A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren's Syndrome (SS)
- Conditions
- Sjögren's syndromeMedDRA version: 21.1Level: LLTClassification code 10059142Term: Sjoegren's syndromeSystem Organ Class: 100000004859Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2019-002713-19-IT
- Lead Sponsor
- VIELABIO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 174
Pop #1:
1. Adults, 18yy or older at time of Inf.Consent.(the min age for adult particip can be >18yy in countries with different regul).
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classif Criteria
3. ESSDAI score of = 5 at screening; the following domains will be scored but will not contribute to the min ESSDAI score of 5 required for incl: Periph nerv system, Centr nerv system, and Pulmonary
4. Pos for either anti-Ro autoantibodies or RF, or both at screening
5. Written inf consent and any locally required authoriz. obtained from the subject/legal rep prior to performing any protocol-related proced, including screening evaluations
6. FCBP who are sexually active with a nonsterilized male partner must use a highly effective method of contrac from signing the ICF and must agree to continue using such precautions through the end of the study F-U; cessation of contrac. after this point should be discussed with a resp physician. A recommend that the female partners (of CB potential) of male study particip should use a highly effective method of contrac. other than a barrier method is made
7. Nonsterilized male subjects who are sexually active with a female partner of CB potential must use a condom with spermicide from D1 through the end of the study
8. Meets all of the following TB criteria:
a. No history of latent or active TB prior to screening, with the exception of latent TB with documented completion of appropriate treatment
b. No signs or symptoms suggestive of active TB from medical history or physical examin
c. No recent (= 12w of screening) close contact with a person with active TB
d. Neg IGRA test result for TB obtained within 12 weeks prior to randomiz. Subjects with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded
e. Chest radiograph (obtained during the screening period or any time within 12w prior to signing of the ICF) with no evidence of current active TB or other infection, or old active TB, malignancy, or clinically signif abnormalities suggesting an active process (unless due to SS)
Pop #2:
1. Male or female adults, 18yy old or older at time of inf consent
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classif Criteria
3. ESSPRI score of = 5 at screening
4. ESSDAI score of < 5 at screening
5. Pos for either anti-Ro autoantibodies or RF, or both at screening
6. Residual salivary gland function as defined by whole stimulated salivary flow >0.1 mL/min
7. Written inf consent and any locally required obtained from the subject/legal rep prior to performing any protocol-related proced, including screening evaluations
8. FCBP who are sexually active with a nonsterilized male partner must use a highly effective method of contrac from signing the ICF, and must agree to continue using such precautions through the end of the F-U; cessation of contrac after this point should be discussed with a resp physician. A recommend that the female partners (of CB potential) of male study particip should use a highly effective method of contrac other than a barrier method will be made
9. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from D1 through to the end of the study
10. Meets all of the following TB criteria:
a. No history of latent or active TB prior to screening, with the exception of latent TB with documented completion of appropriate treatment
b. No signs or symptoms sugg
Please refer to the study Protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method