A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Purpose
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 plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.
Conditions
- Psoriasis
- Overweight or Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant) - Have 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 mellitus, obstructive sleep apnea, or cardiovascular diseases). - Must have initiated treatment 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/screening).
Exclusion Criteria
- Have currently received ixekizumab for more than 4 months or less than 2 months. - Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide. - Are currently enrolled in any other clinical study. Other exclusions - Have a known hypersensitivity to tirzepatide or to any of its component. - Have a personal or family history of medullary thyroid cancer. - Have multiple endocrine neoplasia type 2. - Have type I diabetes mellitus. - Have a history of chronic or acute pancreatitis at any time before screening (Visit 1). - 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 and hypoglycemia unawareness within the 6 months before screening. - Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tirzepatide |
Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label. |
|
Recruiting Locations
Medical Dermatology Specialists
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Contact:
602-354-5770
602-354-5770
First OC Dermatology Research Inc
Fountain Valley, California 92708
Fountain Valley, California 92708
Contact:
714-531-2966
714-531-2966
Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
Fremont, California 94538
Contact:
510-797-0140
510-797-0140
Metropolis Dermatology
Los Angeles, California 90017
Los Angeles, California 90017
Contact:
424-393-0005
424-393-0005
Northridge Clinical Trials
Northridge, California 91325
Northridge, California 91325
Contact:
818-350-7482
818-350-7482
NeoClinical Research
Hialeah, Florida 33016
Hialeah, Florida 33016
Contact:
305-456-9062
305-456-9062
Skin Care Research
Hollywood, Florida 33021
Hollywood, Florida 33021
Contact:
954-674-3535
954-674-3535
Encore Medical Research
Hollywood, Florida 33024
Hollywood, Florida 33024
Contact:
954-400-1725
954-400-1725
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida 33607
Tampa, Florida 33607
Contact:
813-948-7550
813-948-7550
TruDerm & TruSpa
Wellington, Florida 33449
Wellington, Florida 33449
Southeast Research Specialists
Douglasville, Georgia 30135
Douglasville, Georgia 30135
Contact:
678-702-3376
678-702-3376
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
Contact:
317-516-5030
317-516-5030
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
Plainfield, Indiana 46168
Contact:
317-837-6082
317-837-6082
Equity Medical - Bowling Green
Bowling Green, Kentucky 42104
Bowling Green, Kentucky 42104
Contact:
270-213-7777
270-213-7777
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland 20850
Rockville, Maryland 20850
Metro Boston Clinical Partners
Brighton, Massachusetts 02135
Brighton, Massachusetts 02135
David Fivenson, MD, PLC
Ann Arbor, Michigan 48103
Ann Arbor, Michigan 48103
Contact:
734-222-9630
734-222-9630
The Derm Institute of West Michigan
Caledonia, Michigan 49316
Caledonia, Michigan 49316
Contact:
616-326-0114
616-326-0114
Skin Cancer and Dermatology Institute - Reno
Reno, Nevada 89509
Reno, Nevada 89509
Contact:
775-336-3658
775-336-3658
Stracskin
Portsmouth, New Hampshire 03801
Portsmouth, New Hampshire 03801
Contact:
617-833-9995
617-833-9995
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
Care Access - Hoboken
Hoboken, New Jersey 07030
Hoboken, New Jersey 07030
Contact:
551-278-8680
551-278-8680
Equity Medical
New York, New York 10023
New York, New York 10023
Contact:
212-466-6550
212-466-6550
Revival Research Institute, LLC
Cary, North Carolina 27511
Cary, North Carolina 27511
Onsite Clinical Solutions - Huntersville
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Contact:
800-785-3150
800-785-3150
Optima Research - Boardman
Boardman, Ohio 44512
Boardman, Ohio 44512
Contact:
330-422-3234
330-422-3234
Oregon Dermatology and Research Center
Portland, Oregon 97210
Portland, Oregon 97210
Contact:
503-226-3376
503-226-3376
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania 19462
Plymouth Meeting, Pennsylvania 19462
Columbia Dermatology & Aesthetics
Columbia, South Carolina 29212
Columbia, South Carolina 29212
Contact:
803-731-9600
803-731-9600
DelRicht Research - Thompson's Station
Smyrna, Tennessee 37167
Smyrna, Tennessee 37167
Contact:
629-895-1775
629-895-1775
Bellaire Dermatology Associates
Bellaire, Texas 77401
Bellaire, Texas 77401
Contact:
713-661-4383
713-661-4383
Modern Research Associates, PLLC
Dallas, Texas 75231
Dallas, Texas 75231
Contact:
214-361-2008
214-361-2008
Center for Clinical Studies
Houston, Texas 77004
Houston, Texas 77004
Contact:
713-528-8818
713-528-8818
Austin Institute for Clinical Research
Pflugerville, Texas 78660
Pflugerville, Texas 78660
Contact:
512-279-2545
512-279-2545
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
San Antonio, Texas 78218
Contact:
210-852-2779
210-852-2779
Center for Clinical Studies
Webster, Texas 77598
Webster, Texas 77598
Contact:
281-333-2288
281-333-2288
Tanner Clinic
Layton, Utah 84041
Layton, Utah 84041
Bellevue Dermatology Clinic
Bellevue, Washington 98104
Bellevue, Washington 98104
Contact:
425-455-2275
425-455-2275
Dermatology of Seattle
Burien, Washington 98168
Burien, Washington 98168
Contact:
206-248-5020
206-248-5020
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com