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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 for the treatment of plaque psoriasis and atopic dermatitis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
The molecular target of GSK2894512 1% has not been disclosed in available information. It is a small molecule topical cream being studied for its effects on inflammatory skin conditions, but its specific mechanism of action is not publicly detailed.
GSK2894512 1% is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK.
GSK2894512 1% is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in plaque psoriasis and one in atopic dermatitis. The drug remains investigational and has not received FDA approval.
GSK2894512 1% has been studied in two completed Phase 2 trials. NCT02564042 evaluated the cream in 227 adults with plaque psoriasis, and NCT02564055 evaluated it in 247 subjects aged 12 and older with atopic dermatitis. Both trials were conducted in the United States, Canada, and Japan.
GSK2894512 1% is a distinct investigational compound with no alternative names provided. It is being studied specifically for plaque psoriasis and atopic dermatitis, and its development program is separate from other marketed psoriasis therapies.