Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 144
- 主要终点
- Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
研究概览
简要总结
The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab.
Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
- •Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥
- •Have ≥10% body surface area (BSA) involvement.
- •Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to <30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).
排除标准
- •Medical Conditions
- •Have Type 1 Diabetes Mellitus (T1DM).
- •Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
- •Have a prior or planned surgical treatment for obesity.
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type
- •Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
- •Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:
- •basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
- •cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
- •Have serious disorder or illness other than PsO.
- •Have a history of chronic or acute pancreatitis.
- •Have any prior use of ixekizumab or tirzepatide.
- •Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.
研究组 & 干预措施
Ixekizumab
Ixekizumab administered subcutaneous (SC).
干预措施: Ixekizumab (Drug)
Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
干预措施: Ixekizumab (Drug)
Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
时间窗: Baseline to Week 36
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI score compared to baseline.
次要结局
- Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction(Baseline to Week 36)
- Percentage of Participants Achieving PASI 100(Baseline to Week 36)
- Percentage of Participants Achieving At Least 10% Weight Reduction(Baseline to Week 36)