CTRI/2023/06/053776进行中（未招募）4 期
A 24-Week Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety of Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis or Active Psoriatic Arthritis in India
Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
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
- •All participants:
- •1. Male or nonpregnant, non-breastfeeding female participants.
- •For PsO Participants:
- •1. Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline
- •2. Have =10% BSA of psoriasis at screening and baseline
- •3. Have both an sPGA score of =3 and PASI score =12 at screening and baseline
- •For PsA Participants
- •1. Have a diagnosis of active PsA for at least 6 months (based on a detailed medical history provided by the patient, and a physical exam by the Study Investigator, and/or other evidence such as that provided by joint x-rays, that establishes a history consistent with a diagnosis of active PsA of at least 6 months’ duration) and currently meet the Classification for PsA (CASPAR) criteria.
- •2. Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints, as determined by the Tender and Swollen Joint Count Assessment Form at screening and baseline.
- •3. Presence of active PsO or a documented history of psoriasis.
排除标准
- •All participants:
- •1. Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.
- •2. Have a history of drug induced PsO.
- •3. Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
- •4. Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or will require such during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
- •5. Have diagnosis or history of malignant disease within the 5 years prior to baseline
- •6. Have any other active or recent infection within 4 weeks of baseline
- •For PsO Participants:
- •1. Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)
- •2. Have pustular, erythrodermic, and/or guttate forms of PsO
- •3. Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).
- •4. Have allergy to rubber or latex.
- •For PsA Participants:
- •1. Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than MTX, leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline
- •2. Have received treatment with IL-17 or IL12/23 targeted Mab therapy
- •3. Are currently receiving treatment with any biologic or small molecule therapy for PsA or PsO, including investigational therapies (such as, but not limited to, a tumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor, anti-IL-12/23p40, T cell or B cell targeted therapies, phosphodiesterase [PDE] 4 inhibitors, or Janus kinase [JAK] inhibitors), or have received denosumab.
- •4. Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.
研究者
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