Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
U0267 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| U0267 Foam | EXPERIMENTAL | U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. |
| Vehicle foam | PLACEBO_COMPARATOR | Vehicle 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. |
| Name | Type | Description |
|---|---|---|
| U0267 | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
| Vehicle | DRUG | All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). |
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...
U0267 is an investigational small molecule being developed for the treatment of plaque-type psoriasis. It is intended for use in patients with this skin condition, which is a form of psoriasis characterized by raised, inflamed patches of skin.
U0267 is being developed by GSK plc, a global biopharmaceutical company. GSK's stock is traded under the ticker symbol GSK on major stock exchanges.
U0267 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. However, it remains investigational and has not been approved by regulatory authorities.
U0267 has been studied in a Phase 3 clinical trial with the identifier NCT00688519. This trial, titled 'Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies,' was completed in the United States and enrolled 336 participants aged 12 years and older.
U0267 is a small molecule, but its specific molecular target has not been disclosed. As a result, the exact mechanism of action for U0267 in treating psoriasis is not publicly known.