NCT05855967已完成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
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24
研究概览
简要总结
The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants:
- •Male or nonpregnant, nonbreastfeeding female participants.
- •For PsO Participants:
- •Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline
- •Have ≥10% Body Surface Area (BSA) of psoriasis at screening (Visit 1) and baseline
- •Have both an static Physician's Global Assessment (sPGA) score of ≥3 and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline
- •For PsA Participants
- •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.
- •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.
- •Presence of active PsO or a documented history of psoriasis.
排除标准
- •Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.
- •Have a history of drug-induced PsO.
- •Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
- •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
- •Have diagnosis or history of malignant disease within the 5 years prior to baseline
- •Have any other active or recent infection within 4 weeks of baseline
- •For PsO Participants:
- •Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)
- •Have pustular, erythrodermic, and/or guttate forms of PsO
- •Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).
- •Have allergy to rubber or latex.
- •For PsA Participants:
- •Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than methotrexate (MTX), leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline
- •Have received treatment with interleukin (IL)17 or IL-12/23 targeted Mab therapy
- •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-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4 inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab.
- •Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.
研究组 & 干预措施
Ixekizumab - PsO With no Active PsA
Experimental
Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
- Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by;
- Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10
- Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20
干预措施: Ixekizumab (Drug)
Ixekizumab - Active PsA
Experimental
Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received:
- Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by;
- Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10
- Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20
Participants with active PsA without moderate to severe PsO received:
- Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by
- Ixekizumab 80 mg SC injection Q4W at Week 4, 8, 12, 16, and 20.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24
时间窗: Week 0 to Week 24
* An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect. * TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period.
次要结局
- PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12(Week 12)
- PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal)(Week 12)
- Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24(Week 24)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
3 期
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT02513550Eli Lilly and Company1,257
已完成
3 期
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsoriasisPlaque PsoriasisNCT02561806Eli Lilly and Company302
已完成
4 期
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic ArthritisPsoriatic ArthritisNCT03151551Eli Lilly and Company566
已完成
3 期
A Study in Japanese Participants With Moderate-to-Severe PsoriasisPsoriasisNCT01624233Eli Lilly and Company91
已完成
3 期
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic ArthritisPsoriatic ArthritisNCT02584855Eli Lilly and Company394