Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: Dimethyl Fumarate Gastro-Resistant Hard Capsule of Alvogen Malta (Out-Licensing) Ltd: Hard Capsule of 30 mg & 120 mg.
Dosing will be started with a low initial dose with subsequent inc
Sponsors
Alvogen Malta OutLicensing Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female aged 18 years or older with clinical diagnosis of moderate to severe chronic plaque psoriasis. 2. Subject with a diagnosis of chronic plaque psoriasis for at least 12 months before enrolment in the study 3. Subject with general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results, and physical examination. 4. Subject with the prior therapy with systemic drugs for psoriasis or naÃ?¯ve to systemic treatment but identified as a candidate for systemic treatment. 5. Subject willing and able to take the assigned study medication as directed, comply with all study procedures, and commit to coming for the follow-up visits for the entire duration of the study 6. Adhering to the following washout periods prior to baseline/randomisation visit: ïÆ?¼ïâ?¬Â Topical treatments like Corticosteroids, Vitamin A analogues, Vitamin D analogues, Anthracene derivatives, Coal Tar, Salicylic acid preparations: 2 weeks or 5 half-lives (whichever is greater) ïÆ?¼ïâ?¬Â Systemic treatment biologics with antipsoriatic activity: 3 months or 5 half-lives (whichever is greater) ïÆ?¼ïâ?¬Â Conventional systemic antipsoriatic drugs and phototherapy: 1 month or 5 half-lives (whichever is greater) ïÆ?¼ïâ?¬Â Immunosuppressive medication (if not covered by any of the above treatments) & Cytostatics: 6 months or 5 half-lives (whichever is greater) ïÆ?¼ïâ?¬Â Medications with known harmful influences on the kidneys: (e.g. Methotrexate, Ciclosporin, Aminoglycosides, Diuretics) 5 x half-life 7. For females of childbearing potential: a negative serum pregnancy test at screening and willing to use acceptable effective methods of birth control during the treatment period and for 60 days after last dose of IMPs . 8. Male subject (except vasectomised) must be willing to use adequate methods of contraception (e.g barrier contraception) till the end of study. 9. Subject is willing and able to provide written informed consent prior to study. 10. Willing to keep sun exposure reasonably constant and not to use tanning booths or other UV light sources for the duration of the study. 11. Subject is willing and able to take the assigned study medication as directed, and comply with all the study procedures. 12. Subject with the severity of psoriasis defined as moderate to severe, as reflected in meeting all the following criteria: ïÆ?¼ïâ?¬Â PASI (Psoriasis Area and Severity Index) > 10 BSA (body surface area) > 10 % Physician Global Assessment (PGA) score (score of 3 equal to moderate, 4 equal to moderate to severe; or 5 equal to severe)
Exclusion criteria
Exclusion criteria: 1. Female who are breastfeeding, pregnant, or planning to become pregnant. 2. Subject with a diagnosis of non-plaque psoriasis (e.g. guttate, erythrodermic, or pustular psoriasis). 3. Subject with a haematological abnormality as follows: ïÆ?¼ïâ?¬Â Platelet count ïÆ?¼ïâ?¬Â WBC count ïÆ?¼ïâ?¬Â Lymphocyte count ïÆ?¼ïâ?¬Â Haemoglobin, haematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the lab. 4. Subject with a history of malignancies except for non-melanoma skin cancer. 5. Subject suffering from significant gastrointestinal problems (ulcers, diarrhoea, etc.). 6. Subject with known to have significant renal impairment. 7. Subject is detected to have abnormal AST, ALT, ALP and Gamma-glutamyl transferase > 2x the upper limit of the normal range. 8. Subject with active infectious disease. 9. Subject on systemic therapy with drugs that may interfere with the investigational products taken within the defined washout period. 10. Subject with a history of alcohol or drug abuse in past 1 year. 11. Subject with known HIV-positive status or suffering from any other immunosuppressive disease. 12. Subject with severe liver or kidney disease. 13. Subject known to be hypersensitive to ingredients of the investigational products. 14. Previous enrolled in this study or participating in any other drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment. 15. Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study. 16. Any live vaccination within 8 weeks prior to the baseline visit, or a live vaccination planned during the study. 17. Employee of the Investigator, CRO, sponsor who is involved in the study, or immediate family members (e.g., partner, offspring, parents, siblings or siblingââ?¬•s offspring) of an employee who is involved in the study. 18. Subject with difficulty in swallowing or unable to tolerate oral medication. 19. Subject with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication. 20. Live in the same household as currently enrolled subject. 21. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects achieving PASI 75 (equal to a 75% reduction in PASI) at Week 16. 2. Proportion of subjects achieving a score of ââ?¬Å?clear equal to 0ââ?¬? or ââ?¬?almost clear equal to 1ââ?¬? in PGA at Week 16. Both these endpoints will be tested to show superiority of test product over placebo but only PASI 75 will be tested to show non-inferiority of test product versus reference product. Timepoint: 1. Proportion of subjects achieving PASI 75 (equal to a 75% reduction in PASI) at Week 16. 2. Proportion of subjects achieving a score of ââ?¬Å?clear equal to 0ââ?¬? or ââ?¬?almost clear equal to 1ââ?¬? in PGA at Week 16. Both these endpoints will be tested to show superiority of test product over placebo but only PASI 75 will be tested to show non-inferiority of test product versus reference product. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects achieving PASI 75 at Week 3 and Week 8. 2. Proportion of subjects achieving PASI 50 and PASI 90 at Week 3, Week 8, and Week 16. Timepoint: Baseline, Week 3, Week 8, Week 16, FU1, FU2 and FU3 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed