A clinical study to investigate the effects of MT-1303 on patients with moderate to severe Chronic Plaque Psoriasis focusing on how safe, tolerable and effective in treating the above condition MT-1303 is.
- Conditions
- Moderate to Severe Chronic Plaque PsoriasisMedDRA version: 17.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-005750-27-EE
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation (MTPC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
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) at screening.
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 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method