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CTRI Number  CTRI/2024/11/076338 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 22/08/2025
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 Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) 
Scientific Title of Study   A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) 
Trial Acronym  POETYK SLE-2 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-500700-22-00  EudraCT 
IM011-247 Amendment 02 Version 3.0 dated 07 Sep 2023  Protocol Number 
NCT05620407  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpi Sinha 
Designation  Associate Director, Country Head RCO India 
Affiliation  Bristol Myers Squibb India Pvt. Ltd. 
Address  Bristol Myers Squibb India Pvt. Ltd One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone(W)

Mumbai
MAHARASHTRA
400013
India 
Phone  2266288645  
Fax    
Email  Shilpi.Sinha@bms.com  
 
Details of Contact Person
Scientific Query  
Name  Kartik Doshi 
Designation  Associate Director Medical India 
Affiliation  Bristol Myers Squibb India Pvt. Ltd. 
Address  One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai-400013

Mumbai
MAHARASHTRA
400013
India 
Phone  2266288600  
Fax    
Email  Kartik.Doshi@bms.com  
 
Details of Contact Person
Public Query  
Name  Shilpi Sinha 
Designation  Associate Director Country Head RCO India 
Affiliation  Bristol Myers Squibb India Pvt Ltd 
Address  One international Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone(W), Mumbai-400013

Mumbai
MAHARASHTRA
400013
India 
Phone  02266288600  
Fax    
Email  Shilpi.Sinha@bms.com  
 
Source of Monetary or Material Support  
Bristol Myers Squibb India Private Limited 
 
Primary Sponsor  
Name  Bristol Myers Squibb India Private Limited 
Address  One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphinstone (W), Mumbai - 400013, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Brazil
Bulgaria
Chile
Czech Republic
Greece
Hungary
Japan
Mexico
Peru
Poland
Portugal
Singapore
Spain
Taiwan
Turkey
United Kingdom
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 Uma Kumar  All India Institute of Medical Sciences (AIIMS)  Department of Rheumatology, Room No 4076, 4th Floor, Teaching block, Ansari Nagar, New Delhi - 110029, India
New Delhi
DELHI 		 9868217040

umaakumar@yahoo.co.in 
Dr Piyush Joshi  Avron Hospitals Pvt Ltd  4 Santiniketan Park, Nr. Sardar Patel Statue, Naranpura, Ahmedabad-380013, Gujarat
Ahmadabad
GUJARAT 		 8879102056

drpiyushjoshicr@gmail.com 
Dr Ashish Jacob Mathew  Christian Medical College  Department of Clinical Immunology and Rheumatology, Ida Scudder Road, Vellore - 632004, Tamil Nadu, India
Vellore
TAMIL NADU 		 9994510495

ashishjacobmathew@gmail.com 
Dr Rajkiran Dudam  HRC Hospital  1-10-44/20, Near Prakash Nagar Metro Station, Begumpet, Hyderabad, Telangana-500016
Hyderabad
TELANGANA 		 9849365340

rajkirancare6@gmail.com 
Dr Smruti Sanjay Ramteke   Jasleen Hospital  Panchsheel Square, opp. to big Bazar, Dhantoli, Nagpur, 440012, Maharashtra, India.
Nagpur
MAHARASHTRA 		 982314680

sramteke@rediffmail.com 
Dr Subramanian Ramaswamy  JSS Hospital  Department of Immunology and Rheumatology, M G Road, Ramachandra Agrahara, Mysore-570004, Karnataka
Mysore
KARNATAKA 		 9945472441

subsan05@gmail.com 
Dr Veeravalli Sarathchandra Mouli  Krishna Institute of Medical Sciences (KIMS) Limited  Department of Rheumatology and Clinical Immunology, block 03, 1st Floor,1-8-31/1, Minister Road, Secunderabad - 500003, Telangana, India
Hyderabad
TELANGANA 		 9866000685

sarath10@hotmail.com 
Dr Anuj N Shukla  Ratan Multi Speciality Hospital  Isanpur Road, Surgeon Triangle, Isanpur, Ahmedabad, Gujarat, India, 382443.
Ahmadabad
GUJARAT 		 9792005003

dranujshuklacr21@gmail.com 
Dr Vikram Muralidar Haridas  Sushruta Multispecialty Hospital and Research Center Pvt Ltd  #314, Research Room, Old Deluxe Ward, Hubli-Dharwad Road, Vidyanagar, Hubballi 580021, Karnataka, India
Dharwad
KARNATAKA 		 9343649883

