Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Placebo to tulisokibart
Tulisokibart
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CDor UC
The investigator determines that the participant derives clinical benefit fromcontinued study intervention based upon clinical evaluations performed during theirparent study
A participant assigned female sex at birth is not breastfeeding during the studyintervention period and for at least 14 weeks after the last dose of studyintervention
A participant of childbearing potential (POCBP) is not pregnant and has a negativehighly sensitive pregnancy test (urine or serum) as required by local regulationswithin 24 hours (for a urine test) or 72 hours (for a serum test) before the firstdose of study intervention
A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginalintercourse abstinence as their preferred and usual lifestyle (abstinent on along-term and persistent basis)
Exclusion
Exclusion Criteria:
Has prematurely discontinued study intervention in their parent study
Has received any protocol-specified prohibited medications during their parent study
Has known allergies, hypersensitivity, or intolerance to tulisokibart or itsexcipients
Study Design
Connect with a study center
Medrise Sp. z o.o. ( Site 2200)
Lublin, Lubelskie 20-582
PolandActive - Recruiting
Vivamed Sp. z o.o. ( Site 2201)
Warsawa, Mazowieckie 03-580
PolandActive - Recruiting
Centrum Zdrowia MDM ( Site 2202)
Warszawa, Mazowieckie 00-189
PolandActive - Recruiting
Vita Longa Sp. Zoo ( Site 2213)
Katowice, Slaskie 40-748
PolandActive - Recruiting
Sonomed Sp. z o. o. ( Site 2203)
Szczecin, Zachodniopomorskie 71-685
PolandActive - Recruiting
Connecticut Clinical Research Institute ( Site 0297)
Bristol, Connecticut 06010
United StatesActive - Recruiting
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
BVL Research - Kansas ( Site 0292)
Liberty, Missouri 64068
United StatesActive - Recruiting
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
Garland, Texas 75044
United StatesActive - Recruiting
Caprock Gastro Research ( Site 0293)
Lubbock, Texas 79424
United StatesActive - Recruiting
GI Alliance - Lubbock ( Site 0288)
Lubbock, Texas 79410
United StatesActive - Recruiting
Southern Star Research Institute ( Site 0299)
San Antonio, Texas 78229
United StatesActive - Recruiting
GI Alliance - Southlake ( Site 0298)
Southlake, Texas 76092-9167
United StatesActive - Recruiting
Tyler Research Institute ( Site 0294)
Tyler, Texas 75701
United StatesActive - Recruiting
Washington Gastroenterology - Tacoma ( Site 0295)
Tacoma, Washington 98405
United StatesActive - Recruiting
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