Phase
Condition
Ulcerative Colitis
Inflammatory Bowel Disease
Bowel Dysfunction
Treatment
Brazikumab Induction Dose
Brazikumab Maintenance Dose
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female participants with successful completion or early termination due tolack of efficacy from Study D5271C00001 (Legacy #3150-301-008). Meets 1 of the following criteria for successful completion or early termination dueto lack of efficacy from Study D5271C00001 (Legacy #3150-301-008):
- A participant is considered to have completed the D5271C00001 (Legacy
#3150-301-008) study if they have received scheduled study interventions,completed scheduled visits, and completed Week 52 assessments. 2. A participant in Study D5271C00001 (Legacy #3150-301-008) who discontinued fromthe study due to lack of efficacy after a minimum of 12 weeks of double-blindtreatment and met criteria for the use of rescue treatment in the lead-inprotocol. 2. Criterion deleted as part of Amendment. 3. Each participant must have had the ileocolonoscopic procedure at the final visit (Week 52, Week 12, or early termination after Week 12 of Study D5271C00001 (Legacy # 3150-301-008). 4. Female participants of childbearing potential must have a negative urine pregnancytest prior to administration of study intervention and must agree to use a highlyeffective method of birth control (confirmed by the investigator) from signing the ICFthroughout the study duration and for at least 18 weeks after last dose of studyintervention. 5. Women not of childbearing potential are defined as women who are either permanentlysterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or whoare postmenopausal. Women will be considered postmenopausal if they have beenamenorrhoeic for 12 months prior to signing the ICF without an alternative medicalcause. 6. Nonsterilized males who are sexually active with a female partner of childbearingpotential must comply with the methods of contraception during treatment and until theend of relevant systemic exposure in the male participant, plus a further 18 weeks. 7. Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol. 8. Written informed consent from the participant has been obtained prior to any studyrelated procedures. 9. Legally authorized representative consent has been obtained (if applicable). 10. Written documentation has been obtained in accordance with the relevant country andlocal privacy requirements, where applicable. 11. Demonstration of adequate compliance with the study procedures in Study D5271C00001 (Legacy #3150 301-008) in the opinion of the investigator and/or sponsor. 12. Willingness and ability to attend all study visits, comply with the study procedures,read and write in order to complete questionnaires, and be able to complete the study. Complete inclusion criteria are in the study protocol
Exclusion
Exclusion Criteria:
- Any participant with an unresolved AE from the Study D5271C00001 (Legacy #3150 301-008) that would limit the participant's ability to participate in or complete thisstudy.
- Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primarysclerosing cholangitis.
- Organ or cell-based transplantation (eg, islet cell transplantation or autologous stemcell transplantation) with the exception of corneal transplant.
- Any other condition or finding that, in the investigator's or sponsor's opinion, wouldeither confound proper interpretation of the study or expose a participant tounacceptable risk.
- History of cancer except for basal cell and/or squamous cell carcinoma of the skin,and carcinoma in situ of the cervix within 12 months of screening.
- Participant meets criteria for discontinuation of study intervention during prior theD5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy).
- Criterion deleted as part of Amendment.
- Known history of primary immunodeficiency, splenectomy, or any underlying conditionthat predisposes the subject to infection, including HIV infection.
- Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branchblock; determined by central ECG), or conditions leading to additional risk for QTprolongation (eg, congenital long-QT syndrome).
- Clinically significant kidney disease including but not limited to: (a) Chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml/min calculated by MDRD equation, as applicable, by the central laboratory atscreening are excluded.
- Participant requires additional immunosuppressive therapy (aside from permittedconcomitant medication), biological treatment, or prohibited treatment.
- Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 (Visit 1) or any other live vaccine < 4 weeks prior to Week 0 (Visit 1) or is planningto receive any such vaccine over the course of the study.
- Participant received a prohibited medication during participation in the lead-in studyor during screening for this study.
- Participant is planning to receive an investigational drug (other than studyintervention) or investigational device at any time during Study D5271C00002 (Legacy
#3150-303-008) with the exception of "registry" or "cohort" trials. 15. Participants with a known hypersensitivity to brazikumab or any of the excipients ofthe product. 16. Protocol-defined abnormal laboratory results at screening. 17. Females who arepregnant, nursing, or planning a pregnancy during the study OR females who are ofchildbearing potential and do not agree to use a highly effective method ofcontraception consistently and correctly.
18 Participant is directly or indirectly involved in the conduct and administration of thisstudy as an investigator, subinvestigator, study coordinator, other study staff member, oremployee of AstraZeneca, or the participant is a first-degree family member, significantother, or relative residing with one of the above persons involved directly or indirectlyin the study; or the participant is enrolled in this study at another clinical study site.
