Vedolizumab Subcutaneous Long-Term Open-Label Extension Study



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:12/26/2018
Start Date:April 15, 2016
End Date:February 10, 2022
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-877-825-3327

Use our guide to learn which trials are right for you!

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease

The purpose of this study is to obtain long term safety and tolerability data of vedolizumab
subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's
disease (CD).

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC).
Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating
participants with UC or CD. This study will look at the long-term side effects and
response/remission of UC and CD in participants who received vedolizumab SC in a prior
vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have
previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who
completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a
clinical response at Week 6 but who did achieve a clinical response at Week 14 after having
received a third vedolizumab IV infusion at Week 6 in their previous study, will receive
open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early
from the Maintenance Period of their previous study due to disease worsening or need for
rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW).
Participants who experience treatment failure (disease worsening or need for rescue
medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC
study will continue until vedolizumab SC becomes commercially available, the participant
withdraws from the study, or the sponsor decides to close the study. Participants will make
multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for
a follow-up assessment. Participants will also participate in a long-term safety follow-up,
by phone, at 6 months after the last dose of study drug.

Inclusion Criteria:

1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of
the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027
or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria:

1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or
MLN0002SC-3031, or at any time during this study.

2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular,
pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological,
coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other
medical disorder developed during or after participation in a prior vedolizumab study
that, in the opinion of the investigator, would confound the study results or
compromise participant safety.

3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related
adverse event (AE).
We found this trial at
48
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
701 West Morse Boulevard
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Belton, Missouri 64012
?
mi
from
Belton, MO
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
4190 Juan D. Peron
Ciudad Autonoma Buenos Aires, Buenos Aires C1181
?
mi
from
Ciudad Autonoma Buenos Aires,
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
Dayton, Ohio 45415
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
Germantown, Tennessee 37138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Idaho Falls, Idaho
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Inverness, Florida 34452
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Lafayette, Louisiana 70503
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
?
mi
from
Largo, FL
Click here to add this to my saved trials
2793 Shawnee Road
Lima, Ohio 45806
?
mi
from
Lima, OH
Click here to add this to my saved trials
Little Rock, Arkansas 72204
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
410 Saybrook Road
Middletown, Connecticut 06457
?
mi
from
Middletown, CT
Click here to add this to my saved trials
2645 North Mayfair Road
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Ocean Springs, Mississippi 39564
?
mi
from
Ocean Springs, MS
Click here to add this to my saved trials
1200 Breckenridge Street
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
12151 Taft Street
Pembroke Pines, Florida 33026
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Perkasie, Pennsylvania 18944
?
mi
from
Perkasie, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
520 East Euclid Avenue
San Antonio, Texas 78212
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
?
mi
from
Wyoming, MI
Click here to add this to my saved trials
Ypsilanti, Michigan 48197
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials
Zephyrhills, Florida 33542
?
mi
from
Zephyrhills, FL
Click here to add this to my saved trials