Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 170
- 主要终点
- Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
研究概览
简要总结
The main purpose of this study is to demonstrate that when participants with psoriatic arthritis 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 psoriatic arthritis 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
- •Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
- •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 a serious disorder or illness other than PsA.
- •Have a history of chronic or acute pancreatitis.
- •Have any prior use of ixekizumab or tirzepatide.
- •Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
- •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: Tirzepatide (Drug)
Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
时间窗: Baseline up to Week 36
ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments: 1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) 2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \_NRS) 3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS) 4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or 5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
时间窗: Baseline up to Week 36
ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments: 1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) 2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \_NRS) 3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS) 4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or 5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
次要结局
- Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction(Baseline up to Week 36)
- Percentage of Participants Achieving ACR50(Baseline up to Week 36)
- Percentage of Participants Achieving at Least a 10% Weight Reduction(Baseline up to Week 36)
- Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction(Baseline up to Week 36)
- Percentage of Participants Achieving ACR50(Baseline up to Week 36)
- Percentage of Participants Achieving at Least a 10% Weight Reduction(Baseline up to Week 36)