EFGARTIGIMOD ALFA for Primary Sjögren's syndrome

Inclusion criteria

• {"criterion_text":"- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF."}
• {"criterion_text":"- Meets the following criteria at screening: ACR/EULAR classification criteria 2016 pSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)"}

Exclusion criteria

• {"criterion_text":"- Secondary (also referred to as associated) Sjögren’s disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy)."}
• {"criterion_text":"- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening."}
• {"criterion_text":"- Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator’s opinion."}
• {"criterion_text":"- Use of cyclophosphamide ≤ 24 weeks prior to screening"}
• {"criterion_text":"- Anti-CD20 or anti-CD19 antibody received < 6 months before screening"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in clinESSDAI score at week 48","definition_or_measurement_approach":"Change from baseline measured using the clinESSDAI score at Week 48 (difference between baseline clinESSDAI and clinESSDAI at Week 48)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in ESSDAI score at week 48","definition_or_measurement_approach":"Change from baseline measured using the ESSDAI score at Week 48."}
• {"endpoint_text":"- Proportion of participants with low disease activity (clinESSDAI < 5) at week 48","definition_or_measurement_approach":"Proportion of participants whose clinESSDAI score is <5 at Week 48."}
• {"endpoint_text":"- Proportion of responders on STAR (defined as ≥ 5 points) at week 48","definition_or_measurement_approach":"Proportion of participants meeting STAR response threshold (improvement ≥5 points) at Week 48."}
• {"endpoint_text":"- Change from baseline in DiSSA joint pain item at week 48","definition_or_measurement_approach":"Change from baseline measured on the DiSSA joint pain item at Week 48."}
• {"endpoint_text":"- Change from baseline in DiSSA total score at week 48","definition_or_measurement_approach":"Change from baseline measured by the total DiSSA score at Week 48."}
• {"endpoint_text":"- Change from baseline in DiSSA sicca domain at week 48","definition_or_measurement_approach":"Change from baseline measured in the DiSSA sicca domain at Week 48."}
• {"endpoint_text":"- Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48","definition_or_measurement_approach":"Proportion of participants achieving MCII in ESSDAI, defined as an improvement of ≥3 points, at Week 48."}
• {"endpoint_text":"- Change from baseline in clinESSDAI score at week 24","definition_or_measurement_approach":"Change from baseline measured using the clinESSDAI score at Week 24."}

Methods

• Online advertisements — Banner Ads (e.g., K2_Recruitment Material_Banner Ads; country-specific versions exist such as Ireland V01 IRL en). Channel: web banner ads; target: potential patient population/public in participating country (example: Ireland).
• Online advertisements — Social media clinical trial posts (K2 Online Advertisements_Social Media_Clinical Trial Posts). Channel: social media; target: potential patients/clinical community.
• Physician / Doctor-to-Patient letters (K2_Dr-to-Patient Letter) distributed to clinicians for forwarding to patients.
• Physician referral brochures / letters (Physician Referral Brochure / Letter) for HCP-to-HCP / HCP-to-patient referral.
• Patient advocacy group letters (K2_Patient Advocacy Group Letter) used to engage patient organisations.
• Patient posters and brochures (K1_Patient Poster, K2_Patient Brochure) for site and community distribution.
• ePR Participant Journey Emails / Participant Journey Emails (K2 ePR Participant Journey Emails) — email communications to engaged/potential participants.
• Patient pre-screening website content / Patient pre-screening website (K2_Patient Pre-screening Website Content) — online pre-screening for potential participants.

Primary sponsor

Full Name

Argenx

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Pharmaceutical Product Development LLC (PPD)

Responsibilities

sponsorDuties codes: [4]

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: [1,10,11,12,13,2,3,5,6,8,9]

Name

IQVIA RDS Hellas Single Member S.A.

Responsibilities

sponsorDuties codes: [1,12]

Name

Icon Development Solutions LLC

Responsibilities

sponsorDuties codes: [4]

Third parties

• {"country":"United States","full_name":"Sjoegren'S Foundation Inc.","duties_or_roles":"Managing of ESSDAI training","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,10,11,12,13,2,3,5,6,8,9]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: [1,12]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel / compensation and reimbursement (sponsorDuties code 15, value: \"Patient travel / compensation and reimbursement\")","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited (secondary entry)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}