Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06864026

A Phase 4, Open-Label Study Evaluating Tirzepatide Added to Ixekizumab in Adults With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice

Led by Eli Lilly and Company · Updated on 2026-02-10

200

Participants Needed

55

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab treatment in adults with active psoriatic arthritis who are overweight or have obesity along with at least one weight-related health condition. This study is a Phase 4, open-label, single-arm trial conducted in real-world clinical practice and will last up to 12 months. The main goal is to see how well this combination improves physical function and helps with weight loss. Participants will continue their current ixekizumab therapy and begin taking tirzepatide by subcutaneous injection according to the approved label. The study involves a single treatment group receiving this combination, and treatment starts within 30 days of deciding to add tirzepatide. The study duration is one year, during which participants are monitored for health outcomes and treatment effects. During the study, participants will have regular assessments including joint counts, skin condition measurements, pain and disease activity ratings, fatigue evaluations, and quality of life surveys. Researchers will measure improvements in functioning and weight loss at 6 and 12 months. Safety and health will be monitored throughout. The total participation time is up to 12 months from starting tirzepatide.

CONDITIONS

Brief Title

A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of active psoriatic arthritis by a rheumatologist or experienced healthcare professional
  • Body Mass Index (BMI) of 30 kg/m2 or greater, or 27 to less than 30 kg/m2 with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease)
  • Treated with ixekizumab for approximately 3 months (±1 month) before deciding to add tirzepatide
  • Able to start tirzepatide within 30 days of the treatment decision
Not Eligible

You will not qualify if you...

  • Currently treated with ixekizumab for less than 2 months or more than 4 months
  • Prior exposure to tirzepatide or other GLP-1 receptor agonists (e.g., dulaglutide, liraglutide, semaglutide)
  • Enrolled in another clinical study
  • Known hypersensitivity to any component of tirzepatide
  • Personal or family history of medullary thyroid cancer
  • Diagnosis of multiple endocrine neoplasia type 2
  • Type 1 diabetes mellitus
  • History of chronic or acute pancreatitis
  • History of diabetic retinopathy requiring acute treatment
  • History of ketoacidosis or hyperosmolar state/coma
  • Severe hypoglycemia unawareness within 6 months before screening
  • Severe gastrointestinal complications including gastroparesis, reflux disease, dyspepsia, or chronic nausea/vomiting

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive tirzepatide administered subcutaneously in addition to continuing ixekizumab as prescribed.

Visits at baseline, Month 6, and Month 12

Trial Site Locations

Total: 55 locations

1

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States, 85392

Actively Recruiting

2

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States, 85225

Actively Recruiting

3

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States, 86001

Actively Recruiting

4

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States, 85297

Actively Recruiting

5

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States, 85306

Actively Recruiting

6

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States, 85210

Actively Recruiting

7

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

Phoenix, Arizona, United States, 85032

Actively Recruiting

8

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

Sun City, Arizona, United States, 85351

Actively Recruiting

9

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, United States, 85704

Actively Recruiting

10

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

Tucson, Arizona, United States, 85748

Actively Recruiting

11

Medvin Clinical Research - Apple Valley

Apple Valley, California, United States, 92307

Actively Recruiting

12

Medvin Clinical Research - Covina

Covina, California, United States, 91722

Actively Recruiting

13

Newport Huntington Medical Group

Huntington Beach, California, United States, 92648

Actively Recruiting

14

Purushotham & Akther Kotha MD, Inc

La Mesa, California, United States, 91942

Actively Recruiting

15

Medvin Clinical Research - Riverside

Riverside, California, United States, 92508

Actively Recruiting

16

Rheumatology Center of San Diego

San Diego, California, United States, 92128

Actively Recruiting

17

Providence Saint John's Medical Foundation

Santa Monica, California, United States, 90404

Actively Recruiting

18

Medvin Clinical Research - Temecula

Temecula, California, United States, 92592

Actively Recruiting

19

Medvin Clinical Research - Tujunga

Tujunga, California, United States, 91042

Actively Recruiting

20

Medvin Clinical Research - Whittier

Whittier, California, United States, 90602

Actively Recruiting

21

Vida Clinical Research

Kissimmee, Florida, United States, 34741

Actively Recruiting

22

Life Clinical Trials

Margate, Florida, United States, 33063

Actively Recruiting

23

CZ Rheumatology

Miami Beach, Florida, United States, 33140

Actively Recruiting

24

Vitalia Medical Research

Palm Beach Gardens, Florida, United States, 33410

Actively Recruiting

25

International Center for Research

Tampa, Florida, United States, 33614

Actively Recruiting

26

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States, 30060

Actively Recruiting

27

Satilla Rheumatology & Internal Medicine

Waycross, Georgia, United States, 31501

Actively Recruiting

28

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States, 60640

Actively Recruiting

29

Greater Chicago Specialty Physicians

Schaumburg, Illinois, United States, 60195

Actively Recruiting

30

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States, 60076

Actively Recruiting

31

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States, 60527

Actively Recruiting

32

Lake Cumberland Rheumatology

New Albany, Indiana, United States, 47150

Actively Recruiting

33

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States, 70605

Actively Recruiting

34

Klein & Associates, M.D., P.A.

Cumberland, Maryland, United States, 21502

Actively Recruiting

35

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, United States, 21740

Actively Recruiting

36

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States, 48081

Actively Recruiting

37

Logan Health Rheumatology

Kalispell, Montana, United States, 59901

Actively Recruiting

38

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

39

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, United States, 28144

Actively Recruiting

40

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States, 44130

Actively Recruiting

41

Essential Medical Research

Tulsa, Oklahoma, United States, 74137

Actively Recruiting

42

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

Actively Recruiting

43

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, United States, 37128

Actively Recruiting

44

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, United States, 76034

Actively Recruiting

45

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth

Fort Worth, Texas, United States, 76109

Actively Recruiting

46

Accurate Clinical Research, Inc

Houston, Texas, United States, 77089

Actively Recruiting

47

Research Physicians Network, LLC

Houston, Texas, United States, 77089

Actively Recruiting

48

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving

Irving, Texas, United States, 75039

Actively Recruiting

49

Biopharma Informatic, LLC

Katy, Texas, United States, 77494

Actively Recruiting

50

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States, 77382

Actively Recruiting

51

DM Clinical Research - TRA

Tomball, Texas, United States, 77375

Actively Recruiting

52

Seattle Rheumatology Associates PLLC

Seattle, Washington, United States, 98104

Actively Recruiting

53

Arthritis Northwest, PLLC

Spokane Valley, Washington, United States, 99216

Actively Recruiting

54

Reuviva Research Center

Guaynabo, Puerto Rico, 00968

Actively Recruiting

55

CMRC Headlands, LLC

San Juan, Puerto Rico, 00918

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

P

Physicians interested in becoming principal investigators please contact

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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