CTRI/2023/06/053784已完成3 期
A Single-Arm, Multi-Centric Study to Evaluate Efficacy, Safety and Immunogenicity of Tildrakizumab in Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
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
入选标准
- •1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent in accordance with the applicable guidelines.
- •2. Patient must be at least 18 years of age of either gender
- •3. Diagnosis of plaque psoriasis
- •4. Psoriasis Area and Severity Index score more than or equal to 12 at screening and baseline.
- •5. Physicians Global Assessment of at least moderate disease at screening and baseline.
- •6. Has no history of untreated latent or active TB prior to Screening. Has no signs or symptoms suggestive of active TB upon medical history and or physical examination.
- •7. Patients with abnormal clinical laboratory tests
- •8. Patient must have results of a physical examination within normal limits or clinically acceptable limits to the investigator prior to the first dose of study medication.
- •9. Patient is unlikely to conceive, as indicated by at least one yes answer to the following questions a) Patient is a male.
- •b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female more than or equal to 45 years of age with more than 1 year since last menses. d) Female patient of childbearing potential (not fulfilling above criteria b and c), agree to use highly effective methods of contraception to prevent pregnancy during the study (such contraception may include hormonal birth control eg combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence).
- •11. For a woman of childbearing potential, a negative urine pregnancy test at Screening and enrolment.
排除标准
- •1. Presence of predominantly non plaque forms of psoriasis
- •2. Patient who is expected to require topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
- •3. Presence of any infection or history of recurrent infection or severe infection (e.g. pneumonia, cellulitis, bone or joint infections).
- •4. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
- •5. Patients with history of positive test results for HIV, HBsAG, or HCV.
- •6. Patient who is currently participating in another interventional clinical trial or has participated in an interventional clinical trial within 4 weeks prior to Screening.
- •7. Patient or his or her family member is among the personnel of the investigational site or Sponsor or designee staff directly involved with this trial.
- •8. Within 6 months prior to Screening, any significant organ dysfunction or clinically significant laboratory abnormalities that place the patient at unacceptable risk for participation in a trial of an immunomodulatory therapy in the judgment of the investigator.
- •9. Hospitalization due to an acute cardiovascular event, cardiovascular illness, or cardiovascular surgery within 6 months of screening.
- •10. Patient who has sustained, uncontrolled hypertension or uncontrolled diabetes.
- •11. Patient who, in the opinion of the investigator, will not be able to participate optimally in the trial.
- •12. Patient who, in the opinion of the investigator, has a history of alcohol or drug abuse in the previous year.
- •13. Patient with any previous use of tildrakizumab or other interleukin (IL) 23/T helper 17 cells (Th17) pathway inhibitors, including p40, p19 and IL-17 antagonists.
- •14. Patient who has received any treatment listed below within the indicated period prior to enrolment.
研究者
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