Open-label Extension Study of Brazikumab in Crohn's Disease

Last updated: October 19, 2023
Sponsor: AstraZeneca
Overall Status: Terminated

Phase

3

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Bowel Dysfunction

Treatment

Brazikumab Induction Dose

Brazikumab Maintenance Dose

Clinical Study ID

NCT03961815
D5271C00002
2019-001866-14
#3150-303-008
  • Ages 18-80
  • All Genders

Study Summary

The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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):
  2. 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:

  1. 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.
  2. Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primarysclerosing cholangitis.
  3. Organ or cell-based transplantation (eg, islet cell transplantation or autologous stemcell transplantation) with the exception of corneal transplant.
  4. 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.
  5. 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.
  6. Participant meets criteria for discontinuation of study intervention during prior theD5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy).
  7. Criterion deleted as part of Amendment.
  8. Known history of primary immunodeficiency, splenectomy, or any underlying conditionthat predisposes the subject to infection, including HIV infection.
  9. 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).
  10. 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.
  11. Participant requires additional immunosuppressive therapy (aside from permittedconcomitant medication), biological treatment, or prohibited treatment.
  12. 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.
  13. Participant received a prohibited medication during participation in the lead-in studyor during screening for this study.
  14. 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

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Brazikumab Induction Dose
Phase: 3
Study Start date:
January 06, 2020
Estimated Completion Date:
September 19, 2023

Connect with a study center

  • Research Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Research Site

    St. Pölten, 3100
    Austria

    Site Not Available

  • Research Site

    Steyr, 4400
    Austria

    Site Not Available

  • Research Site

    Wels, 4600
    Austria

    Site Not Available

  • Research Site

    New Westminster, British Columbia V3L 3W4
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Research Site

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Research Site

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Research Site

    Ceske Budejovice, 370 01
    Czechia

    Site Not Available

  • Research Site

    Horovice, 26831
    Czechia

    Site Not Available

  • Research Site

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • Research Site

    Olomouc, 772 00
    Czechia

    Site Not Available

  • Research Site

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Research Site

    Usti nad Labem, 401 13
    Czechia

    Site Not Available

  • Research Site

    Amiens Cedex 1, 80054
    France

    Site Not Available

  • Research Site

    Clermont Ferrand, 63003
    France

    Site Not Available

  • Research Site

    Clichy Cedex, 92118
    France

    Site Not Available

  • Research Site

    Montpellier CEDEX 5, 34295
    France

    Site Not Available

  • Research Site

    Nice, 06200
    France

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  • Research Site

    Paris, 75018
    France

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  • Research Site

    Reims, 51092
    France

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  • Research Site

    Augsburg, 86156
    Germany

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  • Research Site

    Berlin, 10825
    Germany

    Site Not Available

  • Research Site

    Hamburg, 20251
    Germany

    Site Not Available

  • Research Site

    Kiel, 24105
    Germany

    Site Not Available

  • Research Site

    Minden, 32423
    Germany

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  • Research Site

    Remscheid, 42859
    Germany

    Site Not Available

  • Research Site

    Ulm, 89081
    Germany

    Site Not Available

  • Research Site

    Budapest, 1082
    Hungary

    Site Not Available

  • Research Site

    Békéscsaba, 5600
    Hungary

    Site Not Available

  • Research Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Research Site

    Kecskemét, 6000
    Hungary

    Site Not Available

  • Research Site

    Ahemdabad, 380054
    India

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  • Research Site

    Bangalore, 560054
    India

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  • Research Site

    Delhi, 110029
    India

    Site Not Available

  • Research Site

    Hyderabad, 500032
    India

    Site Not Available

  • Research Site

    Jaipur, 302001
    India

    Site Not Available

  • Research Site

    New Delhi, 110017
    India

    Site Not Available

  • Research Site

    Rajkot, 360004
    India

    Site Not Available

  • Research Site

    Secunderabad, 500003
    India

    Site Not Available

  • Research Site

    Surat, 395002
    India

    Site Not Available

  • Research Site

    Wardha, 442004
    India

    Site Not Available

  • Research Site

    Haifa, 3109601
    Israel

    Site Not Available

  • Research Site

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Research Site

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Research Site

    Nazareth, 16100
    Israel

    Site Not Available

  • Research Site

    Petah Tikva, 4941492
    Israel

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  • Research Site

    Belluno, 32100
    Italy

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  • Research Site

    Castellana Grotte, 70013
    Italy

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  • Research Site

    Firenze, 50134
    Italy

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    Garbagnate Milanese, 20024
    Italy

