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Calcipotriene Foam

Phase 3

Psoriasis | Small molecule | Dermatology |GSK plc|Trials Updated: Jan 18, 2017

Calcipotriene Foam development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2001

Calcipotriene Foam target and mechanism

Molecular targetVDR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment363

FDA Designations

No designations recorded

Calcipotriene Foam clinical trials

Calcipotriene Foam · 1 trial · 1 indication

Phase 3 1
NCT01139580The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body PsoriasisPsoriasis
COMPLETED363 Analytics
PHASE3COMPLETED
The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
Week 8

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
Week 8

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Secondary Endpoints

Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
Baseline and Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Calcipotriene FoamEXPERIMENTALCalcipotriene Foam 0.005%,
Vehicle FoamPLACEBO_COMPARATORVehicle Foam

Interventions

NameTypeDescription
Calcipotriene FoamDRUGCalcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Vehicle FoamDRUGVehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. * Male or female subjects at least 12 years old and in good general...

Countries:United States
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Frequently asked questions about Calcipotriene Foam

What is calcipotriene foam used for?

Calcipotriene foam is used to treat psoriasis, including psoriasis affecting both the scalp and the body. It is a topical small molecule therapy being developed by GSK plc under the ticker GSK. The Phase 3 program evaluated it in subjects with scalp and body psoriasis.

How does calcipotriene foam work?

Calcipotriene foam works as an agonist of the vitamin D receptor, also known as VDR. By activating VDR, the small molecule modulates the biological pathways involved in psoriasis. This receptor agonist mechanism underlies its activity as a topical dermatology treatment.

Who makes calcipotriene foam?

Calcipotriene foam is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor behind the clinical development of this topical small molecule for psoriasis in the dermatology therapeutic area.

What phase is calcipotriene foam in?

Calcipotriene foam has reached Phase 3 clinical development. It is an investigational topical small molecule for psoriasis and is not described as approved. The Phase 3 trial has been completed, and no trials are currently listed as active.

What clinical trials is calcipotriene foam in?

Calcipotriene foam has been studied in the Phase 3 trial NCT01139580, titled a study to demonstrate the safety and effectiveness of calcipotriene foam in subjects with scalp and body psoriasis. It was a completed, randomized, double-blind, placebo-controlled trial that enrolled 363 participants in the United States.