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CTRI Number  CTRI/2025/06/089546 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
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 Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (OPUS-1)  
Scientific Title of Study   A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallelgroup Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-002814-17  EudraCT 
2024-515870-28  Other 
NCT05648500  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanna C Ganapathi 
Designation  Head of Global Clinical Strategy & Innovation Clinical 
Affiliation  Mylan Pharmaceuticals Private Limited 
Address  Mylan Pharmaceuticals Private Limited Prestige Platina Tech Park, Kadubeesanahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560103
India 
Phone  08066728952  
Fax    
Email  PrasannaC.Ganapathi@viatris.com  
 
Details of Contact Person
Public Query  
Name  Rajesh Nachankar 
Designation  Associate Vice President Clinical 
Affiliation  Mylan Pharmaceuticals Private Limited 
Address  Mylan Pharmaceuticals Private Limited Prestige Platina Tech Park, Kadubeesanahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560103
India 
Phone  08066728951  
Fax    
Email  Rajesh.Nachankar@viatris.com  
 
Source of Monetary or Material Support  
Idorsia Pharmaceuticals Ltd. Hegenheimermattweg 91, 4123 Allschwil, Switzerland 
 
Primary Sponsor  
Name  Idorsia Phamaceuticals Ltd 
Address  Hegenheimermattweg 91, 4123 Allschwil, Switzerland  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Mylan Pharmaceuticals Pvt Ltd  Mylan Pharmaceuticals Pvt. Ltd. Plot No.564 A 22, Road No.92, Jubilee Hills , Hyderabad, 500 096, Telangana, India. 
 
Countries of Recruitment     France
Greece
Mexico
Philippines
Poland
Romania
Taiwan
United States of America
Argentina
Brazil
Bulgaria
Colombia
Democratic People's Republic of Korea
India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Pratap Jadhav  Assure Care Plus Hospital  4th & 5th Floor, Research Department, Star Plus Complex, Lam Road, Near Muktidham Temple, Opp., NMC Divisional Office, Nashik Road, Nashik - 422101, Maharashtra, India
Nashik
MAHARASHTRA 		 8358933951

drpraveenjadhav@rediffmail.com 
Dr Chandrashekara S  ChanRe Rheumatology and Immunology Centre and Research  ChanRe Rheumatology and Immunology Centre and Research Room No. 1, Ground and 1st Floor, No. 414/65, 20th Main, West of Chord Road, 1st Block, Rajajinagar, Bengaluru - 560010, Karnataka, India.
Bangalore
KARNATAKA 		 9845071151

chandrashekara_s@yahoo.com 
Dr Rahul Jain   Maharaja Agrasen Superspeciality Hospital  B-11, Clinical Research Department, Maharaja Agrasen Super speciality hospital,Sector 7, Central Spine, Vidyadhar Nagar, Jaipur 302039
Jaipur
RAJASTHAN 		 8826264447

Drrahuljain.mah@gmail.com 
Dr Liza Rajasekhar   Nizam’s Institute of Medical Sciences  Department of Immunology & Rheumatology, 4th floor Millenium Block, Punjagutta, Hyderabad – 500082, Telangana, India
Hyderabad
TELANGANA 		 9391008618

lizarajasekhar@gmail.com 
Dr Puja Pushkarkumar Srivastava   Radiance Hospitals  3rd & 4th Floor, Shital Varsha III, Nr. Vijay Char Rasta, Navrangpura, Ahmedabad – 380009, Gujarat, India
Ahmadabad
GUJARAT 		 8155891234

dr.pujasrivastava@gmail.com 
Dr Arul Raja Murugan Ponniah Subramanian  Rajiv Gandhi Government General Hospital  Room No. 512B, 1st Floor, Department of Rheumatology, Medical College, GH Post Office, Poonamalle High Road, 3, Grand Southern Trunk Road, Park Town, Near Chennai Central, Chennai - 600003, Tamil Nadu, India
Chennai
TAMIL NADU 		 9840665286

