Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

April 21, 2026 updated by: Takeda

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Study Overview

Status

Status

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

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.

Detailed Description

The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.

This study will look at the long-term safety profile in participants who take vedolizumab IV. Participants will continue receiving the same dose assigned from the parent study MLN0002-2003 [NCT03138655], which will remain blinded until week 40.

The dosing regimen selected for the long-term study is intended to maintain clinical response at the lowest possible exposure.

At the discretion of the investigator, participants receiving the low dose (150 or 100 milligram [mg]) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).

Participants who experience continued disease worsening during the study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.

Study duration will be until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug, the participant withdraws from the study, or the sponsor decides to close the study (up to approximately 8 years).

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 (Actual)

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.
59

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 2

Contacts and Locations

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

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Hôpital Necker-Enfants Malades
  • Hungary
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
        • BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Központ
  • Israel
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Petach Tiqwa, Israel, 4920235
        • Schneider Children's Medical Center of Israel
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52621
        • The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-663
        • Uniwersytecki Szpital Dzieciecy w Krakowie
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
        • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 91-738
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
  • Ukraine
      • Kharkiv, Ukraine, 61093
        • Kharkiv Regional Clinical Children's Hospital
  • United Kingdom
    • England
      • London, England, United Kingdom, E1 1BB
        • Barts and The London NHS Trust
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Francisco, California, United States, 94158
        • University of California San Francisco
    • Connecticut
      • Hartford, Connecticut, United States, 06106-3322
        • Connecticut Children's Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Childrens Specialty Care - Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Center for Digestive Healthcare
    • New York
      • New York, New York, United States, 10031
        • Columbia University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.

    (Note: A participant remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)

  2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.

  3. May be receiving a therapeutic dose of the following drugs:

    • Oral 5-aminosalicylic acid (5-ASA) compounds.
    • Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
    • Topical (rectal) treatment with 5-ASA or corticosteroids.
    • Probiotics (example, Saccharomyces boulardii).
    • Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
    • Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
    • Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
  4. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.

Exclusion Criteria:

  1. Is female and is lactating or pregnant.
  2. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
  3. Has withdrawn from Study MLN0002-2003.
  4. Has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
  6. Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
  7. Has other serious comorbidities that will limit his or her ability to complete the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Vedolizumab High Dose Group
Participants with UC or CD having baseline weight of greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
Experimental: Vedolizumab Low Dose Group
Participants with UC or CD having baseline weight of >= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of < 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).
Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES

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 With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug up to end of follow up (up to 6.8 years)
AE defined as any untoward medical occurrence in clinical investigation participants administered drug; it does not necessarily have to have causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it was considered related to the drug. TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug, or an already-present AE that worsened in intensity or frequency following the treatment start, occurring from the first dose of study drug to the day of last dose of study drug.
From first dose of study drug up to end of follow up (up to 6.8 years)

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
Percentage of Participants With UC Who Achieved and Maintained Clinical Response Based on Complete Mayo Score
Time Frame: At Week 32
Clinical response was defined as a continued reduction in complete Mayo score of >=3 points and >=30 percent (%) from baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of >=1 point from baseline, or absolute rectal bleeding subscore of less than or equal to (<=1) point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings on endoscopy and physician rating of disease activity, each graded from 0 to 3 where 0 indicated normal and 3 indicated more severe disease. These scores were summed to give a total score range of 0 to 12; where higher scores indicated more severe disease.
At Week 32
Percentage of Participants With CD Who Achieved and Maintained Clinical Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score and Crohn's Disease Activity Index (CDAI) at Week 32
Time Frame: At Week 32
Maintenance of clinical response based on SES-CD and CDAI was defined as a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy [at initiation of MLN0002-2003 (NCT03138655)]; and continued reduction in CDAI that is a >= 70 point decrease from the baseline CDAI score at the initiation of MLN0002-2003 (NCT03138655). CDAI was a research tool used to quantify the symptoms of participants with Crohn's disease. SES-CD consisted of 3 variables: ulcer size, ulcerated and affected surfaces and presence of narrowing each graded from 0 to 3 with score of 0 means no colonic lesions or mucosal healing, and SES-CD greater than (>) 1 indicated the presence of mucosal lesions.
At Week 32
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Time Frame: Up to 6.8 years
Time to major IBD-related events was defined as time from study treatment start to first major IBD-related hospitalization, surgery, or procedure due to UC and CD.
Up to 6.8 years
Change From Baseline in IMPACT-III - Total Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III used a 5-point Likert scale ranging from 1 to 5 for all answers. The total score was obtained by summing individual domain scores. The total score ranged from 35 to 175, with higher scores suggesting better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Bowel Symptoms Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The Bowel Symptoms domain consisted of 7 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The bowel symptoms domain score ranged from 7 to 35, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Systemic Symptoms Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The systemic symptoms domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The systemic symptoms domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Social Functioning Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The social functioning domain consisted of 12 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The social functioning domain score ranged from 12 to 60, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Body Image Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The body image domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The body image domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Treatment/Interventions Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The treatment/interventions domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The treatment/interventions domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Change From Baseline in IMPACT-III - Emotional Functioning Domain Score
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The emotional functioning domain consisted of 7 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The emotional functioning domain score ranged from 7 to 35, with higher scores suggesting a better quality of life.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312
Height Velocity at Week 48 and Every 48 Weeks
Time Frame: At Weeks 48, 96, 144, 192, 240, 288, and 336
Height velocity (centimeter per year [cm/year]) was calculated as the change in height divided by the duration [time between the two height measures].
At Weeks 48, 96, 144, 192, 240, 288, and 336
Change From Baseline in Height
Time Frame: Baseline, Weeks 48, 96, 144, 192, 240, 288, 336
Change from baseline in height was reported.
Baseline, Weeks 48, 96, 144, 192, 240, 288, 336
Change From Baseline in Weight
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, and 336
Change from baseline in weight was reported.
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, and 336
Change From Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, and 336
BMI was calculated as Weight (in kilograms)/height (in meters square).
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, and 336
Percentage of Participants Who Achieved Tanner Stage V at or Before Age 16 (in Females) or Age 17 (in Males)
Time Frame: Up to 6.8 years
Tanner Stage Evaluation was a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage was assessed at or before age 16 years for females or 17 years for males.
Up to 6.8 years

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.
Takeda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda Development Center Americas, Inc.

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: Study Director, Takeda

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.
July 30, 2018

Primary Completion (Actual)

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.
April 3, 2025

Study Completion (Actual)

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 17, 2025

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).
June 20, 2017

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.
June 20, 2017

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.
June 22, 2017

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.
May 13, 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.
April 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.
April 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.
  • Vedolizumab-2005
  • 2017-002182-21 (EudraCT Number)
  • U1111-1176-5741 (Other Identifier: WHO)
  • 17/NE/0258 (Registry Identifier: NRES)
  • MOH_2017-09-18_000649 (Other Identifier: CRS)
  • 2023-507766-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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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