A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-X)

August 21, 2026 updated by: Eli Lilly and Company

A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

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.
190

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 3

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

  • Argentina
      • Rosario, Argentina, S2000
        • Recruiting
        • Instituto CAICI SRL
        • Contact:
          • Phone Number: 543414248045
        • Principal Investigator:
          • Diego Viola
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Medicas Tucuman
        • Contact:
          • Phone Number: +54-381-4200180
        • Principal Investigator:
          • Alberto Spindler
  • Australia
      • Melbourne, Australia, 3052
        • Not yet recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Jonathan Akikusa
      • Perth, Australia, 6009
        • Not yet recruiting
        • Perth Children's Hospital
        • Contact:
          • Phone Number: 61264564348
        • Principal Investigator:
          • Kevin Murray
      • Westmead, Australia, 2145
        • Active, not recruiting
        • The Children's Hospital at Westmead
  • Austria
      • Bregenz, Austria, 6900
        • Completed
        • Landeskrankenhaus Bregenz
  • Belgium
      • Brussels, Belgium, 1200
        • Completed
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Joke Dehoorne
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: 3216343801
        • Principal Investigator:
          • Lien De Somer
  • Brazil
      • Botucatu, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP
        • Principal Investigator:
          • Claudia Magalhaes
      • São Paulo, Brazil, 04024-002
        • Recruiting
        • Universidade Federal de Sao Paulo
        • Principal Investigator:
          • Maria Teresa Terreri
        • Contact:
          • Phone Number: 5511 55792581
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
        • Principal Investigator:
          • Clovis Silva
        • Contact:
          • Phone Number: 551126618840
  • China
      • Beijing, China, 100045
        • Active, not recruiting
        • Beijing Children's Hospital, Capital Medical University
      • Chongqing, China, 400065
        • Active, not recruiting
        • The Children's Hospital of Chongqing Medical University
      • Nanjing, China, 210008
        • Not yet recruiting
        • Childrens Hospital of Nanjing Medical University
        • Principal Investigator:
          • Haiguo Yu
      • Suzhou, China, 215025
        • Recruiting
        • Children's Hospital of Soochow University
        • Principal Investigator:
          • Qihua Feng
  • Czechia
      • Brno, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno
        • Contact:
          • Phone Number: 420532234482
        • Principal Investigator:
          • Marcel Schuller
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice Motol
        • Principal Investigator:
          • Rudolf Horvath
        • Contact:
          • Phone Number: 420727812317
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna Fakultni Nemocnice V Praze
        • Principal Investigator:
          • Pavla Dolezalova
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Mia Glerup
        • Contact:
          • Phone Number: +45 61333138
  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hopital Femme Mere Enfant
        • Principal Investigator:
          • Alexandre BELOT
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • isabelle Kone-Paut
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
        • Principal Investigator:
          • Tu-Anh TRAN
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Principal Investigator:
          • Pierre Quartier Dit Maire
        • Contact:
          • Phone Number: +33144494828
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • Elisabeth Gervais
  • Germany
      • Berlin, Germany, 13125
        • Active, not recruiting
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 13353
        • Completed
        • Charité Campus Virchow-Klinikum
      • Hamburg, Germany, 22081
        • Active, not recruiting
        • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
      • Heidelberg, Germany, 69115
        • Completed
        • Universitätsklinikum Heidelberg
      • Sankt Augustin, Germany, 53757
        • Active, not recruiting
        • Asklepios Klinik Sankt Augustin
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Universitaetsklinikum Tuebingen
  • India
      • Chennai, India, 600116
        • Completed
        • Sri Ramachandra MedicaL College & Research Institute
      • New Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Sujata Sawhney
      • Vellore, India, 632004
        • Recruiting
        • Christian Medical College Vellore
        • Principal Investigator:
          • Sathish Kumar
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • Yonatan Butbul
        • Contact:
          • Phone Number: 9727774513
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Ruby Haviv
      • Petah Tikva, Israel, 49202
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Gil Amarilyo
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Irit Tirosh
  • Italy
      • Brescia, Italy, 25123
        • Active, not recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Chieti, Italy, 66100
        • Completed
        • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
      • Genova, Italy, 16147
        • Active, not recruiting
        • IRCCS Istituto Giannina Gaslini
      • Milan, Italy, 20122
        • Not yet recruiting
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
        • Principal Investigator:
          • Achille Marino
      • Milan, Italy, 20122
        • Completed
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Naples, Italy, 80131
        • Active, not recruiting
        • University of Naples Federico II
      • Palermo, Italy, 90127
        • Not yet recruiting
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
        • Principal Investigator:
          • Maria Cristina Maggio
        • Contact:
          • Phone Number: 39 091 0916666250
      • Trieste, Italy, 34137
        • Completed
        • Ospedale Infantile Burlo Garofolo
  • Japan
      • Bunkyō, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Shimizu
      • Chiba, Japan, 266-0007
        • Recruiting
        • Chiba Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Minako Tomiita
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuichi Yamasaki
      • Kanazawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tadafumi Yokoyama
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Utako Kaneko
      • Saitama-shi, Japan, 330 8777
        • Recruiting
        • Saitama Children's Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoshi Sato
      • Sendai, Japan, 989-3126
        • Recruiting
        • Miyagi Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Umebayashi
      • Shinjuku-ku, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takako Miyamae
      • Takatsuki, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuko Sugita
      • Yokohama, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichi Ito
      • Yokohama, Japan, 232-8555
        • Recruiting
        • Kanagawa Children's Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoyuki Imagawa
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua
        • Contact:
          • Phone Number: 526144373003
        • Principal Investigator:
          • Cesar Pacheco-Tena
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Clínicas para la Salud
        • Principal Investigator:
          • Edgar Hernandez
        • Contact:
          • Phone Number: +52 1 618 812 5351
      • Guadalajara, Mexico, 44600
        • Recruiting
        • Crea de Guadalajara
        • Principal Investigator:
          • Gabriel Vega Cornejo
      • Monterrey, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. José Eleuterio González"
        • Principal Investigator:
          • Nadina Rubio Perez
        • Contact:
          • Phone Number: 8183338623
      • México, Mexico, 6700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
          • Phone Number: 525552561496
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
  • Poland
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
        • Principal Investigator:
          • Zbigniew Zuber
        • Contact:
          • Phone Number: +48 126198630
      • Lodz, Poland, 91-738
        • Recruiting
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Elzbieta Smolewska
        • Contact:
          • Phone Number: +48426177700
      • Warsaw, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
        • Principal Investigator:
          • Piotr Gietka
  • Russia
      • Moscow, Russia, 115522
        • Completed
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Russia, 119991
        • Completed
        • Scientific Center of Children's Health
  • Spain
      • Esplugues de Llobregat, Spain, 8950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Principal Investigator:
          • Jordi Anton
        • Contact:
          • Phone Number: (34)936009733
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Alina Lucica Boteanu
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Rosa Alcobendas
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • Marisol Camacho Lovillo
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Phone Number: +34961244792
        • Principal Investigator:
          • LUCIA LACRUZ PEREZ
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
        • Principal Investigator:
          • Ozgur Kasapcopur
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Recruiting
        • Bristol Royal Hospital for Children
        • Principal Investigator:
          • Athimalaipet Ramanan
      • Liverpool, United Kingdom, L14 5AB
        • Recruiting
        • Alder Hey Children's Hospital
        • Principal Investigator:
          • Beverley Almeida
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
        • Principal Investigator:
          • Muthana Al Obaidi
      • Oxford, United Kingdom, OX3 7LD
        • Recruiting
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
        • Principal Investigator:
          • Inga Turtsevich
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Principal Investigator:
          • Daniel Hawley

