A Study to Evaluate Safety and Efficacy of Toreforant (JNJ-38518168) in Participants With Moderate to Severe Plaque-type Psoriasis
- Conditions
- Moderate to severe plaque-type psoriasis.MedDRA version: 17.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-000277-12-PL
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
- Subject must be a man or woman =18 years of age.
- Subject must have a diagnosis of plaque-type psoriasis (with or without PsA) for at least 6 months before the first administration of study drug.
- Subject must have a PASI =12 at screening and at baseline.
- Subject must have an IGA =3 at screening and at baseline.
- Subject must have a BSA =10% at screening and at baseline.
At screening, the results of the following laboratory tests performed at the central laboratory must be within the limits specified below. Note: except for ferritin, the investigator may consider the subject eligible if the previously abnormal laboratory test result is within normal range on a repeat testing in the central laboratory. Only 1 repeat testing is allowed. No repeat testing for ferritin is allowed.
a. Serum alanine aminotransferase levels (ALT): =1.5 x upper limit of normal (ULN)
b. Total bilirubin level: =1.5 x ULN
c. Hemoglobin: =10 g/dL (International System of Units [SI]: =100 g/L)
d. WBC: =3.0 x 103 cells/mm3 (SI: =3.0 x109 cells/L)
e. Platelets: =100 x 103 cells/mm3 (SI: =100 x 109 cells/L)
f. Neutrophils: =1.5 x 103 cells/mm3 (SI: =1.5 x 109 cells/L)
g. Ferritin: =500 ng/mL (SI: =500 µg/L)
If the results of clinical laboratory tests (including serum chemistry, hematology, and urinalysis) other than those specified above are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
Subject must be otherwise healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the subject's source documents and initialed by the investigator.
- Subject must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.
- Before randomization, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/L); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence. Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth contro
Any potential subject who meets any of the following criteria:
- Subject has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- Subject has a current malignancy or history of malignancy within 5 years before screening.
- Subject has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
- Subject has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers.
- Subject has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
- Subject has a transplanted organ
- Subject is infected with human immunodeficiency virus (HIV); positive serology for HIV antibody as confirmed by Western blot.
- Subject tests positive for acute or chronic hepatitis B virus (HBV) infection at the screening visit or has screening serology consistent with hepatitis C infection (seropositive for antibodies to hepatitis C virus (HCV), unless they have a negative HCV RNA test result within 6 months prior to the screening visit and have a second negative HCV RNA test result at the screening visit.
- Subject has a personal or familial history or risk of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS), including but not limited to, RA, systemic idiopathic juvenile arthritis (SiJA), or adult onset Still's disease (AOSD).
- Subject has moderate or severe renal insufficiency as measured by creatinine clearance (CrCL) less than 50 mL/min as calculated by Cockcroft-Gault formula: CrCL = (140 minus age) x ideal body weight (in kg) x 0.85 (if, female)/72 x serum creatinine (in mg/dL).
- Subject has a QTcF interval >450 msec at either the screening visit or Day 1/Week 0, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes.
- Subject has received drugs with a risk of torsades de pointes within 2 weeks or within 5 half-lives of the drug, whichever is longer, prior to the first administration of study drug.
- Subject has received drugs that are moderate/strong inducers or inhibitors of CYP3A4 or drugs that are inducers or inhibitors of Pgp within 2 weeks or within 5 half-lives of the drug, whichever is longer, prior to the first dose of study medication.
- Subject has received drugs that are substrates of CYP2C8 , any drugsthat are substrates of hOCT2 (except cimetidine, famotidine, and ranitidine), or any drugs that are substrates of CYP3A with narrow therapeutic range within 2 weeks or within 5 half-lives of the drug, whichever is longer, prior to the first dose of study medication.
- Subject has a nonplaque form of psoriasis.
- Subject has current drug-induced psoriasis
- Subject has ever received any previous biologic therapy for psoriasis or psoriatic arthritis.
- Subject has received any biolo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of JNJ-38518168 in subjects with moderate to severe plaque-type psoriasis.<br>To assess the safety and tolerability of JNJ-38518168 in subjects with moderate to severe plaque-type psoriasis.;Secondary Objective: To assess the impact of treatment with JNJ-38518168 on selected biomarkers.<br>To characterize the population pharmacokinetics of JNJ-38518168 in subjects with psoriasis.<br>To evaluate the relationship between exposure to JNJ-38518168 and appropriate efficacy/safety outcomes (eg, Psoriasis Activity Severity Index [PASI] 75).;Primary end point(s): The primary endpoint is the proportion of subjects who achieve a PASI 75 response at Week 12.;Timepoint(s) of evaluation of this end point: The primary endpoint is the proportion of subjects who achieve a PASI 75 response at Week 12.
- Secondary Outcome Measures
Name Time Method