A clinical trial to study the effect of Lupin's study drug LLL-3348 in patients with moderate to severe chronic plaque type of Psoriasis.

Phase 3

• Conditions: Moderate to Severe Chronic Stable Plaque Type of Psoriasis

• Registration Number: CTRI/2009/091/000745
• Lead Sponsor: Lupin Research Park, 46 A/47A, Nande Village, Mulshi Taluka Pune-411042Maharashtra (India)

Brief Summary

This is a randomized, open lablel, parallel group, multi-centre study to compare the efficacy and safety of LLL-3348, in doses of 750 mg and 1000 mg administered once daily in comparison to methotrexate administered as per the Dermatologists judgment in the patient with moderate to severe chronic stable plaque type of psoriasis that will be conducted in 12 centers in India. The primary objectives are to determine the safety and tolerability of 750 mg of LLL-3348 once daily for 16 weeks as compared to Methotrexate and to determine the reduction in Psoriasis Area and Severity Index (PASI) score by >75% from baseline to the end of treatment. The secondary objectives are to compare the Physician's Global Assessment (PGA) score of LLL-3348 versus methotrexate after 1 month of treatment onwards till the end of treatment and to evaluate the rebound during the treatment or recurrence during treatment free follow-up period. In the initial phase IIb part of the study patients were randomized to LLL-3348 750 mg or 1000 mg or methotrexate. During this period, the objective was to find the safety profile of the different doses of LLL-3348. Following analysis of safety profile of the two doses at the end of phase IIb part of the study, the safe dose recommended is 750 mg for further Phase III study. The phase III part of the study is planned to establish further safety and efficacy. A new set of patients will now be randomized to LLL-3348 750 mg and methotrexate (Active comparator) in the phase III, randomized, parallel group, controlled study. In view of the large sample size and chronic nature of the disease a few more sites will be introduced. All the Assessors of the disease will be unaware of the trial medication given.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

• Patients with moderate to severe Chronic Stable Plaque Psoriasis with PASI score of ≥10.
• Either males or females aged 18 to 60 years.
• 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).
• Patients willing to sign Informed Consent Form.

Exclusion Criteria

• Patients who have been treated with Methotrexate within 2 months prior to screening.
• 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.
• Patients with guttate, erythrodermic, or pustular psoriasis and any other active skin conditions that would interfere with evaluations.
• 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.
• Patient with active uncontrolled infectious disease.
• 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 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.
• Patients who are doubtful to comply with study procedures for social or psychological reason 19.
• Patients with clinically significant cardiovascular, haemopoetic, endocr.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with > 75% reduction in PASI score from baseline to the end of treatment	PASI will be assessed at screening visit, at randomization and every 4 weeks till teh end of the study treatment

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients with > 50% reduction in PASI Score from baseline to the end of treatment i.e. after 16 Weeks2.Proportion of patients with improvement in PGA score 3.Incidence of rebound and relapse	PASI at Screening, Randomization, and at every visit every 4 weeks till end of the treatmentPGA at randomization and every 4 weeks till end of the treatment

Trial Locations

Locations (12)

Care Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Department of Skin, STD & Leprosy,; 🇮🇳 Delhi, DELHI, India

Dr. D Y Patil Hospital and Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Health & Research Centre,; 🇮🇳 India

J. J. Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

NHL Medical College; 🇮🇳 Ahmadabad, GUJARAT, India

NKP Salve Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Owaisi Hospital & Research Center; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

RENOVA Skin & Laser Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Skin Center; 🇮🇳 Indore, MADHYA PRADESH, India

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Care Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr. P. L. Chandravathi

Principal investigator

040-30418888

drchandra6@yahoo.co.in