CTRI Number |
CTRI/2017/10/010093 [Registered on: 13/10/2017] Trial Registered Prospectively |
Last Modified On: |
26/11/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Biological |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study to compare effectiveness and safety of R-TPR-022/ Xolair® in Patients with asthma |
Scientific Title of Study
|
Prospective, multi-center, randomized, double-blind,
two-arm, parallel group, active control, comparative
clinical study to evaluate efficacy and safety of R-TPR-
022 / Xolair® in patients with moderate to severe
persistent asthma. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
RLS/RES/2016/01_V_1_Administrative_amendment_1_08Jun2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jamila Joseph |
Designation |
SVP & Head, RLS Clinical Research |
Affiliation |
Reliance Life Sciences Pvt. Ltd |
Address |
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA
Thane MAHARASHTRA 400701 India |
Phone |
02240678206 |
Fax |
02240678299 |
Email |
jamila.joseph@ril.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shashank Deoghare |
Designation |
Medical Monitor |
Affiliation |
Reliance Life Sciences Pvt. Ltd |
Address |
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA
Thane MAHARASHTRA 400701 India |
Phone |
02240678287 |
Fax |
02240678299 |
Email |
shashank.deoghare@relbio.com |
|
Details of Contact Person Public Query
|
Name |
Ravikiran Payghan |
Designation |
Project Manager |
Affiliation |
Reliance Life Sciences Pvt. Ltd |
Address |
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA
Thane MAHARASHTRA 400701 India |
Phone |
02240678213 |
Fax |
02240678299 |
Email |
Ravikiran.Payghan@relbio.com |
|
Source of Monetary or Material Support
|
Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
|
Primary Sponsor
|
Name |
Reliance Life sciences Pvt Ltd |
Address |
Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 11 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rahul Lokhande |
B.J. Government Medical College and Sassoon General Hospitals |
Department no. 34,Department of TB and Chest,Ground floor, Sassoon Road, Somwar Peth,Pune 411001
Pune MAHARASHTRA |
91-020-26128000 91-020-26126868 drlokhander@gmail.com |
Dr Manish Jain |
Bansal Hospital and Research Center |
Department of Pulmonology, 04, Janakpuri-1st, Imli Phatak, Jaipur-302025 Jaipur RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
Dr Anand Kumar |
Department of Pulmonology, GSVM Medical College, Kanpur |
Department of Pulmonology Chest Hospital second floor Ward no 6 Near Rawatpur Crossing,Kanpur-208002 Kanpur Nagar UTTAR PRADESH |
7860965384
pulmonology.crc@gmail.com |
Dr Sushant Meshram |
Government Medical College and Hospital, Nagpur |
Department of Pulmonory Medicine and Critical Care, 4 Floor, Ward No. 43, Superficiality Hospital,Medical College Square, Nagpur-440003 Nagpur MAHARASHTRA |
9860990379
drsushant.in@gmail.com |
Dr Jyothi Hattiholi |
KLES Dr. Prabhakar Kore Hospital & Medical Research center |
OPD No. 18, 1st Floor,
KLES Dr. Prabhakar Kore Hospital & M.R.C, NH 4, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA |
09164012011
pulmojyoti@gmail.com |
Dr Nilkanth Awad |
Lokmanya Tilak Municipal Medical College And General Hospital |
Department of Respiratory Diseases, 1st Floor, College Building, Dr. Babasaheb Ambedkar Road, Road No.18, Sion-West, Mumbai-400022 Mumbai MAHARASHTRA |
9322252708
nta1960@gmail.com |
Dr Sumer Sanjiv Choudhary |
N.K.P. Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Nagpur |
Department of Respiratory,sleep and Critical Medicine, 4 Floor, OPD, Digdoh Hills, Hingna Road,Nagpur-440019 Nagpur MAHARASHTRA |
9405700834
psuryawanshi@gddexperts.com |
Dr Ramesh Chandra Sahoo |
Omega Hospital |
Basement OPD B-11,
Omega Hospital, Mahaveer Circle, Kankanady ,Mangalore-575002 Karnataka Udupi KARNATAKA |
09844145770
Drrcs.epsilon@epsilon.net |
Dr Amit Sambare |
Sanjeevan Hospital |
Department of Medicine,OPD Room No 1,Ground floor,Plot No.23,Off Karve Road, Erandawane,Pune 411004 Pune MAHARASHTRA |
91-020-67250000 91-020-67250015 drasambare@gmail.com |
Dr Narendra Khippal |
SMS Medical College and Hospital |
Institute of Respiratory Diseases,SMS Medical College & Attached Hospitals,B-2, Subhash Nagar Shopping Center, Shastri Nagar, Jaipur- 302016
Jaipur RAJASTHAN |
09829017619
drnkhippal@rediffmail.com |
Dr Ashish Shankarrao Deshmukh |
United CIIGMA Institute of Medical Science Pvt. Ltd |
