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CTRI Number  CTRI/2020/01/022728 [Registered on: 13/01/2020] Trial Registered Prospectively
Last Modified On: 02/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Phase II clinical study being done at multiple centres on moderate to severe Psoriasis patients. This is a double-blind, double-dummy, placebo-controlled and randomized trial where two doses of the study drug (AUR101) shall be assessed for Safety and Efficacy. 
Scientific Title of Study   A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized, Study to Evaluate the Efficacy and Safety of two doses of AUR101 in patients with Moderate-to-Severe Psoriasis 
Trial Acronym  INDUS-2 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhil Kumar 
Designation  Head & VP, Clinical Development 
Affiliation  Aurigene Discovery Technologies Limited (Subsidiary of Dr. Reddy’s Laboratories Limited) 
Address  39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  8071025578  
Fax    
Email  akhil_k@aurigene.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divyesh Mandavia  
Designation  Medical Lead 
Affiliation  Aurigene Discovery Technologies Limited (Subsidiary of Dr. Reddy’s Laboratories Limited) 
Address  39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  8071025588  
Fax    
Email  divyesh_m@aurigene.com  
 
Details of Contact Person
Public Query  
Name  Shilendra Pandey 
Designation  Clinical Operations Lead 
Affiliation  Aurigene Discovery Technologies Limited (Subsidiary of Dr. Reddy’s Laboratories Limited) 
Address  39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  8071025584  
Fax    
Email  shilendra_p@aurigene.com  
 
Source of Monetary or Material Support  
Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited 
 
Primary Sponsor  
Name  Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited 
Address  39-40 KIADB Industrial Area Phase II Electronic City Hosur Road Bangalore 560100 Karnataka India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     United States of America
India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neetu Sidana  Apex Hospitals Pvt Ltd  Department of Dermatology, SP-4 & 6, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur - 302017, Rajasthan, India
Jaipur
RAJASTHAN 		 9314661504

sidanasanjeev@rediffmail.com 
Dr Bela Shah  B.J Medical College & Civil Hospital  Department of dermatology, Wing No.3, Room No.139, skinOPD 1st Floor, OPDBuilding, Asarwa, Ahmedabad – 380016.
Ahmadabad
GUJARAT 		 9898059289

shah.drbela@gmail.com 
Dr Nandini A S  Kempegowda Institute of Medical Sciences  Department of dermatology, B Block, OPD Building, K.R.Road, V.V.Puram, Bangalaore 560004
Bangalore
KARNATAKA 		 9886829579

drnandinias2002@yahoo.co.in 
Dr Ishad Aggarwal  Life Line Diagnostic Centre Cum Nursing Home  Department of Dermatology, 4A, Wood street, Kankaria Estates, Kolkata 700016, West Bengal
Kolkata
WEST BENGAL 		 8100622846

ishad1984@gmail.com 
Dr Sushil Pande  NKP Salve Institute  Department of Dermatology, Digdoh Hills, Hingna, Nagpur 440019
Nagpur
MAHARASHTRA 		 9323511245

drsushilpande@gmail.com 
Dr Savitha A S  Sapthagiri Hospital  Ground floor, dermatology OPD, 15, Chikkasandra, Hesaraghatta, Main road, Bangalore 560090
Bangalore
KARNATAKA 		 9880512166

drsavithasomaiah@gmail.com 
Dr Shyamal Balki  Shree Hospital and Critical Care Centre  Department of dermatology, RMO Chamber, 1st Floor,799, Omnagar,Opposite to Tajshree Building, Mirchi Bazar Sakkardara Chowk, Umred Road, Nagpur 440009
Nagpur
MAHARASHTRA 		 9665477444

drshyamalb@gmail.com 
Dr Suneel Vartak  Sujata Birla Hospital & Medical Research Center  Department of dermatology, OPD No. 6, Ground Floor, Opp to Bytco College, Nashik road, Nashik 422101
Nashik
MAHARASHTRA 		 9373901829

