EUCTR2019-002713-19-HU进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects with Sjögren’s Syndrome (SS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 174
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Population #1:
- •1. Adults, 18 years or older at time of informed consent (the minimum age for adult participants can be higher than 18 years in countries with different regulations).
- •2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
- •3. Have an ESSDAI score of = 5 at screening; the following domains will be scored but they will not contribute to the minimum ESSDAI score of 5 required for inclusion: Peripheral nervous system, Central nervous system, and Pulmonary.
- •4. Positive for either anti-Ro autoantibodies or 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 is 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 pa
排除标准
- •Populations #1 and #2:
- •1. Patients with medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the ICF.
- •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 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 oral candidiasis, vaginal candidiasis, and cutaneous fungal infections.
- •b. Active viral, bacterial or other infections 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 signing the ICF.
- •c. Epidemiologic risk of COVID-19 (recent exposures, high-risk housing) and for health-related risk of COVID-19 severity based on current understanding of risk factors for severe disease when making a decision regarding the individual subject’s risk of participation. Subjects who have active COVID-19 infection or disease or other significant infection, or, in the judgment of the investigator, who may be at unacceptable risk of COVID-19 or its complications should not be randomized.
- •d. A documented positive SARS-CoV-2 test within 2 weeks prior to randomization. Subjects with a positive test for SARS-CoV-2 may be rescreened at least 2 weeks after a positive test if asymptomatic and at least 3 weeks after symptomatic COVID-19 illness.
- •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 intra-articular) or treatment with > 10 mg/day dose oral prednisone or equivalent wit
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus ErythematosusEUCTR2020-005528-12-ESViela Bio, Inc.195
进行中（未招募）
1 期
A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.Systemic Lupus ErythematosusEUCTR2017-001203-79-DEBristol-Myers Squibb International Corporation360
进行中（未招募）
1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseCrohn's DiseaseEUCTR2017-001976-48-ROBristol-Myers Squibb international Corporation144
进行中（未招募）
1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)EUCTR2020-003140-83-CZeurocrine Biosciences, Inc.60
进行中（未招募）
1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseCrohn's DiseaseEUCTR2017-001976-48-DKBristol-Myers Squibb International Corporation240