19 Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).
20 Judgment by the investigator that the participant should not participate in the study ifthe participant is unlikely to comply with study procedures, restrictions, andrequirements.
21 Previous participation in the present study. Complete exclusion criteria are in the study protocol
Study Design
Connect with a study center
Research Site
Innsbruck, 6020
AustriaSite Not Available
Research Site
St. Pölten, 3100
AustriaSite Not Available
Research Site
Steyr, 4400
AustriaSite Not Available
Research Site
Wels, 4600
AustriaSite Not Available
Research Site
New Westminster, British Columbia V3L 3W4
CanadaSite Not Available
Research Site
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Research Site
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
Research Site
Chicoutimi, Quebec G7H 5H6
CanadaSite Not Available
Research Site
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Research Site
Ceske Budejovice, 370 01
CzechiaSite Not Available
Research Site
Horovice, 26831
CzechiaSite Not Available
Research Site
Hradec Kralove, 500 12
CzechiaSite Not Available
Research Site
Olomouc, 772 00
CzechiaSite Not Available
Research Site
Ostrava, 702 00
CzechiaSite Not Available
Research Site
Usti nad Labem, 401 13
CzechiaSite Not Available
Research Site
Amiens Cedex 1, 80054
FranceSite Not Available
Research Site
Clermont Ferrand, 63003
FranceSite Not Available
Research Site
Clichy Cedex, 92118
FranceSite Not Available
Research Site
Montpellier CEDEX 5, 34295
FranceSite Not Available
Research Site
Nice, 06200
FranceSite Not Available
Research Site
Paris, 75018
FranceSite Not Available
Research Site
Reims, 51092
FranceSite Not Available
Research Site
Augsburg, 86156
GermanySite Not Available
Research Site
Berlin, 10825
GermanySite Not Available
Research Site
Hamburg, 20251
GermanySite Not Available
Research Site
Kiel, 24105
GermanySite Not Available
Research Site
Minden, 32423
GermanySite Not Available
Research Site
Remscheid, 42859
GermanySite Not Available
Research Site
Ulm, 89081
GermanySite Not Available
Research Site
Budapest, 1082
HungarySite Not Available
Research Site
Békéscsaba, 5600
HungarySite Not Available
Research Site
Debrecen, 4032
HungarySite Not Available
Research Site
Kecskemét, 6000
HungarySite Not Available
Research Site
Ahemdabad, 380054
IndiaSite Not Available
Research Site
Bangalore, 560054
IndiaSite Not Available
Research Site
Delhi, 110029
IndiaSite Not Available
Research Site
Hyderabad, 500032
IndiaSite Not Available
Research Site
Jaipur, 302001
IndiaSite Not Available
Research Site
New Delhi, 110017
IndiaSite Not Available
Research Site
Rajkot, 360004
IndiaSite Not Available
Research Site
Secunderabad, 500003
IndiaSite Not Available
Research Site
Surat, 395002
IndiaSite Not Available
Research Site
Wardha, 442004
IndiaSite Not Available
Research Site
Haifa, 3109601
IsraelSite Not Available
Research Site
Jerusalem, 9103102
IsraelSite Not Available
Research Site
Kfar Saba, 4428164
IsraelSite Not Available
Research Site
Nazareth, 16100
IsraelSite Not Available
Research Site
Petah Tikva, 4941492
IsraelSite Not Available
Research Site
Belluno, 32100
ItalySite Not Available
Research Site
Castellana Grotte, 70013
ItalySite Not Available
Research Site
Firenze, 50134
ItalySite Not Available
Research Site
Garbagnate Milanese, 20024
ItalySite Not Available
Research Site
Milano, 20154
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Padova, 35128
ItalySite Not Available
Research Site
Palermo, 90127
ItalySite Not Available
Research Site
Pavia, 27100
ItalySite Not Available
Research Site
Roma, 00157
ItalySite Not Available
Research Site
Rozzano, 20089
ItalySite Not Available
Research Site
Busan, 48108
Korea, Republic ofSite Not Available
Research Site
Daegu, 42415
Korea, Republic ofSite Not Available
Research Site
Seoul, 06591
Korea, Republic ofSite Not Available
Research Site
Wonju-si, 26426
Korea, Republic ofSite Not Available
Research Site
Białystok, 15-276
PolandSite Not Available
Research Site
Bydgoszcz, 85 168
PolandSite Not Available
Research Site
Chojnice, 89-600
PolandSite Not Available
Research Site
Karczew, 05-480
PolandSite Not Available
Research Site
Kielce, 25-355
PolandSite Not Available
Research Site
Kraków, 31-513
