Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06741969
Registration number
NCT06741969
Ethics application status
Date submitted
18/12/2024
Date registered
19/12/2024
Date last updated
3/07/2025
Titles & IDs
Public title
Nipocalimab in Moderate to Severe Sjogren's Disease
Query!
Scientific title
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
Query!
Secondary ID [1]
0
0
80202135SJS3001
Query!
Secondary ID [2]
0
0
80202135SJS3001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DAFFODIL
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sjogrens Syndrome
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Nipocalimab
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of care treatment
Experimental: Nipocalimab - Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Placebo comparator: Placebo - Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Treatment: Drugs: Nipocalimab
Nipocalimab SC.
Treatment: Drugs: Placebo
Placebo SC.
Treatment: Drugs: Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Query!
Assessment method [1]
0
0
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
Query!
Timepoint [1]
0
0
Baseline to Week 48
Query!
Secondary outcome [1]
0
0
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
Query!
Assessment method [1]
0
0
The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
Query!
Timepoint [1]
0
0
Baseline to Week 48
Query!
Secondary outcome [2]
0
0
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
Query!
Assessment method [2]
0
0
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Query!
Timepoint [2]
0
0
Baseline to Week 48
Query!
Secondary outcome [3]
0
0
Change from Baseline in ClinESSDAI Score at Week 8
Query!
Assessment method [3]
0
0
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
Query!
Timepoint [3]
0
0
Baseline to Week 8
Query!
Secondary outcome [4]
0
0
Change from Baseline in Stimulated Salivary Flow Rate at Week 48
Query!
Assessment method [4]
0
0
Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
Query!
Timepoint [4]
0
0
Baseline to Week 48
Query!
Secondary outcome [5]
0
0
Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
Query!
Assessment method [5]
0
0
Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Query!
Timepoint [5]
0
0
Baseline to Week 48
Query!
Secondary outcome [6]
0
0
Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
Query!
Assessment method [6]
0
0
Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.
Query!
Timepoint [6]
0
0
Baseline to Week 48
Query!
Secondary outcome [7]
0
0
Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
Query!
Assessment method [7]
0
0
ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK \& EU reference regions will be reported.
Query!
Timepoint [7]
0
0
Baseline to Week 48
Query!
Secondary outcome [8]
0
0
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
Query!
Assessment method [8]
0
0
FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.
Query!
Timepoint [8]
0
0
Baseline to Week 48
Query!
Eligibility
Key inclusion criteria
-
* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
* Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
* Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
* Total ClinESSDAI score greater than or equal to (>=) 5 at screening
* Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
* Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/12/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/06/2030
Query!
Actual
Query!
Sample size
Target
600
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Buenos Aires
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Ciudad de Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Quilmes
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
San Miguel De Tucuman
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Stockerau
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Brasilia
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Curitiba
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Porto Alegre
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Salvador
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Sao Jose do Rio Preto
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Sao Paulo
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Vitoria
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Beijing
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Chengdu
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Gui Yang Shi
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Hang Zhou Shi
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Nan Ning Shi
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Ningbo
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Tai Yuan Shi
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Koge
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Dresden
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Hamburg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Herne
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Munchen
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Chuo ku
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Fuchu
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Fukuoka
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Kawachi Nagano
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Naha
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Okayama
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Sapporo
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Sasebo
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Sendai
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Shimotsuga Gun
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Sumida ku
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Tokyo
Query!
Country [49]
0
0
Korea, Republic of
Query!
State/province [49]
0
0
Gwangju
Query!
Country [50]
0
0
Korea, Republic of
Query!
State/province [50]
0
0
Seoul
Query!
Country [51]
0
0
Korea, Republic of
Query!
State/province [51]
0
0
Suwon si
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Culiacan
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Guadalajara
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Merida
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Mexico
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
Queretaro
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Bydgoszcz
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Krakow
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Olsztyn
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Poznan
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Warsaw
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Warszawa
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Wroclaw
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Barcelona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Madrid
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Pamplona
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Santander
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Sevilla
Query!
Country [69]
0
0
Taiwan
Query!
State/province [69]
0
0
Hsinchu City
Query!
Country [70]
0
0
Taiwan
Query!
State/province [70]
0
0
Kaohsiung City
Query!
Country [71]
0
0
Taiwan
Query!
State/province [71]
0
0
Taipei
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Taoyuan
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Doncaster
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Greater London
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
Liverpool
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Peterborough
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Swindon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Query!
Trial website
https://clinicaltrials.gov/study/NCT06741969
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Study Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-434-4210
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06741969
Download to PDF