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ZK 245186

Phase 2

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

ZK 245186 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2009

ZK 245186 target and mechanism

ModalitySmall molecule

Also known as Mapracorat (BAY86-5319)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment327

FDA Designations

No designations recorded

ZK 245186 clinical trials

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 studied for the treatment of atopic dermatitis, a chronic inflammatory skin condition. It has been evaluated in Phase 2 clinical trials in adults with atopic dermatitis. It is not approved for any indication and remains in clinical development.

Who is developing ZK 245186?

ZK 245186 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical research conducted to date on this compound in atopic dermatitis.

What phase is ZK 245186 in?

ZK 245186 is in Phase 2 development. Two Phase 2 trials in atopic dermatitis have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials has ZK 245186 been studied in?

ZK 245186 has been studied in two completed Phase 2 trials in atopic dermatitis: NCT01228513, which enrolled 263 patients across the United States and Japan, and NCT00944632, a dose escalation study that enrolled 64 patients in South Africa. Both were randomized, double-blind, and placebo-controlled, with total enrollment of 327 adults.

Is ZK 245186 the same as ZK245186?

Yes, ZK 245186 and ZK245186 refer to the same investigational compound. The spelling without a space appears in the title of the dose escalation trial NCT00944632, while the spaced form is used in NCT01228513. Both names identify the same Bayer small molecule developed for atopic dermatitis.