drarul.ct@gmail.com 
Dr Vishnu Devakinandan Sharma  Sangini Hospital  1st Floor, Santorini Square, Near Abhishree Complex, Opp. Star Bazaar Lane, Near Jodhpur Cross Roads, Satellite, Ahmedabad - 380015, Gujarat, India
Ahmadabad
GUJARAT 		 8511555477

drvishnusharma@yahoo.co.in 
Dr Sachin Vitthalrao Dhote  Shree Hospital and Critical Care Centre  1st and 3rd Floor, Research Department, 799, Om Nagar, Opp. Tajshree Building, Sakkardar Sq., Nagpur – 440009, Maharashtra, India
Nagpur
MAHARASHTRA 		 9823343626

drsachindhote123@gmail.com 
Dr Vineeta Shobha  St. Johns Medical College Hospital  3rd Floor, Department of Clinical Immunology and Rheumatology, St. John’s National Academy of Health Sciences, St. John’s Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India
Bangalore
KARNATAKA 		 8022065953

vineeta_shobha@yahoo.co.in 
Dr Romi Kirankumar Shah  Unity Trauma Center and ICU (Unity Hospital)  Unity Hospital Ethics Committee, N- 4 Janki Park Society, Aai Mata Road, Parvat Patiya, Surat - 395010, Gujarat, India
Surat
GUJARAT 		 8238004052

drromikshah@gmail.com 
Dr Archana Uppin   Vijaya Ortho & Trauma Centre  Vijaya Ortho & Trauma Centre, Clinical Research Room, 4th Floor ,Opp :BIMS, Vijaya Road, Ayodhya Nagar, Belagavi, Karnataka, India- 590001.
Belgaum
KARNATAKA 		 9844175418

drarchanak85@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Zest Ethics LLP  Approved 
IEC, Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee CRICR ChanRe Rheumatology Immunology Centre Research  Submittted/Under Review 
Institutional Ethics Committee St. Johns Medical College Hospital,  Submittted/Under Review 
Institutional Ethics Committee, Assure Care Plus Hospital  Approved 
Institutional Ethics Committee, Rajiv Gandhi Government General Hospital  Approved 
NIMS Institutional Ethics Committee  Approved 
Sangini Hospital Ethics Committee  Approved 
Shree Hospital Ethics Committee  Approved 
Supreme Independent Ethics Committee  Approved 
Swarnim Ethics Committee  Approved 
Unity Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M329||Systemic lupus erythematosus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cenerimod 4 mg  Cenerimod Cenerimod will be supplied as film-coated tablets at the dose of 4 mg. Other Names: • ACT-334441 Total Duration of Intervention: 12 Months 
Comparator Agent  Placebo  Matching placebo will be supplied as identical filmcoated tablets formulated with the same excipients but without the active ingredient, cenerimod. Total Duration of Placebo: 12 Months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism or American College of Rheumatology Criteria.
2. A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score greater than or equal to 6 and clinical mSLEDAI-2K score greater than or equal to 4.
3. British Isles Lupus Assessment Group-2004 (BILAG) Grade B in at least 2 organ systems or a BILAG Grade A in at least 1 organ system.


 
 
ExclusionCriteria 
Details  1.Pregnant, planning to be become pregnant up to Final Study Visit or lactating woman
2. Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE.
3. A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline. Response on SRI-4 is defined as
• Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index 2000 score (mSLEDAI-2K [SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K]), and
• No new British Isles Lupus Assessment Group 2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and
• No worsening from baseline in subjects’ lupus disease activity, where worsening is defined as an increase greater than or equal to 0.30 points on a 3 point Physician’s Global Assessment visual analog scale (PGA VAS), and
• No violation of specified medication rules detailed in the core protocol.
 		 At Month 12 compared to Day 1
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline.  At Month 12 compared to Day 1  
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/02/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. 

The main questions it aims to answer are:

• How well cenerimod works on top of the treatment already being administered.

• How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.

Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.

In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months. 
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