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have completed a previous study of baricitinib for the treatment of JIA.

Exclusion Criteria:

  • Participants must not have had a permanent discontinuation of baricitinib in the prior study.
  • Participants must have not developed an allergy to baricitinib.

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: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

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
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Time Frame: Baseline through Week 264
Number of participants with one or more SAEs
Baseline through Week 264
Number of Participants with Permanent Investigational Product Discontinuations
Time Frame: Baseline through Week 264
Number of participants with permanent investigational product discontinuations
Baseline through Week 264

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
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Time Frame: Week 264
Proportion of participants achieving PedACR30
Week 264
Proportion of Participants who have Disease Flare
Time Frame: Baseline through Week 264
Proportion of participants who have disease flare
Baseline through Week 264
Proportion of Participants with Inactive Disease
Time Frame: Week 264
Proportion of participants with inactive disease
Week 264
Proportion of Participants with Minimal Disease Activity
Time Frame: Week 264
Proportion of participants with minimal disease activity
Week 264
Proportion of Participants in Remission
Time Frame: Week 264
Proportion of participants in remission
Week 264
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Time Frame: Baseline, Week 264
Change from baseline of originating study in JADAS27
Baseline, Week 264
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Time Frame: Baseline, Week 264
Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
Baseline, Week 264
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline, Week 264
Change from baseline in PASI
Baseline, Week 264
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Time Frame: Baseline, Week 264
Change from baseline in SPARCC enthesitis index
Baseline, Week 264
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Time Frame: Baseline, Week 264
Change from baseline in JSpADA
Baseline, Week 264
Change from Baseline in Immunoglobulin Levels
Time Frame: Baseline, Week 264
Change from baseline in immunoglobulin levels
Baseline, Week 264
Change from Baseline in Immunophenotyping (T Cells)
Time Frame: Baseline, Week 264
Change from baseline in immunophenotyping (T Cells)
Baseline, Week 264
Change of Immunoglobulin G (IgG) Titers
Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination
Change of IgG titers
Pre-Vaccination to 12 Weeks Post-Vaccination

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.
April 5, 2019

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.
July 1, 2031

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.
July 1, 2031

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).
December 11, 2018

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.
December 11, 2018

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.
December 12, 2018

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.
August 24, 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.
August 21, 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.
August 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 16278
  • 2017 (U.S. NIH Grant/Contract)
  • I4V-MC-JAHX (Other Identifier: Eli Lilly and Company)
  • 2017-004471-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

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

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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