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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  
Name  Address 
NIL  NIL 
 
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 431005  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  
Status 
Approved/Obtained 
 
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. 
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