suneel.vartak@gmail.com 
Dr Ashutosh Mehata  Triveni Polyclinic  Department of Dermatology, First Floor Shree JEE Krupa Apartment, Plot no 19-A near Wardhaman Nagar Petrol pump, Wardhaman Nagar square, Nagpur 440008, Maharashtra
Nagpur
MAHARASHTRA 		 9881873985

asmehta215@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Apex Hospitals Private Limited  Approved 
Institutional Ethics Committee NKP Salve Institute of Medical Sciences  Approved 
Institutional Ethics Committee of Life Line Diagnostic Centre Cum Nursing Home  Approved 
Institutional Ethics Committee Sapthagiri  Approved 
Institutional Ethics Committee, BJ Medical college and civil Hospital  Approved 
Kempegowda Institute of Medical Sciences Institutional Ethics Committee  Approved 
Shree Hospital Ethics Committee   Approved 
Triveni Polyclinic Institutional Ethics Committee  Approved 
Yash Society Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AUR-101  Two doses of AUR-101 in in approximately 90 patients with moderate-to-severe psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will be randomized to the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1. The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment. 
Comparator Agent  Placebo  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6
months before screening
2. Psoriasis of at least moderate severity, defined as PASI≥12 and involved
BSA≥10 % at screening and Day 1
3. Adult males or females, ≥ 18 to ≤ 65 years of age,
4. Ability to communicate well with the investigator and to comply with the
requirements of the entire study
5. Willingness to give written informed consent (prior to any study related
procedures being performed) and ability to adhere to the study restrictions and
assessments schedule. 
 
ExclusionCriteria 
Details  1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months
2. Efficacy failure on any biologic (e.g. interleukin (IL)-17 antibodies like
brodalumab or ixekizumab or anti-TNF agents like etanercept, infliximab or adalimumab) for the treatment of psoriasis
Note: Efficacy failure is defined as: A) Failure to achieve static Physician/
Investigator Global Assessment (PGA/IGA) of 0 to 2 (i.e. clear to mild) despite a continuous treatment with biologic at the approved (as in package insert) dose for at least 8 weeks And / Or B) After having an efficacious response, PGA/IGA increased to 3 or higher while receiving the approved (as in package insert) dose as maintenance
3. Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1.
4. BMI ≥ 35 kg/m2
5. Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents (e.g. secukinumab, briakinumab, tildrakizumab, ustekinumab etc.) within 6 months prior to study day 1
6. Current treatment or history of treatment for psoriasis with other biological
agents (e.g. adalimumab, etanercept, infliximab, alefacept etc.) within 3 months
prior to study day 1
7. Current treatment or history of treatment for psoriasis with non-biological systemic medications (including systemic steroids, methotrexate, cyclosporine etc.) or phototherapy within 4 weeks prior to study day 1.
8. Treatment with medicated topical agents (having active pharmaceutical ingredient that can impact the interfere with effect of the study drug; See Section 8.11 of protocol) within 2 weeks prior to study day 1.
9. History or presence of any medical or psychiatric disease, or clinically
significant laboratory



































 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients achieving PASI 75 response (i.e. 75% reduction from
baseline PASI score)  		 At the end of week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving PASI 75 response (i.e. 75% reduction from
baseline PASI score) 		 At the end of week 4 and 8. 
Proportion of patients achieving PASI 50 response (i.e. 50% reduction from
baseline PASI score) 		 At week 4, 8 and 12. 
Proportion of patients achieving IGA 0 or 1  At week 4, 8 and 12 
Percent change from baseline in PASI score  At week 4, 8 and 12 
Change from baseline in IGA scale  At week 4, 8 and 12 
Change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved  At week 4, 8 and 12 
Change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index
(DLQI) 		 At week 4,8 and 12 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   14/01/2020 
Date of Study Completion (India) 25/02/2021 
Date of First Enrollment (Global)  14/01/2020 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of two doses of AUR101 in patients
with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface
Area (BSA) involved ≥10%) will be randomized to the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1.
The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
A subset of approximately 25 patients, who consent, will be asked to come for plasma PK assessment in week 4 of dosing.
 
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