CompletedPhase 2

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

United States59 participantsStarted 2018-07-30

Plain-language summary

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

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.
✕. May be receiving a therapeutic dose of the following drugs:
✕. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
✕. Is female and is lactating or pregnant.
✕. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
✕. Has withdrawn from Study MLN0002-2003.
✕. 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.
✕. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug up to end of follow up (up to 6.8 years)

NCT IDNCT03196427

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-03

Results submitted2026-01-14

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.
✕. May be receiving a therapeutic dose of the following drugs:
✕. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
✕. Is female and is lactating or pregnant.
✕. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
✕. Has withdrawn from Study MLN0002-2003.
✕. 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.
✕. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.