Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK2585823(CLDM 1%-BPO 3% gel)
GSK2585823 · 3 trials · 1 indication
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Blood PK sampling time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9,12hours post-dose (Day 1 and Day 8). Parameters: Maximum observed concentration(Cmax),Time of occurrence of Cmax (tmax), Area under the concentration-time curve from time zero (pre-dose) extrapolated to last time (AUC0-last), Area under the concentration-time curve from time zero (pre-dose) to 12 hours of quantifiable concentration within a subject across all treatments (AUC0-12) and Terminal phase half-life (t1/2,) for both benzoic acid and hippuric acid, after multiple application of GSK2585823, if calculable
| Arm | Type | Description |
|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) once daily | EXPERIMENTAL | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. |
| GSK2585823(CLDM 1%-BPO 3% gel) twice daily | EXPERIMENTAL | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. |
| CLDM 1% gel twice daily | ACTIVE_COMPARATOR | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. |
| GSK2585823 | EXPERIMENTAL | External Preparation |
| Benzoic peroxide 3% | ACTIVE_COMPARATOR | external preparation |
| Benzoic peroxide 5% | ACTIVE_COMPARATOR | external preparation |
| Vehicle | PLACEBO_COMPARATOR | external preparation |
| Name | Type | Description |
|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) | DRUG | Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg |
| CLDM 1% gel twice daily | DRUG | Topical gel containing clindamycin 10 mg/1 g gel |
| GSK2585823 | DRUG | CLDM1%/BPO3% |
| Benzoyl peroxide 3% | DRUG | Benzoyl peroxide 3% |
| Benzoyl peroxide 5% | DRUG | Benzoyl peroxide 5% |
| Vehicle | OTHER | placebo |
Inclusion Criteria: * Male or female subjects 12 to 45 years (inclusive) of age in good general health. * Subjects must have both on the face: A) A minimum of 17 but not more than 60 inflammatory lesions (papules/pustules), including nasal lesions. And B) A minimum of 20 but not more than 150 non...
GSK2585823 is being developed for the treatment of acne vulgaris, a common inflammatory skin condition. It is a topical small molecule therapy applied as a gel. The clinical program has studied the drug in Japanese subjects with acne vulgaris, including a Phase 3 confirmation study and two Phase 1 pharmacokinetic studies.
GSK2585823 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three clinical trials of the compound, which were conducted in Japan. GSK plc is the sole developer identified for this topical acne vulgaris asset.
GSK2585823 has completed a Phase 3 clinical trial, making it the most advanced stage reached in its development program. The compound is investigational and has not been approved by the FDA. All three of its registered trials, one Phase 3 and two Phase 1 studies, are listed as completed.
GSK2585823 has been studied in three completed clinical trials. The Phase 3 study NCT01445301 enrolled 800 Japanese subjects with acne vulgaris. Phase 1 trials NCT01527123 and NCT01428466 enrolled 12 and 20 subjects respectively, evaluating pharmacokinetics and safety in Japanese participants.
Yes, GSK2585823(CLDM 1%-BPO 3% gel) is an alternative name for GSK2585823. The parenthetical describes the formulation as a gel containing clindamycin 1 percent and benzoyl peroxide 3 percent. Both names refer to the same topical acne vulgaris treatment candidate developed by GSK plc.
Across the three completed clinical trials, 832 subjects were enrolled in studies of GSK2585823. The Phase 3 trial NCT01445301 accounted for 800 of those participants, while the two Phase 1 pharmacokinetic studies enrolled 12 and 20 subjects. All trials were conducted in Japan.