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Monoclonal Antibodies

Vedolizumab for Inflammatory Bowel Disease

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study medication through 18 weeks after the last dose
Awards & highlights

Study Summary

This trial is testing the long-term effects of Vedolizumab Subcutaneous on patients with Ulcerative Colitis and Crohn's Disease.

Who is the study for?
This trial is for adults with Ulcerative Colitis or Crohn's Disease who were in previous studies MLN0002SC-3027 or MLN0002SC-3031 and tolerated Vedolizumab well. It's not for those who had surgery for IBD, severe infections, unstable health conditions, or withdrew from the earlier studies due to adverse effects of the drug.Check my eligibility
What is being tested?
The study tests long-term side effects and effectiveness of Vedolizumab SC injections in managing Ulcerative Colitis and Crohn's Disease. Participants will receive injections weekly or biweekly based on their past response and disease activity, with possible dose adjustments if their condition worsens.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, risk of infection, headache, nausea, fever, fatigue, joint pain. Long-term risks are being studied but may involve immune system changes since Vedolizumab affects how it works.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study medication through 18 weeks after the last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study medication through 18 weeks after the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Secondary outcome measures
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission
Percentage of Participants with Crohn's Disease Achieving Clinical Response
+2 more

Side effects data

From 2015 Phase 1 trial • 48 Patients • NCT02163421
25%
Headache
17%
Nasopharyngitis
8%
Seasonal allergy
8%
Oropharyngeal pain
8%
Dizziness
8%
Rhinitis
8%
Cough
8%
Hordeolum
8%
Decreased appetite
8%
Somnolence
8%
Rhinorrhoea
8%
Pyrexia
8%
Toothache
8%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab Intravenous 300 mg
Vedolizumab Subcutaneous 54 mg
Vedolizumab Subcutaneous 160 mg
Vedolizumab Subcutaneous 108 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Vedolizumab SC 108 mg QWExperimental Treatment1 Intervention
Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure. •Participants from current study who experience treatment failure while on study.
Group II: Group A: Vedolizumab SC 108 mg Q2WExperimental Treatment1 Intervention
Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who: Completed the Maintenance Period (Week 52), or Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab SC
2018
Completed Phase 1
~410

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,516 Total Patients Enrolled
24 Trials studying Ulcerative Colitis
9,254 Patients Enrolled for Ulcerative Colitis
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
62,501 Total Patients Enrolled
1 Trials studying Ulcerative Colitis

Media Library

Vedolizumab SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02620046 — Phase 3
Ulcerative Colitis Research Study Groups: Group A: Vedolizumab SC 108 mg Q2W, Group B: Vedolizumab SC 108 mg QW
Ulcerative Colitis Clinical Trial 2023: Vedolizumab SC Highlights & Side Effects. Trial Name: NCT02620046 — Phase 3
Vedolizumab SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02620046 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many risks associated with Vedolizumab SC?

"Vedolizumab SC is a Phase 3 trial drug, meaning that while there are some efficacy data, multiple rounds of safety trials have been conducted. Consequently, our team rates it as a 3 on the Power scale."

Answered by AI

Is this research study the first of its kind?

"Vedolizumab SC has been under clinical observation since 2015. In that year, Takeda conducted the first trial which then led to Phase 4 drug approval in 260 cases. As of now, there are 23 active studies involving Vedolizumab SC being carried out in 312 cities and 42 nations worldwide."

Answered by AI

Are there comparable investigations to the Vedolizumab SC study?

"Vedolizumab SC was first trialed in 2015 at AZ Delta Roeselare, with 38 completed studies as of now. 23 more trials are ongoing, mostly based out of Tulsa, Oklahoma."

Answered by AI

Does this research project allow adults aged 55 and up to participate?

"According to the study's rules, the minimum age for participation is 18 and the maximum age is 80."

Answered by AI

Who is qualified to participate in this research?

"This study is looking for 746 ulcerative colitis patients aged 18-80. Additionally, these potential participants must have already taken part in Study MLN0002SC-3027 or MLN0002SC-3031 and, according to the investigator's judgement, tolerated the medication well. Those who withdrew early from either of those studies due to treatment failure during the Maintenance Period are also eligible."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Georgia
What portion of applicants met pre-screening criteria?
Met criteria
How old are they?
18 - 65
What site did they apply to?
Atlanta Gastroenterology Associates
Recent research and studies
clinicaltrials.govStudy
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
2016. "A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02620046.
All > Inflammatory Bowel Disease > Colitis
~83 spots leftby Apr 2025
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