gsk2894512 vehicle-controlled study for adult plaque psoriasis

Conditions: Psoriasis

Summary: this study will evaluate the efficacy and safety of gsk2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. this is a randomized, double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis. the aim of this study is to show superiority of gsk2894512 over vehicle by comparing their response rates. the study will consist of 3 periods: up to 4 weeks screening, 12 weeks blinded treatment, and 1 week post-treatment follow-up period. subjects will apply randomized study treatment to all psoriasis lesions once daily for 12 weeks. subjects will be stratified by baseline physician global assessment (pga) category (pga score=2, pga score \>=3) at randomization. approximately 120 subjects will be randomized into the study of which 80 will receive gsk2894512 1% cream and 40 will receive vehicle cream. total duration of a subject's participation in the study will be approximately for 14 to 17 weeks.


Eligibility criteria:
inclusion criteria: * age \>=18 years at the time of signing the informed consent. * clinical diagnosis of chronic stable plaque psoriasis. diagnosis and chronicity to be confirmed and documented by an experienced dermatologist. * body surface area involvement \>=2%. * a pga score of \>=2. * one target plaque located on the trunk or extremities that is at least 9 centimeter (cm)\^2 in size with a target plaque severity score (tpss) \>=5 and an induration sub score \>=2. primary target plaque should not be located on the knees, elbows, feet, ankle, hands, intertriginous areas, face, or scalp.) * male or female. a female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * not a woman of childbearing potential (wocbp), or * is a wocbp who agrees to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 1 week after the last exposure to study treatment. * capable of giving signed informed consent exclusion criteria: * psoriasis other than plaque variant. * any sign of infection of any of the psoriatic lesions. * concurrent conditions and history of other diseases: * immunocompromised (examples: lymphoma, acquired immunodeficiency syndrome) or have a history of malignant disease within 5 years before the baseline visit. * chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit. * active acute bacterial, fungal, or viral (examples: herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit * significant dermatologic or inflammatory condition other than plaque psoriasis that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study. * a history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study. * known hypersensitivity to gsk2894512 or excipients of the study treatments, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation. * alanine transferase (alt) \>2 times upper limit of normal (uln). * bilirubin \>1.5 times uln (isolated bilirubin \>1.5 times uln is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * stable chronic liver disease (including gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis b or c, examples: presence of hepatitis b surface antigen \[hbsag\] or positive hepatitis c antibody test result at screening or within 3 months prior to starting study treatment) is acceptable if the subject otherwise meets entry criteria. * qt interval corrected for heart rate according to fridericia's formula qtcf \>450 milliseconds (msec) or qtcf \>480 msec in subjects with bundle branch block. * ultraviolet (uv) light therapy or prolonged exposure to natural or artificial sources of uv radiation (examples: phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which could potentially impact the subject's psoriasis (as determined by the investigator). * used any of the following treatments within the indicated period before the baseline visit: * minimum of 5 half-lives for biologic agents -12 months: rituximab or efalizumab; 8 months: ustekinumab; 5 months: secukinumab; 12 weeks: golimumab; 10 weeks: ixekizumab; 8 weeks: infliximab, adalimumab, or alefacept; 4 weeks: etanercept (list is not exclusive, contact medical monitor for questions). * 4 weeks -systemic treatments: cyclosporin, interferon, methotrexate, apremilast, tofacitinib, mycophenolate, thioguanine, hydroxyurea, sirolimus, azathioprine, other systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin d3 and analogs, retinoids (examples: acitretin, isotretinoin), psoralens, corticosteroids, or adrenocorticotropic hormone analogs. * 2 weeks -immunizations; drugs known to possibly worsen psoriasis, such as beta-blockers (example, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for \>12 weeks. * 2 weeks -topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), vitamin d derivatives (examples: calcipotriene, calcipotriol), retinoids (example, tazarotene), or coal tar (used on the body). * participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). * participated in a previous study using gsk2894512 or wbi-1001.

Keywords: pga efficacy pasi gsk2894512 nrs topical psoriasis