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    Milano, 20154
    Italy

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  • Research Site

    Napoli, 80131
    Italy

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    Padova, 35128
    Italy

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  • Research Site

    Palermo, 90127
    Italy

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    Pavia, 27100
    Italy

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  • Research Site

    Roma, 00157
    Italy

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    Rozzano, 20089
    Italy

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    Busan, 48108
    Korea, Republic of

    Site Not Available

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    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Research Site

    Wonju-si, 26426
    Korea, Republic of

    Site Not Available

  • Research Site

    Białystok, 15-276
    Poland

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  • Research Site

    Bydgoszcz, 85 168
    Poland

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  • Research Site

    Chojnice, 89-600
    Poland

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  • Research Site

    Karczew, 05-480
    Poland

    Site Not Available

  • Research Site

    Kielce, 25-355
    Poland

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  • Research Site

    Kraków, 31-513
    Poland

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  • Research Site

    Nowa Sól, 67-100
    Poland

    Site Not Available

  • Research Site

    Poznań, 61-731
    Poland

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  • Research Site

    Rzeszow, 35-302
    Poland

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  • Research Site

    Sopot, 81-756
    Poland

    Site Not Available

  • Research Site

    Szczecin, 71-434
    Poland

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  • Research Site

    Toruń, 87-100
    Poland

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    Warszawa, 02-507
    Poland

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  • Research Site

    Wrocław, 52-210
    Poland

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  • Research Site

    Zamość, 22-400
    Poland

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  • Research Site

    Aramil, 624002
    Russian Federation

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  • Research Site

    Izhevsk, 426035
    Russian Federation

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  • Research Site

    Kazan, 420008
    Russian Federation

    Site Not Available

  • Research Site

    Kemerovo, 650000
    Russian Federation

    Site Not Available

  • Research Site

    Krasnodar, 350072
    Russian Federation

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  • Research Site

    Moscow, 115419
    Russian Federation

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  • Research Site

    Novosibirsk, 630007
    Russian Federation

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  • Research Site

    Perm, 614000
    Russian Federation

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  • Research Site

    Saint-Petersburg, 195257
    Russian Federation

    Site Not Available

  • Research Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Research Site

    Banska Bystrica, 97401
    Slovakia

    Site Not Available

  • Research Site

    Bratislava, 81108
    Slovakia

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  • Research Site

    Kosice, 04013
    Slovakia

    Site Not Available

  • Research Site

    Nitra, 94901
    Slovakia

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  • Research Site

    Presov, 08001
    Slovakia

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  • Research Site

    Trnava, 917 75
    Slovakia

    Site Not Available

  • Research Site

    Bloemfontein, 9301
    South Africa

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  • Research Site

    Cape Town, 7500
    South Africa

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  • Research Site

    Johannesburg, 1827
    South Africa

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  • Research Site

    Plumstead, 7800
    South Africa

    Site Not Available

  • Research Site

    Pretoria, 0002
    South Africa

    Site Not Available

  • Research Site

    Madrid, 28046
    Spain

    Site Not Available

  • Research Site

    Pamplona, 31008
    Spain

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  • Research Site

    Pontevedra, 36071
    Spain

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  • Research Site

    Sevilla, 41009
    Spain

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  • Research Site

    Tomelloso, 13700
    Spain

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  • Research Site

    Valencia, 46010
    Spain

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  • Research Site

    Kaohsiung, 807
    Taiwan

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    Taichung, 40443
    Taiwan

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  • Research Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 114
    Taiwan

    Site Not Available

  • Research Site

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Research Site

    Kharkiv Region, 61037
    Ukraine

    Site Not Available

  • Research Site

    Kherson, 73000
    Ukraine

    Site Not Available

  • Research Site

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Research Site

    Lviv, 79059
    Ukraine

    Site Not Available

  • Research Site

    Ternopil, 46001
    Ukraine

    Site Not Available

  • Research Site

    Uzhhorod, 88018
    Ukraine

    Site Not Available

  • Research Site

    Vinnytsia, 21009
    Ukraine

    Site Not Available

  • Research Site

    Vinnytsya, 21028
    Ukraine

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Research Site

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Research Site

    West Bromwich, B71 4HJ
    United Kingdom

    Site Not Available

  • Research Site

    Lincoln, California 95648
    United States

    Site Not Available

  • Research Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Research Site

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Wellness Clinical Research

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Research Site

    Lakeland, Florida 33813
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33157
    United States

    Site Not Available

  • Research Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33626
    United States

    Site Not Available

  • Research Site

    Brownsburg, Indiana 46112
    United States

    Site Not Available

  • Research Site

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • Research Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77058
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75071
    United States

    Site Not Available

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