EUCTR2016-004258-14-GB进行中（未招募）1 期
A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome. - GSK2618960, PH2a, 2-part, repeat IV dose, Immunogenecity, Safety and PK/PD Study in pSS pts
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99,999
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
入选标准
- •Inclusion Criteria (Part I)
- •A participant will be eligible for inclusion in this study only if all of the following criteria
- •1. Between 18 and 70 years of age at the time of signing the informed consent.
- •TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- •2. Diagnosis of primary Sjögren’s Syndrome according to the American-European
- •Consensus Group criteria (Vitali, 2002).
- •3. Documented previous biopsy evidence of salivary gland inflammation consistent with pSS and/or documented history of anti-Ro (SSA) and/or anti-La (SSB) antibodies.
- •4. Male and female participants
- •Male participants
- •Males with FRP partners must agree to utilize two forms of complementary contraception consisting of one barrier method (male condom or female
- •diaphragm) and one method from one of the options listed in the Modified List
- •of Highly Effective Methods for Avoiding Pregnancy in FRP (see Appendix 5) from start of screening until 6 months after termination of MTX administration.
- •Female participants, where one of the following conditions apply:
- •a. Non reproductive potential as defined as:
- •i. pre-menopausal females with one of the following:
- •-documented tubal ligation
- •-documented hysteroscopic tubal occlusion
- •-procedure with followup confirmation of bilateral tubal occlusion
- •-hysterectomy
- •-documented bilateral oophorectomy
- •ii. post-menopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating
- •hormone (FSH) > 40 million international unit (MIU)/mL and oestradiol < 40 picogram (pg)/mL (< 140 picomol (pmol)/L) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal
- •status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation
- •of their postmenopausal status, they can resume use of HRT during the study.
- •b. Reproductive potential with:
- •- negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening, AND a negative urine pregnancy test on the first day of MTX run-in phase prior to administration, AND during MTX run in phase as per routine monitoring in the MTX label AND negative urine pregnancy test on Day 1 prior to administration of GSK2618960 (or placebo).
- •- agrees to utilize two forms of complementary contraception consisting of one barrier method (male condom or female diaphragm) and one method from one of the options listed in the Modified List of Highly
- •Effective Methods for Avoiding Pregnancy in FRP (see Appendix 5) from start of screening until 6 months after termination of MTX administration.
- •Those participants that were on MTX therapy prior to enrolling into the study, and that were using consistently one contraception method from the list of
排除标准
- •Exclusion Criteria (Part I)
- •A participant will not be eligible for inclusion in this study if any of the following criteria
- •CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL)
- •1. Diagnosis of Sjögren’s syndrome (SS) associated with other immune-mediated disorders, including rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, IgG4 or Graft versus Host disease.
- •2. Any history of the following systemic manifestations of primary Sjögren’s syndrome: vasculitis, central nervous system (CNS).
- •3. Contraindications to MTX according to SPC.
- •4. Any history of acute renal failure, tubulointerstitial nephritis, glomerulonephritis or presence of chronic kidney disease.
- •Patients with history of distal tubular acidosis are allowed, provided the patients are asymptomatic at the time of screening, MTX run-in period and baseline.
- •5. Any history of lymphoma or fixed unilateral or bilateral parotid gland swelling suggestive of lymphoma.
- •6. Monoclonal gammopathy as defined by: IgA or IgM monoclonal gammopathy, or abnormal Free Light Chain ratio, or serum M-protein>20 g/L.
- •7. Previous major organ transplant or haematopoietic stem cell transplantation.
- •8. Previous head or neck irradiation.
- •9. Leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence
- •of metastatic disease for 3 years
- •10. Breast cancer within the past 10 years.
- •11. Positive serology for:
- •-Hepatitis C (HCV) or presence of HCV ribonucleic acid (RNA)
- •-Hepatitis B (HB), defined as HB surface antigen positive (HBsAg+) OR HB core antibody positive (HBcAb+)
- •12. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and TB testing: either a positive tuberculin skin test (TST; defined as a skin induration <5 mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) QuantiFERON-TB Gold test.
- •Note: The choice to perform a TST or a QuantiFERON-TB Gold test will be made by the investigator according to local licensing and standard of care. The QuantiFERON-TB
- •Gold test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosupression.
- •13. Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows:
- •a. Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes
- •zoster and atypical mycobacteria). OR
- •b. Discharged from hospitalization for treatment of infection within 30 days of screening.
- •c. Use of parenteral (IV or intramuscular [IM])antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) wit
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