drvikramharidas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Avron Multispecilaity Hospitals Ethics Committee  Approved 
Institute Ethics Committee, AIIMS  Approved 
Institutional Ethics Committe, Aatman Hospitale  Approved 
Institutional Ethics Committe, JSS Hospitale  Approved 
Institutional Ethics Committe, Rughwani Child Care  Approved 
Institutional Review Board, Christian Medical College  Approved 
KIMS Ethics Committee  Approved 
S2J Independent Ethics Committee  Approved 
Sushruta Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
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  Deucravacitinib tablet  Dose is 3mg for deucravacitinib tablet. participant will take 1 tablet twice daily orally. The treatment period will of 52 weeks of double blinded phase followed by 104 weeks of open label phase. The total duration of treatment will be 156 weeks (double blinded phase and open label phase) 
Comparator Agent  PBO to match deucravacitinib tablet  The study treatment will be administered in a double-blind manner for the 52-week treatment period and in an open-label manner for the 104-week optional LTE period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) Diagnosed with SLE at least 24weeks before the screening visit b) Meet the European Alliance of Associations for Rheumatology or American College of Rheumatology 2019 classification criteria for SLE c) One of the following as determined by the central laboratory at screening positive antinuclear antibodies which is greater or equal than ration 1 is to 80 OR positive anti dsDNA OR positive anti-Smith antibody anti Sm
d) Total SLEDAI 2K score is equal or greater than 6 points and clinical SLEDAI 2K score is equal to or greater than 4 points with joint involvement and or cutaneous vasculitis and or rash and must be confirmed by RRG e) At least 1 BILAG A or 2 BILAG B grades must be present at screening including at least 1 of the following BILAG based protocol specific manifestations of mucocutaneous or musculoskeletal SLE must be confirmed by RRG
i) BILAGA or B grade in the mucocutaneous body system. If a BILAGB grade for mucocutaneous disease is due to BILAG 6 mild skin eruption the total score of the erythema and scale components of the Cutaneous Lupus Erythematosus Disease Area and Severity Index CLASI disease activity must be greater than or equal to 3 excluding mucous membrane ulcerations and nonscarring alopecia
ii) Modified BILAG A or B score in the musculoskeletal body system due to active polyarthritis defined as follows (1) BILAG A severe arthritis BILAG 41 manifested by observed active synovitis in is greater than or equal to 6 joints(a)Hips shoulders neck low back and temporomandibular joint may not count toward the total number of joints with active synovitis for the purposes of study entry(b)There must be marked loss of functional range of movements and significant impairment of basic activities of daily living ADL This is defined as follows
(i)Requiring the assistance of another person or an assistive device in ambulation toileting and grooming including bathing dressing and feeding oneself At least 1 must be present and documented in source
1) Not responsive to therapy such as CS prednisone or equivalent greater than or equal to 10mg per day participants who are intolerant of or otherwise unable to take CS should be discussed with RRG or the Medical Monitor
2) Impairment from arthritis must have been present on several days that is greater than 4days cumulatively over the past 4weeks and must be present at the time of the screening visit
(2) BILAG B moderate arthritis or tendonitis or tenosynovitis BILAG 42 defined as tendonitis or tenosynovitis or active synovitis in greater than or equal to 3joints observed through history
(a)Hips shoulders neck low back and temporomandibular joint may not count toward the total number of joints with active synovitis for the purposes of study entry
(b)There must be some loss of functional range of movements due to arthritis as manifested by difficulty in performing any one of the instrumental ADL such as cooking driving using the telephone or computer shopping cleaning etc that has been present on several days ie greater than 4days over the last 4weeks and is present at the time of the screening visit 3) If there is no A grade present in the mucocutaneous body system or in the musculoskeletal body system and if there is only 1 B grade present in the mucocutaneous or musculoskeletal body system per specifications above then there must be at least 1 B grade in another body system for a total of 2 BILAG B body system grades
f) At least one of the following SLE background therapies immunosuppressant and or
antimalarial is required for is greater than or equal to 12weeks before the screening visit must be at a stable dose for greater than or equal to8weeks before the screening visit and must remain stable until the Week 52 visit
i)Immunosuppressants participants can only be on ONE immunosuppressant
(1) azathioprine maximum 200mg per day
(2) 6 mercaptopurine 6 MP maximum 200mg per day
(3) methotrexate MTX maximum 25 mg per week dose and route of administration of
MTX may not be changed for 8weeks before the screening visit and throughout study participation
(4) leflunomide maximum20mg per day
(5) tacrolimus maximum 0.2mg per kg per day
(6) mizoribine maximum 150mg per day
(7) mycophenolate mofetil MMF mycophenolic acid MPA Note: Participants who are receiving MMF as a maintenance therapy up to a maximum of 2000 mg per day or equivalent MPA dose 1440 mg per day may participate in the study If a participant requires higher doses up to 3000 mg per day MMF or equivalent MPA dose 2160 mg per day and is tolerating it without toxicity please discuss with the RRG or Medical Monitor Treatment may be interrupted due to neutropenia per the
product label Note If a listed immunosuppressant above requires wash out and is not included in
Appendix 7 the time period for washout shall be 2 weeks or5 half lives prior to screening whichever is longer
i) Antimalarials chloroquine hydroxychloroquine or quinacrine monotherapy use is permitted Dosing shall be commensurate with regional guidance and investigator judgment Participants can only be on ONE antimalarial but can be on both an immunosuppressant and an antimalarial It is recommended that participants receiving antimalarials undergo screening for retinal toxicity in accordance with local guidelines
Note Should a listed antimalarial above require washout the time period for washout shall be 2 weeks prior to Screening
g) OCS prednisone or equivalent background therapy is permitted but not required For participants taking OCS the dose must be stable for greater than or equal to 2weeks before the screening visit cannot exceed 30mg per day at screening and must remain stable until the Week4 visit Participants can be on an OCS as well as an antimalarial and or an immunosuppressant
Further specifications are as follows
•Topical CS low to moderate potency is permitted but a stable regimen must be followed and cannot be used on an as needed basis
•Inhaled CS for non-lupus conditions is permitted and will not count against the
maximum CS dose
h)Oral and or topical non steroidal anti inflammatory drugs NSAIDs including aspirin or
cyclooxygenase 2 inhibitors are allowed as a stable therapy or on an as needed basis
provided they are taken within the dose and frequency ranges on their respective labels
Participants on NSAIDs must agree to follow restrictions around study visits
i) Opioid analgesics are allowed provided the doses administered do not exceed 30 mg of
morphine per day or equivalent Participants on opioids must agree to follow restrictions
around study visits
j) All participants must undergo eligibility review and receive confirmation of eligibility by
the RRG prior to randomization
 
