Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tralokinumab; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • Leo Pharma Investigationel Site
  • Kogarah, Australia, 2217
    • Leo Pharma Investigationel Site
  • Melbourne, Australia, 3002
    • Leo Pharma Investigationel Site
  • Woolloongabba, Australia, 4102
    • Leo Pharma Investigationel Site
• Belgium
  • Brussels, Belgium, 1200
    • Leo Pharma Investigationel Site
  • Gent, Belgium, B-9000
    • Leo Pharma Investigationel Site
  • Liège, Belgium, 4000
    • Leo Pharma Investigationel Site
  • Maldegem, Belgium, 9990
    • LEO Pharma Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • LEO Pharma Investigational Site
    • Edmonton, Alberta, Canada, T6G 1C9
      • LEO Pharma Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • LEO Pharma Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • LEO Pharma Investigational Site
    • Winnipeg, Manitoba, Canada, R3C 1T6
      • LEO Pharma Investigational Site
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • LEO Pharma Investigational Site
    • Oakville, Ontario, Canada, L6J 7W5
      • LEO Pharma Investigational Site
    • Toronto, Ontario, Canada, M5A 3R6
      • LEO Pharma Investigational Site
    • Windsor, Ontario, Canada, N8X 2G1
      • LEO Pharma Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • LEO Pharma Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • LEO Pharma Investigational Site
• France
  • Marseille, France, 13285
    • Leo Pharma Investigationel Site
  • Nice, France, 06200
    • Leo Pharma Investigationel Site
  • Paris, France, 75015
    • Leo Pharma Investigationel Site
  • Paris, France, 75020
    • Leo Pharma Investigationel Site
  • Valence, France, 26000
    • Leo Pharma Investigationel Site
• Germany
  • Berlin, Germany, 10115
    • Leo Pharma Investigationel Site
  • Dresden, Germany, 01307
    • Leo Pharma Investigationel Site
  • Jena, Germany, 49074
    • Leo Pharma Investigationel Site
  • Osnabrück, Germany, 49074
    • Leo Pharma Investigationel Site
• Japan
  • Fukuoka, Japan, 814-0180
    • Leo Pharma Investigationel Site
  • Kagoshima city, Japan, 890-8520
    • Leo Pharma Investigationel Site
  • Kyoto, Japan, 602-8566
    • Leo Pharma Investigationel Site
  • Nagoya-shi, Japan, 457-8510
    • Leo Pharma Investigationel Site
  • Obihiro, Japan, 080-0013
    • Leo Pharma Investigationel Site
  • Osaka, Japan, 593-8324
    • Leo Pharma Investigationel Site
  • Osaka-fu, Japan, 560-0085
    • Leo Pharma Investigationel Site
  • Shimotsuke, Japan, 329-0498
    • Leo Pharma Investigationel Site
  • Tokyo, Japan, 136-0074
    • Leo Pharma Investigationel Site
  • Tokyo, Japan, 141-8625
    • Leo Pharma Investigationel Site
  • Tokyo, Japan, 169-0075
    • Leo Pharma Investigationel Site
  • Tokyo, Japan, 171-0022
    • Leo Pharma Investigationel Site
  • Tsu, Japan, 514-8507
    • Leo Pharma Investigationel Site
  • Yamanashi, Japan, 400-8506
    • Leo Pharma Investigationel Site
• Netherlands
  • Bergen Op Zoom, Netherlands, 4708
    • Leo Pharma Investigationel Site
  • Breda, Netherlands, 4818
    • Leo Pharma Investigationel Site
  • Groningen, Netherlands, 9713
    • Leo Pharma Investigationel Site
  • Rotterdam, Netherlands, 3015
    • Leo Pharma Investigationel Site
• Poland
  • Kraków, Poland, 30-033
    • Leo Pharma Investigationel Site
  • Kraków, Poland, 30-149
    • Leo Pharma Investigationel Site
  • Kraków, Poland, 31-011
    • Leo Pharma Investigationel Site
  • Rzeszów, Poland, 35-055
    • Leo Pharma Investigationel Site
  • Swidnik, Poland, 21-040
    • Leo Pharma Investigationel Site
  • Wrocław, Poland, 50-001
    • Leo Pharma Investigationel Site
  • Wrocław, Poland, 51-318
    • Leo Pharma Investigationel Site
  • Wrocław, Poland, 52-416
    • Leo Pharma Investigationel Site
  • Łódź, Poland, 90-265
    • Leo Pharma Investigationel Site
  • Łódź, Poland, 90-436
    • Leo Pharma Investigationel Site
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Leo Pharma Investigationel Site
  • London, United Kingdom, E11 1NR
    • Leo Pharma Investigationel Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • LEO Pharma Investigational Site
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • LEO Pharma Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • LEO Pharma Investigational Site
    • Los Angeles, California, United States, 90045
      • LEO Pharma Investigational Site
    • San Francisco, California, United States, 94132
      • LEO Pharma Investigational Site
    • Stanford, California, United States, 94304
      • LEO Pharma Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8059
      • LEO Pharma Investigational Site
  • Florida
    • Miami, Florida, United States, 33137
      • LEO Pharma Investigational Site
  • Georgia
    • Albany, Georgia, United States, 31707
      • LEO Pharma Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • LEO Pharma Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • LEO Pharma Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • LEO Pharma Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • LEO Pharma Investigational Site
    • Ypsilanti, Michigan, United States, 48197
      • LEO Pharma Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • LEO Pharma Investigational Site
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • LEO Pharma Investigational Site
  • New York
    • Corning, New York, United States, 14830
      • LEO Pharma Investigational Site
    • New York, New York, United States, 10075
      • LEO Pharma Investigational Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • LEO Pharma Investigational Site
  • Ohio
    • Bexley, Ohio, United States, 43209
      • LEO Pharma Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • LEO Pharma Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97223
      • LEO Pharma Investigational Site
    • Portland, Oregon, United States, 97239
      • LEO Pharma Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • LEO Pharma Investigational Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • LEO Pharma Investigational Site
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • LEO Pharma Investigational Site
  • Texas
    • Austin, Texas, United States, 78746
      • LEO Pharma Investigational Site
    • Houston, Texas, United States, 77030
      • LEO Pharma Investigational Site
    • San Antonio, Texas, United States, 78218
      • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 12 to 17.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• History of AD for ≥1 year.
• History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
• AD involvement of ≥10% body surface area at screening and baseline.
• Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Exclusion Criteria:

