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ZK 245186

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Bayer AG|Last Updated: Jun 7, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment327

FDA Designations

No designations recorded

Clinical trial landscape

ZK 245186 · 2 trials · 1 indication

Phase 2 2
NCT01228513Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)Atopic Dermatitis
COMPLETED263 Analytics
NCT00944632Dose Escalation of Different Concentrations of ZK 245186 in Atopic DermatitisAtopic Dermatitis
COMPLETED64 Analytics
PHASE2COMPLETED
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Eczema Area and Severity Index (EASI)
At baseline

Eczema area and severity index

EASI
Measured after one week of treatment

Ezcema area and severity index

Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
up to 4 weeks

Secondary Endpoints

Subjects' assessment of pruritus
Measured at baseline
Subject's assessment of pruritus
Measured after one week of treatment
Investigator's Global Assessment of target area
up to 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.01% ointmentACTIVE_COMPARATORLowest concentration
0.03% ointmentACTIVE_COMPARATORMiddle concentration
0.1% ointmentACTIVE_COMPARATORHighest concentration
Placebo (vehicle without active)PLACEBO_COMPARATORNo active ingredient
Zk 245186 0.01% ointmentACTIVE_COMPARATORActive treatment, lowest dose
ZK 245186 0.03% ointmentACTIVE_COMPARATORActive comparator middle dose
ZK 245186 0.1% ointmentACTIVE_COMPARATORActive comparator highest dose
Vehicle ointmentPLACEBO_COMPARATORPlacebo comparator

Interventions

NameTypeDescription
ZK245186DRUGDaily topical application
Placebo (vehicle without active ingredient)DRUGDaily topical application
ZK 245186DRUGOnce daily topical non-occlusive application for up to 4 weeks
Placebo (vehicle ointment)DRUGOnce daily topical non-occlusive application for up to 4 weeks
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria * Body surface area affected by atopic dermatitis at or less than 15% at start of treatment Exclusion Criteria: * Pregnancy and breast-feeding * Conditions that may pose a threat to the patient or effect ...

Countries:United StatesJapanSouth Africa
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Frequently asked questions about ZK 245186

What is ZK 245186 used for?

ZK 245186 is an investigational small molecule being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its efficacy and safety in adult patients with this condition.

Who makes ZK 245186?

ZK 245186 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the drug's safety and efficacy in treating atopic dermatitis. The company's stock is traded under the ticker symbol BAYRY on the over-the-counter market.

What phase is ZK 245186 in?

ZK 245186 is currently in Phase 2 clinical development. It has completed two Phase 2 trials, with a total of 327 participants enrolled. The drug is still investigational and has not received FDA approval. Further studies would be needed to establish its safety and efficacy before any regulatory submission.

What clinical trials has ZK 245186 been in?

ZK 245186 has been evaluated in two completed Phase 2 clinical trials. The first, NCT00944632, enrolled 64 participants in South Africa and studied dose escalation of different concentrations. The second, NCT01228513, enrolled 263 participants in the United States and Japan to assess efficacy and safety of various concentrations.

How does ZK 245186 work?

ZK 245186 is a small molecule developed for topical application in atopic dermatitis. Its specific molecular target has not been disclosed in available information. The drug is being studied for its ability to treat the condition, but the precise mechanism of action is not publicly detailed.