Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Eli Lilly and Company279 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

279

Conditions

Psoriatic Arthritis Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: 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 2. * 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.

Locations (86)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction

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)

Time frame: Baseline up to Week 36

Secondary Outcomes

Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction

ACR20 is defined as at least 20% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 20% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 20% 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)

Time frame: Baseline up to Week 36

Percentage of Participants Achieving ACR50

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 TJC (0-68) and 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)

Time frame: Baseline up to Week 36

Percentage of Participants Achieving at Least a 10% Weight Reduction

Percentage of Participants Who Achieved at Least a 10% Weight Reduction

Time frame: Baseline up to Week 36