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

Phase 3

Active, not recruiting

• Conditions: Psoriatic Arthritis; Obesity
• Interventions: Drug: Ixekizumab; Drug: Tirzepatide

• Registration Number: NCT06588296
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Study Start: 2024-09-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-04
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ixekizumab and Tirzepatide	Ixekizumab	Ixekizumab concomitantly administered with tirzepatide SC.
Ixekizumab	Ixekizumab	Ixekizumab administered subcutaneous (SC).
Ixekizumab and Tirzepatide	Tirzepatide	Ixekizumab concomitantly administered with tirzepatide SC.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction	Baseline up to Week 36	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)
Percentage of Participants Achieving ACR50	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 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)
Percentage of Participants Achieving at Least a 10% Weight Reduction	Baseline up to Week 36	Percentage of Participants Who Achieved at Least a 10% Weight Reduction

Trial Locations

Locations (84)

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

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa; 🇺🇸 Mesa, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV; 🇺🇸 Phoenix, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City; 🇺🇸 Sun City, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson; 🇺🇸 Tucson, Arizona, United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast; 🇺🇸 Tucson, Arizona, United States

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