Recent Updates
Recently added Catalysts

Mapracorat

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Bayer AG|Last Updated: Oct 31, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment232

FDA Designations

No designations recorded

Clinical trial landscape

Mapracorat · 4 trials · 3 indications

Phase 2 3Phase 1 1
NCT01408511HPA Axis Study in AdultsAtopic Dermatitis
COMPLETED23 Analytics
NCT01407510HPA Axis Study in Japanese AdultsAtopic Dermatitis
COMPLETED12 Analytics
NCT01359787Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)Atopic Dermatitis
COMPLETED197 Analytics
PHASE2COMPLETED
HPA Axis Study in Adults
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
HPA Axis Study in Japanese Adults
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
measured after 4 weeks of therapy
number of subjects with adrenal suppression
Eczema Area and Severity Index (EASI)
Over all study visits for up to 4 weeks
Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound
Prior to drug application from Day 1 and up to Day 29

Assessment was done on the test fields on psoriatic plaques

Secondary Endpoints

Subjects´ assessment of pruritus
At baseline and after 4 weeks of treatment
Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement)
Prior to drug application from Day 1 up to Day 60
Clinical assessment of atrophy using a 5-point score
Prior to drug application from Day 1 and up to Day 29
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Mapracorat 0.01% OintmentACTIVE_COMPARATORLowest concentration
Mapracorat 0.03% OintmentACTIVE_COMPARATORMiddle concentration
Mapracorat 0.1% OintmentACTIVE_COMPARATORHighest concentration
Vehicle without activePLACEBO_COMPARATOR -
MapracoratEXPERIMENTAL10 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2
PrednicarbateACTIVE_COMPARATOR10 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2
ClobetasolACTIVE_COMPARATOR10 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2
CalcipotrieneACTIVE_COMPARATOR10 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2
Calcipotriene/Betamethasone dipropionateACTIVE_COMPARATOR10 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total \[diameter 2 cm, distance to next test field at least 2 cm\]). 200 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total \[diameter 1.8 cm, distance to next test field at least 1.5 cm\]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2

Interventions

NameTypeDescription
MapracoratDRUGApplication of the investigational product on the affected skin areas
Vehicle without activeDRUGDaily topical application
Mapracorat (ZK 245186, BAY 86-5319)DRUG0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
Prednicarbate 0.25% ointmentDRUG0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
Clobetasol 0.05% ointmentDRUG0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
Calcipotriene 0.005% ointmentDRUG0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointmentDRUG0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Signed written informed consent * Male or female subject aged \>= 18 years * Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria * Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline * Normal ACTH response before start of t...

Countries:South AfricaJapanGermany
Unlock Eligibility Criteria

Frequently asked questions about Mapracorat

What is Mapracorat used for?

Mapracorat is an investigational small molecule being developed for the treatment of atopic dermatitis (eczema) and psoriasis. It is applied as an ointment and has been studied in clinical trials for these dermatological conditions.

Who is developing Mapracorat?

Mapracorat is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market.

What phase is Mapracorat in?

Mapracorat is in Phase 2 clinical development. It has completed Phase 2 trials for atopic dermatitis and a Phase 1 trial for psoriasis. It is not yet approved by regulatory authorities and remains investigational.

What clinical trials has Mapracorat been in?

Mapracorat has been studied in several completed trials. NCT01359787 evaluated different concentrations of Mapracorat ointment over 4 weeks in atopic dermatitis. NCT01407510 and NCT01408511 were HPA axis studies in Japanese and general adults with atopic dermatitis. NCT03399526 was a Phase 1 psoriasis plaque test.

Is Mapracorat the same as any other drug?

Mapracorat is a distinct investigational compound. No alternative names have been reported in the clinical trial records. It is being studied under its own name for dermatological indications.