Crohn's DiseaseNCT06856135
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
A study testing Vedolizumab IV in people with Crohn's Disease and Ulcerative Colitis, run by Takeda at 3 sites in United States.
Trial summary
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Vedolizumab IV
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- The participant has UC or CD and is of age less than (<) 18 years at the time of final treatment completion of Vedolizumab-2005.
- The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.
- The participant, participant's legally authorized representative, or adult caregiver is informed of the nature of this expanded access program and has provided signed and dated written informed consent and/or pediatric assent.
- The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.
- The participant does not have a known hypersensitivity to vedolizumab or its components.
- According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.
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- Female participants of childbearing potential only:
- The participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after completion of the last dose of vedolizumab.
- The participant is not pregnant or breastfeeding.
- The participant will not donate ova during the course of the program and for 18 weeks after the last dose of vedolizumab.
- Male participants only:
- The participant has agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after the last dose of vedolizumab.
- The participant has agreed to not donate sperm during the course of the program and for 18 weeks after the last dose of vedolizumab.
Who cannot join
- -No specific exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
- Available
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342
Site Contact, 404-257-0799, bgold@gicareforkids.com
Benjamin Gold, Dr.
- Available
University of California San Francisco
San Francisco, California, 94158
Site Contact, 415-476-1000, mel.heyman@ucsf.edu
Melvin Heyman, Dr.
- Available
Seattle Children's Hospital
Seattle, Washington, 98105
Site Contact, 206-987-2000, ghassan.wahbeh@seattlechildrens.org
Ghassan Wahbeh, Dr.
About this study
Official title: Expanded Access Program for United States of America: Vedolizumab Intravenous for the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to Vedolizumab Intravenous (IV) which is given as infusion into a vein (intravenously IV) until it becomes commercially available in the US. To be able to participate in this EAP, children and teenagers must still benefit from the treatment with Vedolizumab IV. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Vedolizumab IV
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab IVDrug
Participants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks.
- Other Names:
- MLN0002
- ENTYVIO
- KYNTELES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856135
- Sponsor's protocol ID
- Vedolizumab 4072
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for United States of America: Vedolizumab Intravenous for the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease
- ClinicalTrials.gov ID
- NCT06856135
- Acronym / sponsor ID
- Vedolizumab 4072
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Drug Therapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to Vedolizumab Intravenous (IV) which is given as infusion into a vein (intravenously IV) until it becomes commercially available in the US. To be able to participate in this EAP, children and teenagers must still benefit from the treatment with Vedolizumab IV. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- The participant has UC or CD and is of age less than (<) 18 years at the time of final treatment completion of Vedolizumab-2005.
- The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.
- The participant, participant's legally authorized representative, or adult caregiver is informed of the nature of this expanded access program and has provided signed and dated written informed consent and/or pediatric assent.
- The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.
- The participant does not have a known hypersensitivity to vedolizumab or its components.
Key exclusion criteria (1 listed)
- -No specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab IVParticipants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks. • Other Names: * MLN0002 * ENTYVIO * KYNTELES | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vedolizumab IV in people with Crohn's Disease and Ulcerative Colitis, run by Takeda at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.