NL-OMON53789已完成2 期
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren*s Syndrome - ARGX-113-2106
IQVIA RDS Netherlands B.V.0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply:
- •1. Is at least the legal age of consent for clinical trials when signing the
- •informed consent form
- •2. Is capable of providing signed informed consent, as described in Section
- •10.1.3 of the protocol, and complying with protocol requirements
- •3. Agrees to use contraceptive measures consistent with local regulations and
- •the following:
- •a. Male participants: refer to Section 10.4.2.2 of the protocol.
- •b. WOCBP (defined in Section 10.4.1) must have a negative serum pregnancy test
- •at screening and a negative urine pregnancy test at baseline before receiving
- •IMP. Contraceptive requirements are provided in Section 10.4 of the protocol.
- •4. Meets the following criteria at screening:
- •a. ACR/EULAR 2016 pSS who met criteria <=7 years before screening
- •b. ESSDAI >=5
- •c. Anti Ro/SS-A positive
- •d. Residual salivary flow (UWSF rate >0 and/or SWSF rate >0.10)
排除标准
- •Participants will be excluded from the study if any of the following criteria
- •1. Known autoimmune disease or any medical condition that, in the
- •investigator*s judgment, would interfere with an accurate assessment of
- •clinical symptoms of pSS or puts the participant at undue risk
- •2. History of malignancy unless considered cured by adequate treatment with no
- •evidence of recurrence for >=3 years before the first administration of IMP.
- •Adequately treated participants with the following cancers may be included at
- •a. Basal cell or squamous cell skin cancer
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
- •3. Clinically significant uncontrolled active acute or chronic bacterial,
- •viral, or fungal infection
- •4. Positive serum test at screening for an active infection with any of the
- •a. HBV that is indicative of an acute or chronic infection, unless associated
- •with a negative HBsAg or negative HBV DNA test
- •b. HCV based on HCV antibody assay unless a negative RNA test is available
- •c. HIV based on test results of a CD4 count of <200 cells/mm3 that are
- •associated with an AIDS-defining condition
- •d. HIV based on test results of a CD4 count of *200 cells/mm3 not adequately
- •treated with antiviral therapy
- •5. Clinically significant disease, recent major surgery (within 3 months of
- •screening), or intention to have surgery during the study; or any other medical
- •condition that, in the investigator*s opinion, would confound the results of
- •the study or put the participant at undue risk
- •6. Current participation in another interventional clinical study
- •7. Known hypersensitivity to IMP or 1 of its excipients
- •8. History (within 12 months of screening) of current alcohol, drug, or
- •medication abuse as assessed by the investigator
- •9. Pregnant or lactating state or intention to become pregnant during the study
- •10. Previously participation in an efgartigimod clinical study and treatment
- •with >=1 dose of IMP
- •11. Total IgG of <4 g/L at screening
- •12. Secondary Sjögren*s syndrome overlap syndromes where another confirmed
- •autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid
- •arthritis, systemic lupus erythematosus, scleroderma, inflammatory bowel
- •disease) is the primary diagnosis
- •13. Positive SARS-CoV-2 PCR test at screening
- •14. Any severe systemic pSS manifestation that may put the participant at undue
- •risk based on the investigator*s opinion
- •Note: Medications cited in exclusion criteria 15-22 are also prohibited during
- •the screening period.
- •15. IVIg, SCIg, or PLEX <12 weeks before screening
- •16. Live or live-attenuated vaccine <4 weeks before screening
- •17. Pilocarpine and/or any other pharmacological stimulant for salivary and
- •lacrimal glands
- •that is not at a stable dose in the 4 weeks prior to screening or is started<= 4
- •18. Anticholinergic agents which are not at a stable dose 4 weeks prior to
- •screening or during
- •19. Corticosteroids:
- 另有 4 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Study of the safety and effectiveness of Efgartigimod in Patients with Primary Sjögren’s Syndrome (pSS)EUCTR2021-005911-30-NLargenx BV30
招募中
2 期
Study to Evaluate the Efficacy and Safety of K-808 (pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) TreatmentPrimary Biliary CholangitisJPRN-jRCT2071230106Tanigawa Ryohei45
进行中（未招募）
1 期
Phase-II Study of MK-1029 added to Montelukast in Adults with Uncontrolled Asthma.Persistent asthmaEUCTR2015-005054-36-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc100
进行中（未招募）
不适用
A Phase 2A, Randomized, Placebo-controlled, Parallel group, Multiple-dose study to evaluate the Efficacy, Safety and Tolerability of 12-week oral administration of PF-00734200 tablets to subjects with Type 2 Diabetes Mellitus on stable treatment with Metformin - N/AType 2 Diabetes Mellitus (T2DM)MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2007-001922-28-SEPfizer Inc., 235 East 42nd Street, New York, NY 10017320
进行中（未招募）
不适用
A Phase 2A, Randomized, Placebo-controlled, Parallel group, Multiple-dose study to evaluate the Efficacy, Safety and Tolerability of 12-week oral administration of PF-00734200 tablets to subjects with Type 2 Diabetes Mellitus on stable treatment with Metformin - N/AEUCTR2007-001922-28-DEPfizer Inc., 235 East 42nd Street, New York, NY 10017320