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U0267 Foam

Phase 3

Psoriasis | Small molecule | Dermatology |GSK plc|Trials Updated: Oct 7, 2016

U0267 Foam development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment323

FDA Designations

No designations recorded

U0267 Foam clinical trials

U0267 Foam · 1 trial · 1 indication

Phase 3 1
NCT00689481Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 StudiesPsoriasis
COMPLETED323 Analytics
PHASE3COMPLETED
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment
8 weeks

Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.

Secondary Endpoints

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

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
U0267 foamEXPERIMENTALU0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle foamPLACEBO_COMPARATORVehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Interventions

NameTypeDescription
U0267 FoamDRUGAll treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
Vehicle foamDRUGAll treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Male or female subjects at least 12 years old and in good general health. * Mild to moderate plaque-type psoriasis Exclusion Criteria: * Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulatio...

Countries:United States
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Frequently asked questions about U0267 Foam

What is U0267 Foam used for?

U0267 Foam is an investigational small molecule therapy being developed for the treatment of psoriasis, specifically plaque-type psoriasis. It is formulated as a foam and is being studied in patients with this skin condition. GSK plc is developing the asset, which has reached Phase 3 clinical development.

Who makes U0267 Foam?

U0267 Foam is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the foam formulation in plaque-type psoriasis. The company holds the development rights for this dermatology asset.

What phase is U0267 Foam in?

U0267 Foam is in Phase 3 clinical development for plaque-type psoriasis. One Phase 3 trial has been completed, and no trials are currently listed as active. The asset remains investigational and has not been approved by the FDA for any indication.

What clinical trials is U0267 Foam in?

U0267 Foam has been evaluated in the Phase 3 trial NCT00689481, titled a study to compare U0267 against vehicle in subjects with plaque-type psoriasis. The trial enrolled 323 participants in the United States, was randomized, double-blind, and placebo-controlled, and has completed.

Is U0267 Foam FDA approved?

U0267 Foam is not approved and remains an investigational therapy in Phase 3 clinical development for plaque-type psoriasis. Its only listed trial, NCT00689481, has completed, and no active trials are currently recorded for the asset.