PolandSite Not Available
Research Site
Nowa Sól, 67-100
PolandSite Not Available
Research Site
Poznań, 61-731
PolandSite Not Available
Research Site
Rzeszow, 35-302
PolandSite Not Available
Research Site
Sopot, 81-756
PolandSite Not Available
Research Site
Szczecin, 71-434
PolandSite Not Available
Research Site
Toruń, 87-100
PolandSite Not Available
Research Site
Warszawa, 02-507
PolandSite Not Available
Research Site
Wrocław, 52-210
PolandSite Not Available
Research Site
Zamość, 22-400
PolandSite Not Available
Research Site
Aramil, 624002
Russian FederationSite Not Available
Research Site
Izhevsk, 426035
Russian FederationSite Not Available
Research Site
Kazan, 420008
Russian FederationSite Not Available
Research Site
Kemerovo, 650000
Russian FederationSite Not Available
Research Site
Krasnodar, 350072
Russian FederationSite Not Available
Research Site
Moscow, 115419
Russian FederationSite Not Available
Research Site
Novosibirsk, 630007
Russian FederationSite Not Available
Research Site
Perm, 614000
Russian FederationSite Not Available
Research Site
Saint-Petersburg, 195257
Russian FederationSite Not Available
Research Site
Tomsk, 634050
Russian FederationSite Not Available
Research Site
Banska Bystrica, 97401
SlovakiaSite Not Available
Research Site
Bratislava, 81108
SlovakiaSite Not Available
Research Site
Kosice, 04013
SlovakiaSite Not Available
Research Site
Nitra, 94901
SlovakiaSite Not Available
Research Site
Presov, 08001
SlovakiaSite Not Available
Research Site
Trnava, 917 75
SlovakiaSite Not Available
Research Site
Bloemfontein, 9301
South AfricaSite Not Available
Research Site
Cape Town, 7500
South AfricaSite Not Available
Research Site
Johannesburg, 1827
South AfricaSite Not Available
Research Site
Plumstead, 7800
South AfricaSite Not Available
Research Site
Pretoria, 0002
South AfricaSite Not Available
Research Site
Madrid, 28046
SpainSite Not Available
Research Site
Pamplona, 31008
SpainSite Not Available
Research Site
Pontevedra, 36071
SpainSite Not Available
Research Site
Sevilla, 41009
SpainSite Not Available
Research Site
Tomelloso, 13700
SpainSite Not Available
Research Site
Valencia, 46010
SpainSite Not Available
Research Site
Kaohsiung, 807
TaiwanSite Not Available
Research Site
Taichung, 40443
TaiwanSite Not Available
Research Site
Taipei, 100
TaiwanSite Not Available
Research Site
Taipei City, 114
TaiwanSite Not Available
Research Site
Kharkiv, 61037
UkraineSite Not Available
Research Site
Kharkiv Region, 61037
UkraineSite Not Available
Research Site
Kherson, 73000
UkraineSite Not Available
Research Site
Kyiv, 03680
UkraineSite Not Available
Research Site
Lviv, 79059
UkraineSite Not Available
Research Site
Ternopil, 46001
UkraineSite Not Available
Research Site
Uzhhorod, 88018
UkraineSite Not Available
Research Site
Vinnytsia, 21009
UkraineSite Not Available
Research Site
Vinnytsya, 21028
UkraineSite Not Available
Research Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Research Site
Coventry, CV2 2DX
United KingdomSite Not Available
Research Site
Nottingham, NG7 2UH
United KingdomSite Not Available
Research Site
West Bromwich, B71 4HJ
United KingdomSite Not Available
Research Site
Lincoln, California 95648
United StatesSite Not Available
Research Site
Colorado Springs, Colorado 80907
United StatesSite Not Available
Research Site
Clearwater, Florida 33756
United StatesSite Not Available
Wellness Clinical Research
Hialeah, Florida 33012
United StatesSite Not Available
Research Site
Kissimmee, Florida 34741
United StatesSite Not Available
Research Site
Lakeland, Florida 33813
United StatesSite Not Available
Research Site
Miami, Florida 33157
United StatesSite Not Available
Research Site
Miami Lakes, Florida 33016
United StatesSite Not Available
Research Site
Tampa, Florida 33626
United StatesSite Not Available
Research Site
Brownsburg, Indiana 46112
United StatesSite Not Available
Research Site
Farmington Hills, Michigan 48334
United StatesSite Not Available
Research Site
Albuquerque, New Mexico 87108
United StatesSite Not Available
Research Site
Beachwood, Ohio 44122
United StatesSite Not Available
Research Site
Houston, Texas 77058
United StatesSite Not Available
Research Site
McKinney, Texas 75071
United StatesSite Not Available
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