ 1 year at the screening visit. * Moderate-to-severe AD at randomization visit as defined by * Eczema Area and Severity Index (EASI) score ≥ 16, * Body...
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Zabedosertib is an investigational small molecule being studied for the treatment of moderate-to-severe atopic dermatitis in adults. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Zabedosertib is a small molecule developed by Bayer AG. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.
Zabedosertib is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical trials for atopic dermatitis.
Zabedosertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for the treatment of atopic dermatitis.
Zabedosertib has one completed Phase 2 trial, NCT05656911, which evaluated its efficacy and safety compared to placebo in 77 adult participants with moderate-to-severe atopic dermatitis. The trial was randomized, double-blind, and placebo-controlled.
Yes, Zabedosertib is also known as BAY1834845. The clinical trial NCT05656911 refers to the drug as Zabedosertib (BAY1834845), confirming that these names refer to the same investigational compound.