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Calcipotriol

Phase 1

Psoriasis | Small molecule | Dermatology |GSK plc|Last Updated: Nov 13, 2017

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2006

Target and mechanism

Molecular targetPTHLH
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Calcipotriol · 1 trial · 1 indication

Phase 1 1
NCT00358384Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034Psoriasis
COMPLETED10 Analytics
PHASE1COMPLETED
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation
Up to 8 weeks

Secondary Endpoints

Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing
Up to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving treatment AEXPERIMENTALEligible subjects will receive 0.1 percent pazopanib ointment.
Subjects receiving treatment BEXPERIMENTALEligible subjects will receive 0.5 percent pazopanib ointment.
Subjects receiving treatment CEXPERIMENTALEligible subjects will receive 1 percent pazopanib ointment.
Subjects receiving treatment DPLACEBO_COMPARATOREligible subjects will receive pazopanib vehicle as negative control.
Subjects receiving treatment EPLACEBO_COMPARATOREligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control.
Subjects receiving treatment FPLACEBO_COMPARATOREligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control.

Interventions

NameTypeDescription
PazopanibDRUGPazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
Pazopanib vehicleDRUGPazopanib vehicle will be given to subjects.
Betamethasone valerateDRUGBetamethasone valerate ointment with 0.1 percent concentration will be given to subjects.
CalcipotriolDRUGCalcipotriol ointment with 0.005 percent concentration will be given to subjects.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Stable (2-3 months) chronic plaque psoriasis covering greater than 5% body surface area (as determined by PASI palm method). * Other than having chronic plaque psoriasis, subject is health and ambulatory. * Women will be eligible to enter the study if they are of non-child-bea...

Countries:France
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Frequently asked questions about Calcipotriol

What is calcipotriol?

Calcipotriol is a small molecule being developed by GSK plc under the ticker GSK for psoriasis, a dermatology condition. It is in Phase 1 clinical development. The compound is also catalogued under the ChEMBL identifier CHEMBL2109562.

What is calcipotriol used for in psoriasis?

Calcipotriol is being studied for the treatment of psoriasis, specifically chronic plaque psoriasis. The single registered trial enrolled adults aged 18 years and older with the condition. It is investigational and has not been established as a marketed treatment for psoriasis.

What does calcipotriol target?

Calcipotriol targets PTHLH and acts as an inhibitor of that target. This mechanism underlies its development as a small molecule therapeutic for psoriasis. The target class is inhibitor, and the drug is not biomarker selected in the trial conducted to date.

Who is developing calcipotriol?

GSK plc, which trades under the ticker GSK, is the developer of calcipotriol. The company is responsible for the clinical program in psoriasis, a dermatology indication. The asset is a small molecule in Phase 1 development.

What phase is calcipotriol in?

Calcipotriol is in Phase 1 clinical development. It is investigational and is not approved for marketing. One Phase 1 trial has been completed, and no active trials are currently listed for the program.

What clinical trials is calcipotriol in?

Calcipotriol has been evaluated in one completed Phase 1 trial, NCT00358384, titled Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034. The trial enrolled 10 participants in France, was randomized and placebo controlled, and included adults aged 18 years and older of all sexes.