| CTRI Number |
CTRI/2009/091/000745 [Registered on: 08/10/2009] |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Cluster Randomized Trial |
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Public Title of Study
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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. |
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Scientific Title of Study
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A Phase IIb/III, Multi-Center, Randomized, Parallel Group, Controlled Study to Evaluate the Efficacy and Safety of 750 mg and 1000 mg of LLL-3348 of Lupin Limited in Moderate to Severe Chronic Stable Plaque Type of Psoriasis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| LRP/CTP/019/3348/IIb/III/01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
As per the site details |
| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Rajesh Kumawat |
| Designation |
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| Affiliation |
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| Address |
Lupin Limited,
Lupin Research Park
Pune
MAHARASHTRA
India |
| Phone |
+91-20-66749400 |
| Fax |
|
| Email |
rajeshkumawat@lupinpharma.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Dr. Neelam Kardekar |
| Designation |
Assistant Director |
| Affiliation |
Lupin Limited |
| Address |
Lupin Limited,
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India |
| Phone |
020-66747372 |
| Fax |
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| Email |
neelamkardekar@lupinpharma.com |
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Source of Monetary or Material Support
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| Council of Scientific & Industrial Research (CSIR), India(Under NMITLI programme) |
| Lupin Research Park,
46 A/47A, Nande Village, Mulshi Taluka
Pune-411042
Maharashtra (India)
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Primary Sponsor
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| Name |
Lupin Research Park,
46 A/47A, Nande Village, Mulshi Taluka
Pune-411042
Maharashtra (India)
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. P. L. Chandravathi |
Care Hospital |
,-
Hyderabad
ANDHRA PRADESH |
040-30418888
drchandra6@yahoo.co.in |
| Dr. H. K. Kar |
Department of Skin, STD & Leprosy, |
RML Hospital, ,-
New Delhi
DELHI |
011-23362880
hkkar_2000@yahoo.com |
| Dr. Nitin Choudhari |
Dr. D Y Patil Hospital and Research Center |
,-
Pune
MAHARASHTRA |
020-25467933
drnitinchaudhari@yahoo.com |
| Dr. Remadevi Janamma |
Health & Research Centre, |
,-
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| Dr. Mahendra Kura |
J. J. Hospital |
,-
Mumbai
MAHARASHTRA |
022-23735555-2290
drkura@gmail.com |
| Dr. (Mrs) Ranjan Raval |
NHL Medical College |
V.S. Hospital,-
Ahmadabad
GUJARAT |
079-26577621
ranjanmb@yahoo.com |
| Dr. Sushil Pande |
NKP Salve Institute of Medical Sciences |
,-
Nagpur
MAHARASHTRA |
095-07104-236290/91
drsushilpande@gmail.com |
| Dr. Alur Sainath Kumar |
Owaisi Hospital & Research Center |
,-
Hyderabad
ANDHRA PRADESH |
040-24340144
dr_askumar@yahoo.com |
| Dr. Puneet Goyal |
RENOVA Skin & Laser Clinic |
Sector 9, Shoping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar,-302020
Jaipur
RAJASTHAN |
09414027285
puneetgoyaljpr@yahoo.co.in |
| Dr. Jayesh Kothari |
Skin Center |
301, Manas Bhawan, ,11, R.N.T. Marg, -
Indore
MADHYA PRADESH |
0731-2513392
kotharidrjayesh@gmail.com |
| Dr. Bhawesh K Swarnkar |
Skin Clinic, |
Anand Bazaar Main Road, ,Near Bank of Baroda ATM, Indore-
Indore
MADHYA PRADESH |
0731-4060820
swarnakar_b@yahoo.com |
| Dr. Deepak Mathur |
SMS Hospital |
Department Of Skin & STD,-
Jaipur
RAJASTHAN |
0141-2708666/7
drdkmathur@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, CHL-Apollo Hospital, Indore |
Approved |
| IEC, SMS Medical College, Jaipur |
Approved |
| Independent Human Ethics Committee,Health & Research Centre,Trivandrum |
Approved |
| Institutional EC, Care Hospital |
Approved |
| Institutional EC, Deccan College of Medical Sciences |
Approved |
| Institutional EC, Grant Medical College, Mumbai |
Approved |
| Institutional EC, NKP Salve Institute of Medical Sciences & LMH |
Approved |
| Institutional EC, V.s. Hospital, Ahmedabad |
Approved |
| Institutional Ethical Committee, Dr. D. Y. Patil University?s |
Approved |
| Institutional Ethics Committee, Dr. Ram Manohar Lohia Hospital, Delhi |
Approved |
| Swasthya Kalyan Ethics Committee, Jaipur |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Moderate to Severe Chronic Stable Plaque Type of Psoriasis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
LLL-3348 |
750mg once daily for 16 weeks(Phase III part) |
| Comparator Agent |
Methotreaxate |
Dose as per the clinical judgement of the Investigator for 16 weeks |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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.
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| ExclusionCriteria |
| Details |
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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| 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 |
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Secondary Outcome
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| Outcome |
TimePoints |
| 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 relapse |
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
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Target Sample Size
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Total Sample Size="330"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/07/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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.
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