Clinical trial NCT03202004: GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis
Official title: A Double-Blind Safety and Efficacy Study of GSK2894512 Cream Versus Vehicle in the Treatment of Adult Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: PGA
efficacy
PASI
GSK2894512
NRS
Topical
psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: ERT: Clinical Trial Technology Solutions
name: Q2 Solutions
First posted: 2017-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
timeFrame: Baseline (Day 1) and up to Week 12
measure: Proportion OF SUBJECTS WITH>=3-POINT REDUCTION IN WEEKLY AVERAGE ITCH/PRURITUS NUMERIC RATING SCALE (NRS) FROM BASELINE TO WEEK 12 FOR SUBJECTS WITH A BASELINE SCORE >=4
timeFrame: Baseline (Day 1) and up to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: