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Completed

NCT Number: NCT06588296

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

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Body Weight Bone Diseases Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psoriasis Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Reumatologico Caguas, Caguas, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ixekizumab

Drug

Administered SC

Other names: LY2439821

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

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

    Time frame: 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:

    • Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
    • Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
    • Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
    • Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
    • Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)

Secondary outcomes

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

    Time frame: 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:

    • Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
    • Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
    • Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
    • Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
    • Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)

  2. Percentage of Participants Achieving ACR50

    Time frame: 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:

    • Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
    • Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
    • Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
    • Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
    • Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)

  3. Percentage of Participants Achieving at Least a 10% Weight Reduction

    Time frame: Baseline up to Week 36

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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)

Acronym: TOGETHER-PsA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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