 
ExclusionCriteria 
Details  1)Medical Conditions
a) Diagnosis of drug induced SLE rather than idiopathic SLE instances in which prior
diagnosis of drug induced SLE was later determined to be unrelated to medication must be
discussed with the RRG b) Other autoimmune diseases eg multiple sclerosis psoriasis inflammatory bowel disease
etc are excluded Participants with type I autoimmune diabetes mellitus thyroid
autoimmune disease Celiac disease or secondary Sjogrenss syndrome are not excluded
c)SLE overlap syndromes including but not limited to rheumatoid arthritis scleroderma and mixed connective tissue disease are excluded
d)Concomitant fibromyalgia chronic fatigue syndrome or chronic pain syndrome if the
symptoms or therapy are likely to significantly impact the assessment or interpretation of
SLE disease manifestations and activity based on discussion with eligibility reviewers
e) Any of the following, which could potentially increase the risk of thrombosis
i)Confirmed diagnosis of APS as defined by the Sapporo criteria refer to Appendix5
(1) if there has been a thrombotic event or pregnancy morbidity within 12 months
before screening
(2) if there has been a thrombotic event or pregnancy morbidity more than 12months
before screening and participant is not maintained on appropriate therapy
ii)History of catastrophic antiphospholipid syndrome CAPS
iii)Participants with no diagnosis of antiphospholipid syndrome APS and with a positive
result for antiphospholipid antibodies at screening plus history of thrombosis or pregnancy morbidity must be reviewed by EEAC for possible increased risk for thrombosis which could be exclusionary
f) Active or unstable lupus neuropsychiatric manifestations including but not limited to any
condition defined by BILAG A criteria
g) Active severe Class III and IV lupus nephritis that requires or may require treatment with
cytotoxic agents or high dose CS are excluded Participants with prior controlled renal disease with serum creatinine less than or equal to 2× upper limit of normal ULN and either residual proteinuria up to 3 g per day or a urine protein is to creatinine ratio UPCR of 3 mg per mg or 339mg per mmol are allowed Stability of renal disease must be documented with at least 2measurements of proteinuria or UPCR over the past 6 months 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI4  Proportion of participants who achieve SRI4 response at Week52
Reduction from Baseline of greater than or equal to 4points in the Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI 2K score and
No new BILAG A or not more than 1 new BILAGB organ domain scores and
No worsening in PGA less than 0.3point increase from baseline using a visual analog scale VAS with anchor scores ranging from 0 to 3 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of participants who achieve BICLA response at Week52
Proportion of participants who achieve both SRI 4 and BICLA dual responders at Week52
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index
CLASI activity score greater than or equal to 10 at baseline who achieve a CLASI response defined as a decrease of greater than or equal to 50 percent from baseline CLASI activity score at Week52
Proportion of participants who achieve LLDAS at Week52
Proportion of participants taking less than or equal to 7.5mgperday prednisone or equivalent at Week24 with no dose increase beyond protocol-specified limits to Week52
Proportion of participants with greater than equal to 6 active tender swollen joints at baseline who achieve at least 50 percent from baseline reduction in active tender swollen joints at Week52 		 Week 52 
Change from baseline in patient reported fatigue
according to FACIT Fatigue at Week52 		 week 52 
 
Target Sample Size   Total Sample Size="490"
Sample Size from India="15" 
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)   20/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/01/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="2"
Days="14" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
This Phase3 study is designed to evaluate the efficacy and safety of 3mgdeucravacitinib BID versus placebo in an active moderate-to-severe SLE population.
Study Duration: Approximately 60weeks for participants who do not enroll into the optional LTE period and approximately 164weeks for participants who enroll into the optional LTE period.
 
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