GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

NCT ID: NCT03202004

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-09-28

Brief 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.

Conditions

Psoriasis

Keywords

PGA; efficacy; PASI; GSK2894512; NRS; Topical; psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GSK2894512 1% cream group

Subjects will apply a thin layer of GSK2894512 1% (10 milligrams per gram \[mg/g\]) topical cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.

Group Type: EXPERIMENTAL

GSK2894512 1% cream

Intervention Type: DRUG

1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.

Vehicle cream group

Subjects will apply a thin layer of vehicle cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.

Group Type: PLACEBO_COMPARATOR

Vehicle cream

Intervention Type: DRUG

Vehicle cream will be provided in tubes labeled in compliance with country requirements.

Interventions

GSK2894512 1% cream

1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.

Intervention Type: DRUG

Vehicle cream

Vehicle cream will be provided in tubes labeled in compliance with country requirements.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

ERT: Clinical Trial Technology Solutions

OTHER

Sponsor Role: collaborator

Q2 Solutions

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

200852

Identifier Type: -

Identifier Source: org_study_id