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Trial record 6 of 64 for:    vedolizumab

Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT03196427
First received: June 20, 2017
Last updated: June 22, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to determine vedolizumab IV safety profile, the effect of long-term treatment on time to major inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and procedures), to examine the effect on health-related quality-of- life measurements and to determine the effect on patterns of growth and development in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD).

Condition Intervention Phase
Ulcerative Colitis Crohn's Disease Drug: Vedolizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 5 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.


Secondary Outcome Measures:
  • Time to Major Inflammatory Bowel Disease (IBD) - Related Events [ Time Frame: Baseline up to 5 years ]
    Major IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis (UC) and Crohn's disease (CD).

  • Changes from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
    The IMPACT-III questionnaire is 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 uses a 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.

  • Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
    Height velocity (cm/year) is the change in height per year.

  • Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
  • Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
  • Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
    BMI = Weight (in kilograms)/height^2 (in meters).

  • Percentage of Participants Achieving Tanner Stage V Scale [ Time Frame: Baseline up to 5 years ]
    Tanner Stage Evaluation is 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 is assessed at or before age 16 years for females or 17 years for males.


Estimated Enrollment: 80
Anticipated Study Start Date: November 10, 2017
Estimated Study Completion Date: June 14, 2025
Estimated Primary Completion Date: February 8, 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab High Dose Group
Participants with UC or CD having baseline weight of ≥30 kg will receive Vedolizumab 300 mg and participants with UC or CD having baseline weight of <30 kg will receive Vedolizumab 200 mg, intravenous (IV) infusion every 8 weeks for up to 5 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 for up to 5 years.
Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES

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. Participants will roll over from the randomized double blind study (MLN0002-2003) to the Vedolizumab-2005 Open Label Extension (OLE) study maintaining the dose at study entry and escalating the dose at disease worsening.

The dosing regimen selected for the long-term OLE 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 OLE 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).

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is male or female with Ulcerative Colitis or Crohn's Disease and was between 2 to 17 years, inclusive, at the time of their first dose of study drug in 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 in the opinion of the investigator is expected to benefit from continued vedolizumab treatment.
  3. Have a family history of colorectal cancer (i.e., first-degree relative), personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
  4. May be receiving a therapeutic dose of the following drugs:

    1. Oral 5-aminosalicylic acid (5-ASA) compounds.
    2. Oral corticosteroid therapy (prednisone or equivalent steroid at a dose ≤50 mg/day, budesonide at a dose ≤9 mg/day).
    3. Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories.
    4. Probiotics (e.g., Saccharomyces boulardii).
    5. Antidiarrheals (e.g., loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
    6. Antibiotics used for the treatment of Crohn's disease (CD) (i.e., ciprofloxacin, metronidazole).
    7. Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
  5. The participant's vaccinations are up to date (MLN0002-2003 10# inclusion criteria).

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 (e.g., 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03196427

Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Monitor Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03196427     History of Changes
Other Study ID Numbers: Vedolizumab-2005
2017-002182-21 ( EudraCT Number )
U1111-1176-5741 ( Other Identifier: WHO )
Study First Received: June 20, 2017
Last Updated: June 22, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 21, 2017