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Also known as GSK2894512 1% Cream
GSK2894512 1% · 2 trials · 2 indications
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants.
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.
| Arm | Type | Description |
|---|---|---|
| GSK2894512 1% cream twice daily | EXPERIMENTAL | Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram \[mg/g\]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| GSK2894512 1% cream once daily | EXPERIMENTAL | Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| GSK2894512 0.5% cream twice daily | EXPERIMENTAL | Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| GSK2894512 0.5% cream once daily | EXPERIMENTAL | Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| Vehicle cream twice daily | PLACEBO_COMPARATOR | Subjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| Vehicle cream once daily | PLACEBO_COMPARATOR | Subjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp). |
| Name | Type | Description |
|---|---|---|
| GSK2894512 1% Cream | DRUG | 1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically |
| GSK2894512 0.5% Cream | DRUG | 0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically |
| Vehicle cream | DRUG | White to off-white vehicle cream base to be applied topically |
Inclusion Criteria: * Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent * Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation. * Body surface area involvement \>=5% and \<=35%, excluding scalp, at S...
GSK2894512 1% is an investigational small molecule cream being developed by GSK plc for inflammatory skin conditions. It is a topical formulation studied in atopic dermatitis and plaque psoriasis. It has completed Phase 2 clinical development and is not approved for commercial use.
GSK2894512 1% was studied for the treatment of atopic dermatitis and plaque psoriasis, two inflammatory skin conditions. Phase 2 trials evaluated the cream in adults and adolescents with these conditions. It remains an investigational therapy and is not approved for any indication.
GSK2894512 1% is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. The company sponsored the Phase 2 clinical program evaluating the topical cream in atopic dermatitis and plaque psoriasis.
GSK2894512 1% has completed Phase 2 clinical development. Two Phase 2 dose-finding trials were conducted, one in atopic dermatitis and one in plaque psoriasis, and both are now completed. The drug is investigational and has not been approved by the FDA.
GSK2894512 1% was evaluated in two completed Phase 2 trials. NCT02564055 was a dose-finding study in atopic dermatitis enrolling 247 participants, and NCT02564042 was a dose-finding study in plaque psoriasis enrolling 227 participants. Both trials were randomized, double-blind, and placebo-controlled, and were conducted in the United States, Canada, and Japan.
Yes, GSK2894512 1% and GSK2894512 1% Cream refer to the same investigational product. The cream designation describes the topical formulation of the small molecule developed by GSK plc for atopic dermatitis and plaque psoriasis.