Phase 2
Completed N=59
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Ulcerative Colitis · Crohn's Disease
Source: ClinicalTrials.gov NCT03196427 ↗
Enrolled (actual)
59
Serious AEs
34.5%
Results posted
Mar 2026
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 100; 83.3; 100; 100 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
100; 83.3; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With UC Who Achieved and Maintained Clinical Response Based on Complete Mayo Score |
50.0; 75.0; 100; 50 | — |
| SECONDARY Percentage of Participants With CD Who Achieved and Maintained Clinical Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score and Crohn's Disease Activity Index (CDAI) at Week 32 |
83.3; 28.6; 0; 50.0 | — |
| SECONDARY Time to Major Inflammatory Bowel Disease (IBD) - Related Events |
NA; NA; NA; NA; NA; 2058.00 | — |
| SECONDARY Change From Baseline in IMPACT-III - Total Score |
1.0; 13.0; 10.0; 9.0; -4.3; 8.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Bowel Symptoms Domain Score |
2.5; 3.0; 6.0; 1.0; 0.7; 2.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Systemic Symptoms Domain Score |
2.0; 3.0; 3.0; 0.0; -1.1; 0.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Social Functioning Domain Score |
0.0; 3.0; 0.0; 3.5; -1.7; 1.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Body Image Domain Score |
-2.5; 0.5; -2.0; 1.5; -0.3; -1.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Treatment/Interventions Domain Score |
-1.0; 2.0; 0.0; 1.0; 0.1; 1.0 | — |
| SECONDARY Change From Baseline in IMPACT-III - Emotional Functioning Domain Score |
0.0; 1.5; 3.0; 2.0; -2.0; 5.0 | — |
| SECONDARY Height Velocity at Week 48 and Every 48 Weeks |
0.02; 0.02; 0.02; 0.01; 0.01; 0.01 | — |
| SECONDARY Change From Baseline in Height |
5.80; 6.44; 8.30; 5.08; 4.64; 3.22 | — |
| SECONDARY Change From Baseline in Weight |
1.40; 2.44; 2.31; 0.88; 2.04; -1.10 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
0.22; 0.31; 0.26; -0.10; 0.31; -0.60 | — |
| SECONDARY Percentage of Participants Who Achieved Tanner Stage V at or Before Age 16 (in Females) or Age 17 (in Males) |
100; 100; 100; 100; 100; 50 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
(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.)
- 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:
- Oral 5-aminosalicylic acid (5-ASA) compounds.
- Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
- Topical (rectal) treatment with 5-ASA or corticosteroids.
- Probiotics (example, Saccharomyces boulardii).
- Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
- Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
- Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
- The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
Exclusion Criteria
- 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.
- Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- Has other serious comorbidities that will limit his or her ability to complete the study.
Data sourced from ClinicalTrials.gov (NCT03196427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.