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Alliance for Multispecialty Research, LLC | AMR Wichita East, KS

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Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight (TOGETHER-PsA)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Obesity
Psoriatic Arthritis

Treatments

Drug: Tirzepatide
Drug: Ixekizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06588296
27241
I1F-MC-RHDB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 a body mass index (BMI) greater or equal to ≥27 kilograms per meter squared (kg/m²).

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 or cervical carcinoma in situ.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Ixekizumab
Experimental group
Description:
Ixekizumab administered subcutaneous (SC).
Treatment:
Drug: Ixekizumab
Ixekizumab and Tirzepatide
Experimental group
Description:
Ixekizumab concomitantly administered with tirzepatide SC.
Treatment:
Drug: Ixekizumab
Drug: Tirzepatide

Trial contacts and locations

90

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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