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
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
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 Ajit Nalawade
Coherence Pain & Arthritis Clinic
5th Floor, office No 510, Gagan Uno, Balkrishna Sakharam Dhole Patil opp. Vohman Cafe, near Ruby Hall Clinic, Pune, Maharashtra 411001 Pune MAHARASHTRA
8806389797
supremeindependentcommittee@gmail.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
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)= "470" Final Enrollment numbers achieved (India)="33"
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.