• Active dermatologic conditions that may confound the diagnosis of AD.
• Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
• Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
• Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents.
• Active skin infection within 1 week prior to randomisation.
• Clinically significant infection within 4 weeks prior to randomisation.
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
• Tuberculosis requiring treatment within the 12 months prior to screening.
• Known primary immunodeficiency disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA; Week 0 to 16 (initial period): Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 1) maintenance SC injection regimen A.	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB; Week 0 to 16 (initial period): Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 1) maintenance SC injection regimen B.	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA; Week 0 to 16 (initial period): Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 2) maintenance SC injection regimen A.	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB; Week 0 to 16 (initial period): Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 2) maintenance SC injection regimen B.	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Placebo initial-> Placebo maintenance; Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 52 (maintenance period): Placebo continuation SC injection regimen A.	Drug: Placebos; Placebo contains the same excipients in the same concentration only lacking tralokinumab.; Other Names: Placebo
Experimental: Tralokinumab (Dose1) initial-> Open-label tralokinumab; Week 0 to 16 (initial period): Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A. Week 16 to 52: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Tralokinumab (Dose2) initial-> Open-label tralokinumab; Week 0 to 16 (initial period): Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A. Week 16 to 52: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Experimental: Placebo initial-> Open-label tralokinumab; Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 52: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids	Drug: Tralokinumab; Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.; Drug: Placebos; Placebo contains the same excipients in the same concentration only lacking tralokinumab.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	At Week 16
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16	The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.	At Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16	The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.	From Week 0 to Week 16
Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16	The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.	From Week 0 to Week 16
Number of Adverse Events	Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.	From Week 0 to Week 16
Presence of Anti-drug Antibodies	Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.	From Week 0 to Week 16
Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 16
Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 16
Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	From Week 0 to Week 16
Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.	At Week 16
Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.	At Week 16
Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16	The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.	From Week 0 to Week 16
Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16	The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.	At Week 16
Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16	The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.	From Week 0 to Week 16
Tralokinumab Serum Trough Concentration at Week 16	Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.	At Week 16
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16	The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	At Week 52
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 52
Tralokinumab Serum Trough Concentration at Week 66	Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.	At Week 66

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Publications and helpful links

General Publications

• Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.
• Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, Hong HC, Imafuku S, Schuttelaar MLA, Simpson EL, Soong W, Arlert P, Lophaven KW, Kurbasic A, Soldbro L, Vest NS, Wollenberg A. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627. Erratum In: JAMA Dermatol. 2023 Jun 1;159(6):673. doi: 10.1001/jamadermatol.2023.1908.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: LP0162-1334; 2017-005143-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No