Moderate to severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000018190
Conditions
Interventions
Product Code: LNP1955
Pharmaceutical Form: Capsule, soft
Current Sponsor code: LND400111
Other descriptive name: LND400111
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Lupin Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled in the Main part and MTX Add-on part of the study only if they meet all of the following criteria: 1. Male or female ambulatory patients aged 18 to 75 years (both inclusive) diagnosed with moderate-to-severe chronic stable plaque psoriasis with active disease, PASI score of = 10 and affected BSA = 10% and willing to provide informed consent; 2. Plaque psoriasis for at least 6 months prior to first dose of IP; 3. Are a candidate for phototherapy, photochemotherapy, or systemic therapy of plaque psoriasis (either naive or history of previous treatment); 4. Have not taken biologics within 6 months prior to administration of IP in this study; 5. Have not received systemic non-biologic psoriasis therapy (including, but not limited to, retinoids or vitamin D analogs, cyclophosphamide, cyclosporine, fumaric acid esters, pimecrolimus, or psoralen plus ultraviolet A light [PUVA]) or phototherapy within 4 weeks before the first dose of IP; 6. Have not received topical psoriasis treatment within 2 weeks before the first dose of IP; 7. Sexually active women of childbearing potential and men must be willing to use a reliable means of contraception (e.g. combined or progestogen only hormonal contraception, intrauterine devices [IUDs], surgical sterilization, double barrier, or vasectomized partner) during participation in this study and at least 2 months after the last dose of the IP OR postmenopausal women (aged greater than 45 years) with a history of amenorrhea for at least 1 year from the time of last menstrual cycle and have follicle-stimulating hormone (FSH) value indicating menopause with high reliability. Additional Inclusion Criteria for Main part: 1. Have not received MTX within 6 weeks prior to first dose of IP. Additional Inclusion Criteria for MTX Add-on part: 1. MTX naive and eligible to receive 7.5 mg MTX per week after having tolerated at least one dose (OR); 2. Patients receiving stable dose of 7.5 mg MTX per week. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be eligible for the study: 1. Current diagnosis of non-plaque forms of psoriasis, e.g., erythrodermic, guttate, or pustular psoriasis; 2. Known allergies or hypersensitivities that can have potential impact on patient's participation as determined by the Investigator; 3. Receiving drugs that are known to exacerbate psoriasis such as beta blockers, calcium channel blockers, antimalarial drugs or lithium; 4. Receiving oral or injectable (e.g., intraarticular, intramuscular, or intravenous) corticosteroids for any other condition; 5. Women who are pregnant, lactating, or planning pregnancy while enrolled in the study and at least 2 months after last dose of the IP; 6. History of infection requiring hospitalization, parenteral antimicrobial therapy, or otherwise judged clinically significant by the Investigator within 1 month prior to first dose of IP; 7. History of infection requiring oral antimicrobial therapy within 2 weeks prior to first dose of IP; 8. Patients with active tuberculosis, prior history of unsuccessfully treated tuberculosis (TB), latent TB (patients who are positive for test for latent TB e.g. QuantiFERON®-TB Gold test or appropriate test), or those who are at risk of developing TB; 9. History of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] - related lymphoproliferative disorder), history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease; 10. Patients suffering from significant acute or chronic, localized or disseminated infections (bacterial/fungal/viral) or sepsis, or patients with a history of recurring infections except Herpes simplex within 3 months prior to screening, or those who are at an increased risk of developing infections or sepsis as determined by the Investigator; 11. History or presence of any immunological disease or use of immunosuppressive or any therapy within a period that can have a 12. Recent live vaccine administration within 4 weeks prior to screening and during the study; 13. Have any known condition affecting oral absorption of drug e.g., (malabsorption syndrome), or not able to swallow IP for any reason; 14. History of abuse of alcohol, recreational, or illegal drugs within 1 year prior to screening; 15. Tested seropositive for Hepatitis B [Hepatitis B surface antigen (HBsAg)], and Hepatitis C virus (HCV), or human immunodeficiency virus (HIV); 16. History of malignancy in the last five years prior to screening, except curatively treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin; 17. Severe anemia (hemoglobin 3x upper limit of normal [ULN]; serum creatinine > 1.5 mg/dL (133 µmol/L) up to age 65 years and > ULN if age > 65 years) and serum bilirubin > 2 x ULN; 18. Significant abnormalities in the ECG; 19. Current or recent history of a severe, progressive, or uncontrolled disease or any clinically significant laboratory abnormality, which in the opinion of investigator makes the patient inappropriate for inclusion in this study. Additional Exclusion Criteria for MTX Add-on part: 1. Intolerance to MTX; 2. Contraindication to MTX (e.g., hypersensitivity to MTX or its excipients, blood dyscrasias etc.); 3. Receiving medicines with antifolate activity (e.g., co-trimox
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are as follows: • To assess the POE of LNP1955 and find an optimum dose in patients with moderate-to-severe plaque psoriasis;Secondary Objective: The secondary objectives of the study are as follows: • To assess the PD and safety of LNP1955 in comparison to placebo; • To explore the pharmacokinetics (PK) of LNP1955 and synergy with MTX in patients with moderate-to-severe plaque psoriasis in an open label study arm.;Primary end point(s): The proportion of patients achieving at least 75% reduction (PASI 75) from baseline in Psoriasis Area and Severity Index (PASI) after 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 12 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients achieving at least 75% reduction (PASI 75) from baseline in PASI after 4 and 8 weeks of treatment; • The proportion of patients achieving at least 50% reduction (PASI 50) from baseline in PASI after 4, 8, and 12 weeks of treatment; • The proportion of patients achieving at least 90% reduction (PASI 90) from baseline in PASI after 4, 8, and 12 weeks of treatment; • Improvement in Physician's Global Assessment (PGA) in psoriasis severity scores from baseline at 4, 8, and 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: 4 and 8 weeks from baseline for PASI 75 4,8 and 12 weeks from baseline for PASI 50, PASI 90 and PGA | — |
Countries
Hungary
Contacts
Public ContactProject Director
Lupin Limited
Outcome results
None listed