None listed
Conditions
Interventions
Intervention1: LLL-3348: 750mg once daily for 16 weeks(Phase III part)
Control Intervention1: Methotreaxate: Dose as per the clinical judgement of the Investigator for 16 weeks
Sponsors
Lupin Research Park,
46 A/47A, Nande Village, Mulshi Taluka
Pune-411042
Maharashtra (India)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with moderate to severe Chronic Stable Plaque Psoriasis with PASI score of ≥10. 2. Either males or females aged 18 to 60 years. 3. Patients who have not used for 2 weeks the anti-psoriatic therapy including ultraviolet D phototherapy, topical corticosteroids, vitamin A or D analogues or anthralin and who have not used for 4 weeks the anti-psoriatic therapy including PUVA, or any systemic anti-psoriatic treatment (systemic corticosteroids, immunosuppresants or any other systemic therapy including those on Methotrexate 2 months prior to screening). 4. Patients willing to sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients who have been treated with Methotrexate within 2 months prior to screening. 2. Pregnant women or nursing mothers 3. Women of child bearing potential & all men who are not willing to use reliable & effective contraceptive measures during the course of the study & at least 3 months after the last visit. 4. Patients with guttate, erythrodermic, or pustular psoriasis and any other active skin conditions that would interfere with evaluations. 5. Patients with a co-existing disease for which they have to take a concomitant medication with anti-psoriasis activity, such as: systemic corticosteroids, immuno-suppressants etc. 6. Patient with active uncontrolled infectious disease. 7. Patients with any serious disease that would interfere with the compliance to study protocol and proper completion of the trial 8. Patient with severe anemia, leucopenia or thrombocytopenia or any other clinically significant blood disorders 9. Patients with hepatitis/ fibrosis, cirrhosis, or any other active hepatic disorders or any abnormal kidney functions 10. Patients with uncontrolled diabetes & hypertension 11. Patients with any screening laboratory values that deviate from upper or lower limits of the reference range, except for clinically insignificant deviations as determined by the Investigator 12. Serum SGOT and SGPT > 3 X , Alkaline Phosphatase > 1.5 X , Creatinine > 1.5 X and Total bilirubin >1.5 X the Upper Limit of Normal (ULN) of the reference range at the screening assessment 13. Patient receiving medicines with antifolate properties (e.g., co-trimoxazole) 14. Patients with major psychiatric disorder that is not well controlled with treatment 15. Patients with history of acute myocardial infarction or stroke within 6 months of signing informed consent 16. Patients with Alcohol or drug dependence 17. Patients who have received any other investigational drug within 4 weeks prior to screening. 18. Patients who are doubtful to comply with study procedures for social or psychological reason 19. Patients with clinically significant cardiovascular, haemopoetic, endocr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with > 75% reduction in PASI score from baseline to the end of treatmentTimepoint: PASI will be assessed at screening visit, at randomization and every 4 weeks till teh end of the study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with > 50% reduction in PASI Score from baseline to the end of treatment i.e. after 16 Weeks 2.Proportion of patients with improvement in PGA score 3.Incidence of rebound and relapseTimepoint: PASI at Screening, Randomization, and at every visit every 4 weeks till end of the treatment PGA at randomization and every 4 weeks till end of the treatment | — |
Countries
India
Contacts
Public ContactDr. Neelam Kardekar
Outcome results
None listed