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Also known as Zabedosertib (BAY1834845)
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 not yet approved for any indication. The clinical program has focused on evaluating its potential in dermatology, specifically for patients with this chronic inflammatory skin condition.
Zabedosertib is being developed by Bayer AG, a multinational pharmaceutical and life sciences company. Bayer's U.S.-listed shares trade under the ticker BAYRY. The company has sponsored the clinical trial evaluating the drug in atopic dermatitis.
Zabedosertib is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for atopic dermatitis or any other condition.
Zabedosertib has been evaluated in one completed Phase 2 trial, NCT05656911. The study was a randomized, double-blind, placebo-controlled trial that enrolled 77 adults with moderate-to-severe atopic dermatitis across the United States, Czechia, France, Germany, Italy, Poland, and the United Kingdom.
Yes, Zabedosertib is also known as BAY1834845. BAY1834845 is the compound code used by Bayer during development, while Zabedosertib is the international nonproprietary name. Both names refer to the same investigational small molecule being studied in atopic dermatitis.