Clinical trial NCT03004846 (phase 1/phase 2, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: gsk2981278 ointment, vehicle ointment
SMILES: CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and above, at the time of signing the informed consent.

          -  Subjects with clinical diagnosis of stable plaque psoriasis for more than or equal to
             6 months, as confirmed by the investigator.

          -  BSA involvement more than or equal to 5 percent and less than or equal to 15 percent,
             excluding face and intertriginous areas, at Screening and Baseline. The area of
             psoriasis involvement may include up to 2 percent of total BSA on the scalp with only
             sparse terminal hair and/or vellus hair.

          -  A PGA score of greater than or equal to 2 at Baseline.

          -  One target plaque located on the trunk or proximal parts of extremities (excluding
             scalp, knees, and elbows) that is at least 9 Centimeter ^2 in size at Screening and
             Baseline with a TPSS greater than or equal to 5 and induration sub score greater than
             or equal to 2.

          -  Male subjects with female partners of child bearing potential must comply with the
             following contraception requirements from the time of first dose of study medication
             until 2 weeks after the last dose of study medication: a) Vasectomy with documentation
             of azoospermia. The documentation on male sterility can come from the site
             personnel's: review of subject's medical records, medical examination and/or semen
             analysis, or medical history interview. B) Male condom. The allowed method of
             contraception is only effective when used consistently, correctly and in accordance
             with the product label. The investigator is responsible for ensuring that subjects
             understand how to properly use these methods of contraception.

          -  Female of non-reproductive potential (FNRP) is eligible to participate in this study
             if she meets at least one of the following conditions: a) Females with one of the
             following procedures documented and no plans to utilize assisted reproductive
             techniques (e.g., in vitro fertilization or donor embryo transfer): bilateral tubal
             ligation or salpingectomy, hysteroscopic tubal occlusion procedure with follow-up
             confirmation of bilateral tubal occlusion, hysterectomy, bilateral Oophorectomy
             (surgical menopause); b) Post-menopausal women including Females 60 years of age or
             older, A practical definition accepts menopause after 1 year without menses with an
             appropriate clinical profile, e.g., age appropriate, more than 45 years, in the
             absence of hormone replacement therapy (HRT) or medical suppression of the menstrual
             cycle (e.g., leuprolide treatment). In questionable cases for women less than 60 years
             of age, a blood sample with simultaneous follicle stimulating hormone and estradiol
             falling into the central laboratory's post-menopausal reference range is confirmatory
             (these levels need to be adjusted for specific laboratories/assays. Females fewer than
             60 years of age, who are on HRT and wish to continue, and whose menopausal status is
             in doubt, should not be enrolled in this study. Otherwise, they must discontinue HRT
             to allow confirmation of post-menopausal status prior to study enrolment. For most
             forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and
             the blood draw; this interval depends on the type and dosage of HRT. Following
             confirmation of their post-menopausal status, they can enroll into the study and
             resume use of HRT.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the consent form and in this protocol.

        Exclusion Criteria:

          -  Psoriasis other than plaque variant (i.e. acute psoriasis guttate, psoriasis punctata,
             psoriasis erythroderma or pustular psoriasis).

          -  Current evidence of another ongoing or any acute cutaneous infection, history of
             repeated or chronic significant skin infections (unless irrelevant in the opinion of
             the investigator, i.e. onychomycosis, labial herpes or other minor diagnosis).

          -  Clinically-relevant skin disease or other skin pathologies, that may, in the opinion
             of the investigator, contraindicate participation or interfere with skin evaluations.

          -  ALT more than 2x Upper limit of normal (ULN) and bilirubin more than 1.5x ULN
             (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and
             direct bilirubin less than 35 percent).

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  Corrected QT interval using Bazett's formula (QTcB) more than 450 milliseconds (msec)
             or QTcB more than 480 msec in subjects with Bundle Branch Block. The QTcB should be
             based on single QTcB values of ECG obtained over a brief recording period. If QTcB is
             outside the threshold value, triplicate ECGs may be performed with the QTcB values
             averaged.

          -  Any condition that, in the judgment of the investigator, would put the subject at
             un-acceptable risk for the participation in the trial.

          -  History of malignancy within 5 years prior to dosing, except adequately treated
             non-invasive cancer of the skin (basal or squamous cell).

          -  Use of prohibited concomitant medications or products within the defined periods
             before the Day 1 visit and during the trial

          -  History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy that, in the opinion of the investigator or Medical
             Monitor, contraindicates their participation.

          -  Symptoms of a clinically significant illness that may, in the opinion of the
             investigator, influence the outcome of the trial in the 4 weeks before baseline visit
             and during the trial.

          -  Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
             result at screening or within 3 months prior to first dose of study treatment.

          -  A positive pre-study drug/alcohol screen.

          -  A positive test for human immunodeficiency virus (HIV) antibody.

          -  For Part B only-the subject has participated in Part A of this study.

          -  The subject has participated in a clinical trial and has received an investigational
             product within the following time period prior to the first dosing day in the current
             study: 4 weeks, 5 half-lives or twice the duration of the biological effect of the
             investigational product (whichever is longer).

          -  Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation
             (e.g., exposure to sunlight other than that associated with usual daily activities,
             use of tanning booth, etc.) within 2 weeks prior to the Day 1 visit or intention to
             have such exposure during the study, thought by the investigator likely to modify the
             subject's psoriasis.

          -  In the opinion of the investigator or physician performing the initial examination the
             subject should not participate in the clinical trial, e.g. due to probable
             noncompliance, inability to understand the trial and give adequately informed consent,
             or inability to complete the Psoriasis Symptom Diary.

          -  Close affiliation with the investigator (e.g. a close relative) or persons working at
             bioskin GmbH or subject is an employee of sponsor.

          -  Subject is institutionalized because of legal or regulatory order.