OPD 1st Floor Or 6th floor research department,
United CIIGMA Institute of Medical Science Pvt. Ltd, Plot no 6,7 survey no 10 Shahnoorwadi Daragah Road Aurangabad 431005Â Maharashtra Aurangabad MAHARASHTRA |
09657715067
Drdeshmukh.uch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 11 |
Name of Committee |
Approval Status |
Ethics Committee GSVM Medical College, Kanpur |
Approved |
Ethics Committee K.M.H. and G.C.H,Aurangabad |
Approved |
Ethics Committee Sanjeevan Hospital |
Approved |
Ethics Committee SMS Medical College, Jaipur |
Approved |
Ethics Committee,KLE University |
Approved |
Institutional Ethics Committee (IEC),Department of Pharmacology,Govt. Medical College, Nagpur |
Approved |
Institutional Ethics Committee B J Medical College and Sassoon General Hospitals, Pune |
Approved |
Institutional Ethics Committee Human Research LTMMC & GH |
Approved |
Institutional Ethics Committee, Bansal Hospital and Research Centre, Jaipur |
Approved |
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Nagpur |
Approved |
Omega Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients with
moderate to severe persistent asthma, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
R-TPR-022 |
Administered as per the body weight and IgE levels subcutaneously, every 2 or 4 weeks for 24 weeks |
Comparator Agent |
Xolair® |
Administered as per the body weight and IgE levels subcutaneously, every 2 or 4 weeks for 24 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
- Males and females patients of ≥18-65 years of age, inclusive.
- Patient with the diagnosis of moderate to severe persistent asthma >1 year duration
- Able to understand the study procedures, the risks involved, willing to provide written Informed Consent,
and able to adhere to study schedules and requirements.
- Subjects must have the ability to understand and comply with instructions and be able to complete
study-related forms and questionnaires.
- Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last
injection of study medication
- Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. |
|
ExclusionCriteria |
Details |
- Any Clinically significant abnormal laboratory investigations or physical examination findings which
may pose risk to the patients as assessed by investigator at screening visit.
- Prior Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening Visit.
- Patient with history of near fatal or life-threatening (including intubation) asthma within the past year
prior to screening visit.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic
composition to Omalizumab or its any excipients. History of illicit drug use within one year prior to
randomization.
- Prior use of Omalizumab
- Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the
Screening Visit.
- Significant, non-reversible, active pulmonary disease.
- Current smoker or smoking history within 12 months prior to the Screening Visit.
- Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication; Clinically significant peripheral vascular disease; Uncontrolled diabetes; Serious active or uncontrolled infection
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an
investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- Inability to comply with study and/or follow-up procedures.
- Subjects with HIV, HBsAg, HCV test positive.
- History or presence of any form of cancer within the 10 years prior to randomization.
- Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study
- History or presence of any medical or psychiatric condition or disease, or laboratory abnormality or any other condition that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
- Participation in any clinical study of an investigational product within the previous 3 months |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The primary efficacy endpoint will be the incidence of clinically significant asthma exacerbations after first study dose administration till week 16. |
Week 16 |
|
Secondary Outcome
|
Outcome |
TimePoints |
PK and PD (free and total IgE) assessments |
First sample (pre-dose) will be collected within 1 hour prior to drug administration
(0.00 hour) and subsequent samples will be collected at fixed time intervals after first dose administration. |
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
09/12/2017 |
Date of Study Completion (India) |
11/05/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-022 / Xolair® in patients with moderate to severe persistent asthma. |