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)

September 3, 2026 updated by: Eli Lilly and Company

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.

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

The study will last up to 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Completed
        • Reuviva Research Center
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • CMRC Headlands, LLC
        • Principal Investigator:
          • Maria Chirino
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
        • Principal Investigator:
          • Andrew Sharobeem
        • Contact:
          • Phone Number: 602-386-4971
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
        • Contact:
          • Phone Number: 480-443-8400
        • Principal Investigator:
          • Amer Al-Khoudari
      • Flagstaff, Arizona, United States, 86001
        • Active, not recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
      • Gilbert, Arizona, United States, 85297
        • Completed
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
      • Glendale, Arizona, United States, 85306
        • Active, not recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
      • Mesa, Arizona, United States, 85210
        • Active, not recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
        • Principal Investigator:
          • Areena Swarup
        • Contact:
          • Phone Number: 480-626-6637
      • Sun City, Arizona, United States, 85351
        • Active, not recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
      • Tucson, Arizona, United States, 85748
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
        • Principal Investigator:
          • Jawad Bilal
        • Contact:
          • Phone Number: 520-849-8753
      • Tucson, Arizona, United States, 85704
        • Active, not recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
    • California
      • Apple Valley, California, United States, 92307
        • Active, not recruiting
        • Medvin Clinical Research - Apple Valley
      • Covina, California, United States, 91722
        • Completed
        • Medvin Clinical Research - Covina
      • Huntington Beach, California, United States, 92648
        • Active, not recruiting
        • Newport Huntington Medical Group
      • La Mesa, California, United States, 91942
        • Active, not recruiting
        • Purushotham & Akther Kotha MD, Inc
      • Riverside, California, United States, 92508
        • Active, not recruiting
        • Medvin Clinical Research - Riverside
      • San Diego, California, United States, 92128
        • Active, not recruiting
        • Rheumatology Center of San Diego
      • Santa Monica, California, United States, 90404
        • Active, not recruiting
        • Providence Saint John's Medical Foundation
      • Temecula, California, United States, 92592
        • Active, not recruiting
        • Medvin Clinical Research - Temecula
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research - Tujunga
        • Contact:
          • Phone Number: 818-265-2250
        • Principal Investigator:
          • DAN LA
      • Whittier, California, United States, 90602
        • Active, not recruiting
        • Medvin Clinical Research - Whittier
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Active, not recruiting
        • Vida Clinical Research
      • Margate, Florida, United States, 33063
        • Active, not recruiting
        • Life Clinical Trials
      • Miami Beach, Florida, United States, 33140
        • Active, not recruiting
        • CZ Rheumatology
      • Palm Beach Gardens, Florida, United States, 33410
        • Active, not recruiting
        • Vitalia Medical Research
      • Tampa, Florida, United States, 33614
        • Completed
        • International Center for Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Active, not recruiting
        • Atlanta Research Center for Rheumatology
      • Waycross, Georgia, United States, 31501
        • Active, not recruiting
        • Satilla Rheumatology & Internal Medicine
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Active, not recruiting
        • Great Lakes Clinical Trials - Ravenswood
      • Schaumburg, Illinois, United States, 60195
        • Active, not recruiting
        • Greater Chicago Specialty Physicians
      • Skokie, Illinois, United States, 60076
        • Active, not recruiting
        • Arnold Arthritis & Rheumatology
      • Willowbrook, Illinois, United States, 60527
        • Active, not recruiting
        • Willow Rheumatology and Wellness PLLC
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Active, not recruiting
        • Lake Cumberland Rheumatology
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Completed
        • Accurate Clinical Research, Inc
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Active, not recruiting
        • Klein & Associates, M.D., P.A.
      • Hagerstown, Maryland, United States, 21740
        • Active, not recruiting
        • Klein & Associates, M.D., P.A.
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Active, not recruiting
        • Clinical Research Institute of Michigan, LLC
    • Montana
      • Kalispell, Montana, United States, 59901
        • Active, not recruiting
        • Logan Health Rheumatology
    • New York
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester Medical Center
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Active, not recruiting
        • Onsite Clinical Solutions, LLC - Brenner Ave
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Active, not recruiting
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Active, not recruiting
        • Essential Medical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Active, not recruiting
        • West Tennessee Research Institute
      • Murfreesboro, Tennessee, United States, 37128
        • Active, not recruiting
        • AARA Clinical Research - Murfreesboro Medical Clinic
    • Texas
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions - Colleyville
        • Principal Investigator:
          • Dhiman Basu
        • Contact:
          • Phone Number: 972-299-8399
      • Fort Worth, Texas, United States, 76109
        • Active, not recruiting
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
      • Houston, Texas, United States, 77089
        • Recruiting
        • Accurate Clinical Research, Inc
        • Principal Investigator:
          • Philip Waller
        • Contact:
          • Phone Number: 281-481-8557
      • Houston, Texas, United States, 77089
        • Active, not recruiting
        • Research Physicians Network, LLC
      • Irving, Texas, United States, 75039
        • Active, not recruiting
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
      • Katy, Texas, United States, 77494
        • Active, not recruiting
        • Biopharma Informatic, LLC
      • The Woodlands, Texas, United States, 77382
        • Active, not recruiting
        • Advanced Rheumatology of Houston - Woodlands
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research - TRA
        • Contact:
          • Phone Number: 281-517-0550
        • Principal Investigator:
          • Shaikh Ali
    • Washington
      • Seattle, Washington, United States, 98104
        • Active, not recruiting
        • Seattle Rheumatology Associates PLLC
      • Spokane Valley, Washington, United States, 99216
        • Active, not recruiting
        • Arthritis Northwest, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Time Frame: 12 Months
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
12 Months
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Time Frame: 12 Months
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change of Weight from Baseline
Time Frame: Baseline, Month 6 and Baseline, Month 12
Mean percent change of weight from baseline.
Baseline, Month 6 and Baseline, Month 12
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Time Frame: Month 6 and Month 12
Percentage of participants achieving TJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Time Frame: Month 6 and Month 12
Percentage of participants achieving SJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Time Frame: Month 6 and Month 12
Percentage of participants achieving BSA ≤3%.
Month 6 and Month 12
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
Time Frame: Month 6 and Month 12
The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Month 6 and Month 12
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Time Frame: Month 6 and Month 12
The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."
Month 6 and Month 12
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Time Frame: Month 6 and Month 12
The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Month 6 and Month 12
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
Time Frame: Month 6 and Month 12
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6 and Month 12
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Time Frame: Month 6 and Month 12
FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Time Frame: Month 6 and Month 12
The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Time Frame: Month 6 and Month 12
The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants Achieving a HAQ-DI score ≤0.5
Time Frame: Month 6
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6
Percentage of Participants with ≥10% Weight Loss at Month 6
Time Frame: Month 6
Percentage of participants with ≥10% weight loss at month 6.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27350
  • I1F-MC-RHDE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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