Sjogren Syndrome
Conditions
Interventions
Participants will be randomized (1:1:1) to dazodalibep Dose 1, dazodalibep Dose 2, or placebo as follows:
1.Experimental: dazodalibep Dose 1
Participants will be administered dose 1 of dazodalibep by
Sponsors
Kawada Ayaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: 1.Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria 2.Have an ESSPRI score of >= 5 at screening despite current or prior symptomatic or local therapy. 3.Have an ESSDAI score of 0.1 mL/min. 6.Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 4 weeks prior to randomization unless participant refuses vaccination. 7.Meets all of the following tuberculosis (TB) criteria: A)No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment. B)No signs or symptoms suggestive of active TB from medical history or physical examination. C)No recent (= 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor). D)Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded. E)A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1.Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening. 2.History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis. 3.Active malignancy or history of malignancy within the last 5 years, except as follows: A)In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening: OR B)Cutaneous basal cell carcinoma following presumed curative therapy. 4.Individuals who are pregnant or lactating or planning to become pregnant during the study. 5.Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy. 6.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. 7.Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection. 8.Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization. 9.Individuals with: A)A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. B)Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in DASPRI score or ESSPRI score at Week 48 | — |
Countries
Asia-Pacific region, Europe, Japan, North, Central and South America
Contacts
Public ContactAyaka Kawada
CMIC Co., Ltd.
Outcome results
None listed