None listed
Conditions
Interventions
The study will enroll 2 SS populations. Population #1 will be composed of subjects with moderate to severe systemic disease activity defined by ESSDAI ≥
5. Population #2 will be composed of subjects with mild systemic disease activity defined by ESSDAI score < 5 but with moderate to severe subjective symptoms defined by ESSPRI score ≥
5 and residual stimulated salivary flow. Type of group
VIB4920 is formulated at 100 mg/mL VIB4920 in 10 mM sodium phosphate buffer, 250 mM sucrose, 0.02% (weight/volume [w/v]) poloxamer 188, pH 7.4. The nominal volume in each vial is 5.0 mL. VIB4920 is a sterile liquid Drug Product (500 mg VIB4920 per vial, nominal) intended for IV infusion following dilution in normal saline.
VIB4920 is supplied as a sterile liquid in a 6R glass vial at a nominal fill volume of 5.0 mL, stoppered with 20 mm Teflon-coated elastomeric stopper, and sealed with flip
Sponsors
Horizon Therapeutics Ireland DAC,
Eligibility
Inclusion criteria
Inclusion criteria: 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, as per the definition of the standard central laboratory test. 5. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, European Union [EU] Data Privacy Directive in the EU) 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. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. 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. 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 0.1 mL/min. 7. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, EU Data Privacy Directive in the EU) 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. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. 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.
Exclusion criteria
Exclusion criteria: Population 1: 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 (eg, immobilization or major surgery within 12 weeks before screening), prothrombotic status (including, but not limited to, congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of catastrophic antiphospholipid syndrome). 3. Patients requiring treatment with anticoagulant drugs (clopidogrel, prasugrel, warfarin, low molecular weight heparin, others). Low-dose aspirin treatment (up to 325 mg/day) is allowed. 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. Population 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 (eg, immobilization or major surgery within 12 weeks before screening), prothrombotic status (including, but not limited to, congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of catastrophic antiphospholipid syndrome). 3. Patients requiring treatment with anticoagulant drugs (clopidogrel, prasugrel, warfarin, low molecular weight heparin, etc). Low-dose aspirin treatment (up to 325 mg/day) is allowed. 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 treated with apparent success with curative therapy 6. Subjects who are pregnant or lactating or planning to get pregnant during the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Population #1: The primary efficacy endpoint of change from baseline to Day 169 in ESSDAI score will be analyzed using the mixed-effect model for repeated measures (MMRM) approach based on the FAS. Population #2: The primary efficacy endpoint of change from baseline to Day 169 in ESSPRI score will be analyzed using the MMRM approach based on the FAS Measure:Analysis of the Primary Efficacy Endpoint Primary efficacy analyses: Timepoints:Population #1: The primary efficacy endpoint of change from baseline to Day 169. Population #2: The primary efficacy endpoint of change from baseline to Day 169. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The categorical secondary efficacy endpoints of Population #1 and Population #2 will be analyzed using a logistic regression model based on the FAS. The continuous secondary efficacy endpoints of Population #1 and Population #2 will be analyzed using the MMRM approach based on the FAS. Measure:Analysis of Secondary Efficacy Endpoints Timepoints:The categorical secondary efficacy endpoints of Population #1 and Population #2 will be analyzed using a logistic regression model based on the FAS. The continuous secondary efficacy endpoints of Population #1 and Population #2 will be analyzed using the MMRM approach based on the FAS. | — |
Countries
Argentina, China, France, Germany, Greece, India, Italy, Nederland, Peru, Poland, Spain, Turkey, United Kindgdom, United States
Contacts
Public Contactangela Flores
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed