Moderate to Severe Chronic Plaque Psoriasis MedDRA version: 14.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Other descriptive name: MT-1303
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 18 to 65 years (limits included) of age at the time of signing the informed consent form. 2. Able to provide written informed consent and to comply with the requirements of the protocol. 3. Have been diagnosed with plaque psoriasis for at least 6 months prior to screening. 4. Have moderate to severe chronic plaque psoriasis as defined by PASI score = 12 and BSA = 10% at baseline. 5. In the investigator's opinion is a candidate for systemic therapy. 6. For male and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method. All males who have not been sterilised (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) and females who do not meet the criteria for non child bearing potential are considered to have reproductive potential. For females, non-child-bearing potential is defined as either at least 2 years post-menopausal or permanently sterilised, e.g., by bilateral tubal occlusion, hysterectomy or bilateral salpingectomy. 7. Presence of antibodies (immunoglobulin G [IgG]) to Varicella Zoster Virus (VZV). 8. Negative results for both QuantiFERON-TB Gold test and chest X-ray (with no evidence of tuberculosis [TB]) at screening. Note: if the chest X-ray has been done in the past 6 months prior to screening, no repeat is necessary. Urine pregnancy test to be obtained and results negative prior to chest X ray. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular) 2.Current drug-induced or aggravated psoriasis 3.Pregnancy, lactation or a positive serum beta human chorionic gonadotropin (hCG) level measured during screening or at baseline, or intention to become pregnant or to breast-feed during the course of the study 4.History of cardiovascular diseases as stated in the protocol 5.Known high risk for QT/QTc prolongation such as a family history of long QT syndrome or sudden death 6.Low heart rate (< 50 bpm) at screening or baseline (measured using 12-lead electrocardiogram [ECG]) 7.History or known presence of cerebrovascular diseases or ischaemia of the spinal cord 8.Significant, uncontrolled disease such as respiratory (including chronic, obstructive pulmonary disease), renal, hepatic, endocrine and gastrointestinal disease 9.Subjects who are currently treated for autoimmune disorders other than psoriasis 10.History of cancer, in the last 5 years, including both solid tumour and haematological malignancies, but excluding basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved 11.Known active bacterial, viral, fungal or mycobacterial infection or any major episode of infection requiring hospitalisation or treatment with intravenous antibiotics within 28 days prior to randomisation or oral antibiotics within 14 days prior to randomisation 12.Known history of recurrent or chronic infection such as TB, hepatitis B, hepatitis C, human immunodeficiency virus or syphilis 13.Any documented history or diagnosis of diabetes mellitus (Type I or II) 14.Any significant eye disorder such as macular oedema, uveitis or evolutive retinopathy 15.History of, or currently active, primary or secondary immunodeficiency 16.Documented organ transplantation 17.History of alcohol abuse within 5 years prior to screening and any history of solvent and/or drug abuse 18.Previous exposure to fingolimod or to any other S1P receptor modulator (investigational products) 19.Known history of allergy, hypersensitivity or any serious reaction to any component of the study medication (i.e., mannitol, gelatine) 20.Previous treatment with any investigational agent within 3 months prior to randomisation or five half-lives of the investigational product, whichever is the longer 21.Receipt of a live vaccine within 28 days prior to randomisation 22.Have received systemic immunosuppressive agents (e.g., Tacrolimus) within 4 weeks prior to randomisation 23.Have received disease modifying anti-rheumatic drugs (DMARDs) within 4 weeks prior to randomisation 24.Topical therapy that could, in the opinion of the Investigator, affect psoriasis or PASI evaluation within 2 weeks prior to randomisation 25.Any systemic medications or treatments (other than biologics) that affect psoriasis or PASI evaluation including, but not limited to, oral or injectable corticosteroids, psoralens, sulfasalazine, hydroxyurea, fumaric acid esters derivatives within 4 weeks prior to randomisation 26.Systemic retinoids, 1,25 dihydroxy vitamin D3 and analogues at doses that might, in the opinion of the Investigator, affect psoriasis and PASI evaluation within 4 weeks prior to randomisation. However, vitamin/multivitamin supplements taken at doses at or around the recommended daily dose (RDA) are allowed 27.Have used phototherapy within 4 weeks prior to randomisation 28.Have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe chronic plaque psoriasis. To evaluate the efficacy of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI). ;Secondary Objective: To evaluate the efficacy of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo on clinical outcomes (Static Physician Global Assessment [PGA], body surface area [BSA], Nail Psoriasis Severity Index [NAPSI]). To evaluate the efficacy of MT-1303 on quality of life as measured by Dermatology Life Quality Index (DLQI). To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of MT-1303 and its active phosphorylated metabolite (MT 1303-P). ;Primary end point(s): Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) at Week 16.;Timepoint(s) of evaluation of this end point: Day -28 to -1 (Screening), Day1, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Proportion of subjects who achieve PASI 90 (at least 90% reduction from baseline in PASI score) at Weeks 4, 8, 12 and 16. • Proportion of subjects who achieve PASI 50 (at least 50% reduction from baseline in PASI score) at Weeks 4, 8, 12 and 16. • Proportion of subjects who achieve PASI 75 at Weeks 4, 8 and 12. • Mean percent change from baseline in PASI score at Weeks 4, 8, 12 and 16. • Mean percent change from baseline in Static PGA at Weeks 4, 8, 12 and 16. • Mean percent change from baseline in NAPSI score of the worst affected fingernail at Week 16. • Quality of life as measured by DLQI at Weeks 4, 8, 12 and 16. ;Timepoint(s) of evaluation of this end point: Various time points throughout the study - please refer to the detailed 'Time and Events Schedule' table in the protocol for full details. | — |
Countries
Bulgaria, Estonia, Germany, Hungary, Latvia, Poland, Russian Federation, Ukraine
Contacts
Public ContactPharmaceutical and Reg. Affairs
Mitsubishi Pharma Europe Ltd. (MPE)
Outcome results
None listed