A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)
- Conditions
- Sjögren's syndromeTherapeutic area: Body processes [G] - Immune system processes [G12]MedDRA version: 21.1Level: LLTClassification code 10059142Term: Sjoegren's syndromeSystem Organ Class: 100000004859
- Registration Number
- EUCTR2019-002713-19-PL
- Lead Sponsor
- Viela Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 174
Population #1:
1. Male or female adults, 18 years or older at time of informed consent.
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
3. Have an ESSDAI score of = 5 at screening; the following domains are excluded and will not be scored: Peripheral nervous system, Central nervous system, and Pulmonary.
4. Positive for either anti-Ro autoantibodies, RF, or both at screening.
5. Written informed consent and any locally required authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from signing the informed consent form (ICF), and must agree to continue using such precautions through the end of the study follow-up; cessation of contraception after this point should be discussed with a responsible physician. A recommendation that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method will be made.
7. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through the end of the study.
8. Meets all of the following tuberculosis (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 examination.
c. No recent (= 12 weeks of screening) close contact with a person with active TB.
d. Negative Interferon Gamma Release Assay (IGRA) test result for TB obtained within 12 weeks prior to randomization. Subjects 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 signing of the ICF) with no evidence of current active TB or other infection, or old active TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
Population #2:
1. Male or female adults, 18 years old or older at time of informed consent.
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
3. Have an ESSPRI score of = 5 at screening.
4. Have an ESSDAI score of < 5 at screening.
5. Positive 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 informed consent and any locally required obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
8. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from signing the ICF, and must agree to continue using such precautions through the end of the follow up of the study; cessation of contraception after this point should be discussed with a responsible physician. A recommendation that the female partners (of child bearing potential) of male study participants should use a highly effective method of contraception other than a barrier method will be made.
9. Nonsterilized male subjects who are sexually
Populations #1 and #2:
1. Patients with medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of enrollment.
2. Patients with risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
3. Patients requiring treatment with anticoagulant drugs.
4. Concomitant polymyositis or dermatomyositis or systemic sclerosis.
5. Active malignancy or history of malignancy, 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 apparently curative therapy.
6. Subjects who are pregnant or lactating or planning to become pregnant during the duration of the study.
7. Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C, or HIV infection.
8. Subjects who have had more than one episode of herpes zoster and/or an opportunistic infection in the last 12 months, with the exception of oral candidiasis, vaginal candidiasis, and cutaneous fungal infections.
9. Subjects with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
10. Subjects 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 subject at unacceptable risk of complications, interfere with evaluation of the IP or confound the interpretation of subject safety or study results.
11. Subjects who are unable or unwilling to comply with protocol requirements.
12. Subjects who have received live vaccine within the 4 weeks prior to ICF signature.
13. Last administration of experimental biologic or oral agents < 3 months or 5 half-lives before randomization.
14. Subjects who have had previous treatment with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy < 3 months before randomization.
15. Subjects who have received previous treatment with anti-CD40L compounds at any time before screening.
16. Subjects with blood tests, at screening, of any of the following:
• AST > 2 x ULN
• ALT > 2 x ULN
• TBL > 2 x ULN
• Hemoglobin < 75 g/L
• Neutrophils < 1.0 x 109/L
• Platelets < 100 x 109/L
• Prothrombin or PTT > ULN
Population #1:
1. Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization.
2. Subjects treated with systemic corticosteroids for indications other than SS for more than a total of 2 weeks within 24 weeks prior to ICF signature.
3. Use of the following medications:
a. Antimalarials if they have been initiated or if the dose has changed within 8 weeks prior to signing the ICF or during the screening period.
b. MTX, if the dose is > 20 mg/week; or if there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1), or if there has been any change in route of administration.
c. AZA, if the dose is > 150 mg/day and there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1) and any change in route of administration.
d. Leflunomide, if the dose is >20 mg/day; or if there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1).
e. MMF, if the dose is >2g/d
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