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临床试验/PER-050-23
PER-050-23尚未招募3 期

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DAZODALIBEP IN PARTICIPANTS WITH SJÖGREN’S SYNDROME WITH MODERATE-TO-SEVERE SYSTEMIC DISEASE ACTIVITY

Horizon Therapeutics Ireland DAC0 个研究点目标入组 0 人开始时间: 2024年5月27日最近更新:
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适应症

试验速览

阶段
3 期
状态
尚未招募
研究概览入排标准研究者记录与标识符相似试验

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

性别
All

入选标准

  • •To be included in this study, individuals must satisfy all the following criteria:
  • •1.Adults = 18 years at time of informed consent (the minimum age for adult participants may be greater than 18 years of age in accordance with country-specific age definitions for adulthood). Participants must be capable of providing their own informed consent.
  • •2.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 participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • •3.Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria (Section 10.1, Appendix 1). If SS diagnosis based on positive anti-Ro autoantibody, anti-Ro positivity must be confirmed by central lab.
  • •4.Have an ESSDAI score of = 5 despite symptomatic or local therapy at screening. The following domains will be scored, but they will not contribute to the minimum ESSDAI score of 5 required for inclusion as these domains may have lower sensitivity to change over duration of trial: peripheral nervous system, central nervous system, and pulmonary.
  • •5.Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).
  • •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 or 3 months after last IP administration (if participant withdraws from study). Cessation of contraception after this point should be discussed with a responsible physician. The Investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of IP. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and must have a negative urine pregnancy test on the day of dosing prior to each dose of IP. The Investigator is responsible for reviewing the participants medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Highly effective methods of contraception (with a failure rate of < 1% per year when used consistently and correctly).
  • •7.Nonsterilized male participants who are sexually active with a female partner of childbearing potential must use a condom with spermicide (unless spermicide is not available or restricted per local regulations) and refrain from donating fresh unwashed semen from Day 1 through the end of the study. His female partner should also be advised of the benefit to use a highly effective method of contraception, as a condom may break or leak.
  • •8.Vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) according to current local authority guidelines, if any, at least 2 weeks prior to screening unless the participant refuses vaccination. Initial or subsequent coronavirus disease 2019 (COVID-19) vaccine administration is permitted during the study as long as it is not administered during the screening period or within a week after Dose 1; if vaccine is to be admini

排除标准

  • •If an individual meets any of the following criteria, he or she is ineligible for this study:
  • •1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • •2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
  • •3. Active malignancy or history of malignancy within the last 5 years, 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 presumed curative therapy.
  • •4 Individuals who are pregnant or lactating or planning to become pregnant during the study.
  • •5 Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
  • •6 Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.
  • •7 Individuals who, in the opinion of the Investigator, are unable or unwilling to comply with protocol requirements (eg, active drug or alcohol abuse or for other reasons), including the completion of the Diary for Assessing Sjogren’s Patient-Reported Index (DASPRI) diary.
  • •8 Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. A positive test for hepatitis B infection at screening is defined as: (1) positive for hepatitis B surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb). Patients HBsAg negative, hepatitis B surface antibody (HBsAb) positive and HBcAb negative due to vaccination are eligible for the study. Individuals with a positive test for or a history of treatment for hepatitis C are excluded unless they have a documented sustained viral response to antiviral drugs approved for the treatment of hepatitis C, defined as an undetectable viral level of hepatitis C RNA at least 24 weeks following completion of therapy. Individuals with advanced fibrosis or cirrhosis due to hepatitis C should not be enrolled.
  • •9 Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to COVID-19 within 10 days prior to randomization. Individuals with COVID-19 or COVID-19 exposure can delay randomization for 10 days and randomize once recovered; otherwise, they will need to rescreen.
  • •10 Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
  • •11 Last administration of experimental or investigational biologic or oral agents (other than those listed in exclusion criterion 16) < 6 months prior to screening.
  • •12 Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.
  • •13 Injectabl

研究者

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