A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Mode… (NCT06245408) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
United States, Argentina, Australia434 participantsStarted 2024-04-08
Plain-language summary
Primary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state
Secondary Objectives:
1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
. Have an ESSPRI score of ≥ 5 at screening.
. Have an ESSDAI score of \< 5 at screening.
. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min.
. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
. Meets all of the following tuberculosis (TB) criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in ESSPRI score
Timeframe: At Week 48
2
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
Exclusion criteria
. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
. Active malignancy or history of malignancy within the last 5 years, except as follows:
. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR
. Cutaneous basal cell carcinoma following presumed curative therapy.
. Individuals who are pregnant or lactating or planning to become pregnant during the study.
. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.