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 States434 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 range18 Years
SexALL
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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:
✓. 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
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
✕. 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.