Clinical trial NCT02209753 (phase 2, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: birb 796 bs, low dose, birb 796 bs, medium dose 1, birb 796 bs, medium dose 2, birb 796 bs, high dose, placebo
SMILES: CC1=CC=C(C=C1)N1N=C(C=C1NC(=O)NC1=CC=C(OCCN2CCOCC2)C2=C1C=CC=C2)C(C)(C)C, CC1=CC=C(C=C1)N1N=C(C=C1NC(=O)NC1=CC=C(OCCN2CCOCC2)C2=C1C=CC=C2)C(C)(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stable moderate to severe plaque-type psoriasis involving ≥5% body
             surface area

          -  History of plaque psoriasis for a minimum of 6 months prior to screening

          -  Age 18 - 75

          -  Males or females, females must be of non-childbearing potential (6 months
             post-menopausal, surgically sterilized) or using an approved form of birth control
             (oral contraceptives, Norplant®, Depo-Provera®, intrauterine device (IUD),
             double-barrier) and have a negative serum pregnancy test upon screening (Visit 1) and
             a negative urine test prior to randomization (Visit 2) into the trial

          -  Give informed consent and sign an approved consent form prior to any study procedures,
             including washout of prohibited medications

        Exclusion Criteria:

          -  Primary guttate, erythrodermic, or pustular psoriasis

          -  Psoriasis which has failed to improve significantly with systemic treatments such as
             cyclosporine or methotrexate. Patients resistant to one, but have had a documented
             response to another may be included with approval of the medical monitor. Treatment
             failure will not include failure to improve if a full course of treatment was unable
             to be completed due to adverse events, intolerance of the treatment or administrative
             reasons

          -  Patients who have experienced treatment failure with a TNF-blocking agent. Treatment
             failure is defined as not achieving at least a 40% reduction in PASI score or having
             the TNF-blocking agent discontinued due to lack of efficacy

          -  Patients unable to wash out of all current psoriasis treatments (systemic, topical and
             phototherapy) except emollients and shampoos prior to beginning trial medication

          -  Patients taking the following medications known to elevate liver enzymes who have not
             been taking these medications at a stable dose for at least 1 month (3 months for
             diclofenac) without changes to liver functions tests (LFTs) prior to randomization
             (Visit 2): estrogens, oral contraceptives, selective serotonin reuptake inhibitors
             (SSRIs), nonsteroidal anti-inflammatory drugs (NSAIDs), acetominophen ≤3 g/day,
             aspirin, vitamin supplements (at recommended daily allowance doses). Patients taking
             doses of acetaminophen greater than three grams per day are excluded. Any other
             medication known to elevate hepatic enzymes not listed above is excluded

          -  Patients using any of the medications listed in the protocol, without the appropriate
             washout period

          -  Patients with clinically significant abnormal baseline hematology, blood chemistry or
             urinalysis if the abnormality defines a disease listed as an exclusion criterion. All
             patients with a serum glutamate oxaloacetate transaminase, serum glutamate pyruvate
             transaminase , alkaline phosphatase greater than 1.5 x upper limit of normal (ULN) or
             total bilirubin greater than 1.0 x ULN will be excluded regardless of the clinical
             condition. Patients with serum creatinine, white blood cell (WBC) count, amylase,
             lipase, prothrombin time (PT), partial thromboplastin time (PTT), D-dimer, fibrin
             degradation product (FDP) greater than 1.5 x ULN, or blood smear poikilocytes or
             schistocytes greater than 1.0 x ULN will also be excluded. Patients with
             hemoglobinuria or proteinuria greater than 1+ will be excluded. Hemoglobinuria must be
             confirmed as hematuria with finding of red blood cell (RBC) on microscopic
             examination. Hematuria in a menstruating female will not require exclusion but must be
             repeated after menses has cleared prior to entry. Repeat laboratory testing is allowed
             once at screening prior to excluding the patient, to avoid excluding patients with
             transient or erroneous abnormal laboratory values

          -  Any clinically significant psychiatric illness which may interfere with the patient's
             participation in the trial or ability to interpret the trial results

          -  History of cardiovascular, renal, neurologic, liver, immunologic or endocrine
             dysfunction if they are clinically significant. A clinically significant disease is
             defined as one which in the opinion of the investigator may either put the patient at
             risk because of participation in the study or a disease which may influence the
             results of the study or the patient's ability to participate in the study

          -  Patients with any history of heart failure, patients with a recent history (i.e., 1
             year or less) of myocardial infarction or patients with any arrhythmia requiring drug
             therapy

          -  Any ECG value outside of the reference range of clinical relevance including, but not
             limited to, QTcB >480 ms, PR interval >240 ms, QRS interval >110 ms

          -  History of malignancy in the past 5 years except treated cutaneous squamous cell or
             basal cell carcinoma

          -  Any active immunodeficiency or active infection, or any serious infection (requiring
             hospitalization or IV/intramuscular antibiotics) in the past 3 months prior to
             screening. Patients testing positive to human immunodeficiency virus (HIV), hepatitis
             B or hepatitis C will be excluded

          -  History of prior tuberculosis infection or active tuberculosis, patients must have a
             negative skin test or chest x-ray within the past 6 months prior to screening (Visit
             1)

          -  History of drug or alcohol abuse within the past 2 years, active drug or alcohol
             abuse, or patients who consume more than three alcoholic drinks per day

          -  Patients who have taken an investigational drug within one month (30 days) or six half
             lives (whichever is greater) prior to screening (Visit 1). Patients who have been
             treated with any investigational antibody or other biological agent within the past 3
             months are excluded