Summary

for people ages 2-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Melvin Heyman

Description

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.

Official Title

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

Details

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 be randomly assigned (by chance, like flipping a coin) which will remain undisclosed to the participant and investigator during this double blind study (up to Week 40) maintaining the dose at study entry and escalating the dose at disease worsening.

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 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 is expected to be up to 5 years, depending on the enrollment rate in the previous randomized double blind study (MLN0002-2003).

Keywords

Ulcerative Colitis Crohn's Disease Drug Therapy Crohn Disease Colitis Ulcer Colitis, Ulcerative Vedolizumab

Eligibility

You can join if…

Open to people ages 2-17

  1. Is male or female with Ulcerative Colitis or Crohn's Disease 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

You CAN'T join if...

.)

  1. 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.
  2. May be receiving a therapeutic dose of the following drugs:
  3. Oral 5-aminosalicylic acid (5-ASA) compounds.
  4. Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day], budesonide at a dose <= 9 mg/day).
  5. Topical (rectal) treatment with 5-ASAs or corticosteroids.
  6. Probiotics (example, Saccharomyces boulardii).
  7. Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
  8. Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
  9. Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
  10. 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 ulcerative colitis (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.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143-0135 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT03196427
Phase
Phase 2
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated