Clinical trial NCT06864026: 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)
Official title: A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriatic Arthritis
Overweight or Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
* Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
* Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.
* Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).

Exclusion Criteria:

* Have currently received ixekizumab for more than 4 months or less than 2 months.
* Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
* Are currently enrolled in any other clinical study.
* Have a known hypersensitivity to any component of tirzepatide.
* Have a personal or family history of medullary thyroid cancer.
* Have multiple endocrine neoplasia type 2.
* Have type 1 diabetes mellitus.
* Have a history of chronic or acute pancreatitis at any time before screening.
* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
* Have a history of ketoacidosis or hyperosmolar state/coma.
* Have a history of severe hypoglycemia unawareness within the 6 months before screening.
* Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Primary outcomes:
measure: Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
timeFrame: 12 Months
measure: Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
timeFrame: Month 6 and Month 12
measure: Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
timeFrame: Month 6 and Month 12
measure: Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
timeFrame: Month 6 and Month 12
measure: Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving a HAQ-DI score ≤0.5
timeFrame: Month 6
measure: Percentage of Participants with ≥10% Weight Loss at Month 6
timeFrame: Month 6
measure: Mean Percent Change of Weight from Baseline
timeFrame: Baseline, Month 6 and Baseline, Month 12
Other outcomes:
Locations:
city: Avondale
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
state: Arizona
city: Chandler
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
state: Arizona
city: Flagstaff
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
state: Arizona
city: Gilbert
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
state: Arizona
city: Glendale
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
state: Arizona
city: Mesa
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
state: Arizona
city: Phoenix
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
state: Arizona
city: Sun City
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
state: Arizona
city: Tucson
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
state: Arizona
city: Tucson
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
state: Arizona
city: Apple Valley
country: United States
facility: Medvin Clinical Research - Apple Valley
state: California
city: Covina
country: United States
facility: Medvin Clinical Research - Covina
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: La Mesa
country: United States
facility: Purushotham & Akther Kotha MD, Inc
state: California
city: Riverside
country: United States
facility: Medvin Clinical Research - Riverside
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Medical Foundation
state: California
city: Temecula
country: United States
facility: Medvin Clinical Research - Temecula
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Whittier
state: California
city: Kissimmee
country: United States
facility: Vida Clinical Research
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials
state: Florida
city: Miami Beach
country: United States
facility: CZ Rheumatology
state: Florida
city: Palm Beach Gardens
country: United States
facility: Vitalia Medical Research
state: Florida
city: Tampa
country: United States
facility: International Center for Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Waycross
country: United States
facility: Satilla Rheumatology & Internal Medicine
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians
state: Illinois
city: Skokie
country: United States
facility: Arnold Arthritis & Rheumatology
state: Illinois
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness PLLC
state: Illinois
city: New Albany
country: United States
facility: Lake Cumberland Rheumatology
state: Indiana
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc
state: Louisiana
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Kalispell
country: United States
facility: Logan Health Rheumatology
state: Montana
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Salisbury
country: United States
facility: Onsite Clinical Solutions, LLC - Brenner Ave
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Murfreesboro
country: United States
facility: AARA Clinical Research - Murfreesboro Medical Clinic
state: Tennessee
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions - Colleyville
state: Texas
city: Fort Worth
country: United States
facility: AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: Houston
country: United States
facility: Research Physicians Network, LLC
state: Texas
city: Irving
country: United States
facility: AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
state: Texas
city: Katy
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Mesquite
country: United States
facility: SouthWest Rheumatology Research, LLC
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston - Woodlands
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - TRA
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Associates PLLC
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Guaynabo
country: Puerto Rico
facility: Reuviva Research Center
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: