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
Royal Adelaide Hospital ( Site 4100)
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Vojenská Nemocnice Brno-Internal department ( Site 0701)
Brno, Brno-mesto 615 00
CzechiaActive - Recruiting
Hepato-Gastroenterologie HK ( Site 0700)
Hradec Kralove, 50012
CzechiaActive - Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)
Nice, Alpes-Maritimes 06202
FranceActive - Recruiting
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)
Neuilly Sur Seine, Hauts-de-Seine 92200
FranceActive - Recruiting
CHRU De Nancy - Hopital de Brabois ( Site 1001)
Vandoeuvre-les-Nancy, Meurthe-et-Moselle 54500
FranceActive - Recruiting
Hopital Claude Huriez CHRU LILLE ( Site 1004)
Lille, Nord 59037
FranceActive - Recruiting
ARENSIA Exploratory Medicine Georgia ( Site 1104)
Tbilisi, 0112
GeorgiaActive - Recruiting
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)
Bekescsaba, Bekes 5600
HungaryActive - Recruiting
Semmelweis Egyetem ( Site 1400)
Budapest, 1082
HungaryActive - Recruiting
Melita Medical ( Site 2204)
Wroclaw, Dolnoslaskie 53-611
PolandActive - Recruiting
Przychodnia Futuremeds Wroclaw ( Site 2211)
Wroclaw, Dolnoslaskie 53-673
PolandActive - Recruiting
Centrum Medyczne Oporow ( Site 2212)
Wrocław, Dolnoslaskie 52-416
PolandActive - Recruiting
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)
Wloclawek, Kujawsko-pomorskie 87-800
PolandActive - Recruiting
Bonifraterskie Centrum Medyczne ( Site 2207)
Lodz, Lodzkie 93-357
PolandActive - Recruiting
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)
Lublin, Lubelskie 20-059
PolandActive - Recruiting
Medrise Sp. z o.o. ( Site 2200)
Lublin, Lubelskie 20-582
PolandActive - Recruiting
Krakowskie Centrum Medyczne ( Site 2210)
Krakow, Malopolskie 31-501
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
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)
Warszawa, Mazowieckie 04-501
PolandActive - Recruiting
Vita Longa Sp. Zoo ( Site 2213)
Katowice, Slaskie 40-748
PolandActive - Recruiting
Rivermed Sp. z.o.o. ( Site 2206)
Poznan, Wielkopolskie 61-441
PolandActive - Recruiting
Sonomed Sp. z o. o. ( Site 2203)
Szczecin, Zachodniopomorskie 71-685
PolandActive - Recruiting
Whipps Cross University Hospital ( Site 3400)
London, England E11 1NR
United KingdomActive - Recruiting
MAC Research - Merseyside ( Site 3401)
Prescot, Knowsley L34 1BH
United KingdomActive - 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
New York Gastroenterology Associates ( Site 0253)
New York, New York 10075
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
University of Virginia Health System ( Site 0291)
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Washington Gastroenterology - Tacoma ( Site 0295)
Tacoma, Washington 98405
United StatesActive - Recruiting
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