Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA

Takeda

Status

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Vedolizumab IV

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06856135

Vedolizumab 4072

Details and patient eligibility

About

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.

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The participant has UC or CD and is of age less than (<) 18 years at the time of final treatment completion of Vedolizumab-2005.

2. The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.

3. 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.

4. The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.

5. The participant does not have a known hypersensitivity to vedolizumab or its components.

6. 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.

7. 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.

8. 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.

Exclusion criteria

-No specific exclusion criteria.