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U0267 Foam

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment323

FDA Designations

No designations recorded

Clinical trial landscape

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 in psoriasis?

U0267 Foam is an investigational small molecule being studied for the treatment of plaque-type psoriasis. It is a topical foam formulation developed by GSK plc. The drug is currently in Phase 3 clinical development, though the specific trial has been completed. It is not yet approved by regulatory authorities.

What does U0267 Foam target?

U0267 Foam is a small molecule developed for topical use in psoriasis. The specific molecular target of U0267 Foam has not been disclosed in available clinical trial information. The drug is being evaluated for its efficacy and safety in treating plaque-type psoriasis, a chronic inflammatory skin condition.

Who makes U0267 Foam?

U0267 Foam is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's potential as a treatment for plaque-type psoriasis.

What phase is U0267 Foam in?

U0267 Foam is in Phase 3 clinical development. A Phase 3 study, NCT00689481, has been completed. This trial was a randomized, double-blind, placebo-controlled study that enrolled 323 participants with plaque-type psoriasis. The drug remains investigational and has not received regulatory approval.

What clinical trials is U0267 Foam in?

U0267 Foam has one completed Phase 3 clinical trial, NCT00689481, titled 'Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies.' This randomized, double-blind, placebo-controlled study enrolled 323 participants in the United States, including individuals aged 12 years and older.

Is U0267 Foam the same as any other drug?

U0267 Foam is the name used in clinical trials for this investigational product. No alternative names have been disclosed in the available trial information. The drug is being studied specifically as a topical foam for plaque-type psoriasis and is not known to be marketed under any other name.