A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis

Status Completed

Clinical Trial Summary

This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Psoriasis

Clinical Trial Details

NCT number	NCT02564042
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 2
Start date	November 23, 2015
Completion date	October 5, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03236870` - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed	`NCT00078819` - Etanercept (Enbrel®) in Psoriasis - Pediatrics	Phase 3
Completed	`NCT04841187` - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting	`NCT03927352` - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis	Phase 3
Completed	`NCT03284879` - Post-Marketing Surveillance Study of OTEZLA
Recruiting	`NCT06027034` - Effectiveness of a Digital Health Application for Psoriasis	N/A
Not yet recruiting	`NCT06050330` - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study	N/A
Recruiting	`NCT05744466` - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed	`NCT04149587` - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed	`NCT01384630` - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis	Phase 2
Completed	`NCT03998683` - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis	Phase 3
Terminated	`NCT03556202` - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)	Phase 3
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06077331` - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis	Phase 2
Completed	`NCT04316585` - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants	Phase 1
Completed	`NCT04894890` - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed	`NCT00358384` - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034	Phase 1
Completed	`NCT03757013` - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed	`NCT03265613` - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis	Phase 1/Phase 2
Completed	`NCT05003531` - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis	Phase 2