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Open-label Extension Study of Brazikumab in Crohn's Disease (INTREPID OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961815
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2019
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease IBD Drug: Brazikumab Induction Dose Drug: Brazikumab Maintenance Dose Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 161 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : April 14, 2025
Estimated Study Completion Date : April 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Brazikumab Induction Dose
Administer at Week 0, Week 4, and Week 8
Drug: Brazikumab Induction Dose
Participants who have not responded to treatment and have met criteria for rescue therapy prior to Week 52 in the lead-in study D5271C00001 (Legacy #3150-301-008) are considered inadequate/non responders, and will receive intravenous induction dosing with brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab subcutaneously every 4 weeks thereafter up to Week 52.

Experimental: Brazikumab Maintenance Dose
Administer at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52
Drug: Brazikumab Maintenance Dose
Responders and completers in the lead-in study D5271C00001 (Legacy #3150-301-008) will receive maintenance dose of brazikumab administered subcutaneously every 4 weeks through Week 52, starting at Week 0. The subcutaneous dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered.




Primary Outcome Measures :
  1. Number and percentage of patients with adverse events [ Time Frame: through Week 70 ]
    Number and percentage of patients with reported adverse events.

  2. Percentage of patients with potentially clinically significant changes in laboratory values [ Time Frame: through Week 70 ]
    Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.

  3. Percentage of patients with potentially clinically significant changes in vital signs [ Time Frame: through Week 70 ]
    Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.

  4. Percentage of patients with potentially clinically significant changes in ECGs [ Time Frame: through Week 70 ]
    Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008).

    Meets 1 of the following criteria for successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy #3150-301-008):

    1. 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 from the study due to lack of efficacy after a minimum of 12 weeks of double-blind treatment and meets criteria for the use of rescue treatment and/or worsening disease in the lead-in protocol.
  2. No known history of active TB or latent TB without completion of appropriate intervention. Participant also must meet acceptable TB test results from the central laboratory at baseline.
  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 pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention.
  5. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause.
  6. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
  7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  8. Written informed consent from the participant has been obtained prior to any study related procedures.
  9. Legally authorized representative consent has been obtained (if applicable).
  10. Written documentation has been obtained in accordance with the relevant country and local 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 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 this study.
  2. Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primary sclerosing cholangitis.
  3. Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
  4. Any other condition or finding that, in the investigator's or sponsor's opinion, would either confound proper interpretation of the study or expose a participant to unacceptable 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 the D5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy).
  7. Chronic hepatitis B or C infection.
  8. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection.
  9. Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined by central ECG), or conditions leading to additional risk for QT prolongation (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 at screening are excluded.

  11. Participant requires additional immunosuppressive therapy (aside from permitted concomitant 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 planning to receive any such vaccine over the course of the study.
  13. Participant received a prohibited medication during participation in the lead-in study or during screening for this study.
  14. Participant is planning to receive an investigational drug (other than study intervention) 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 of the product.
  16. Protocol-defined abnormal laboratory results at screening. 17. Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly.

18 Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of AstraZeneca, or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in 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 AstraZeneca staff and/or staff at the study site).

20 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

21 Previous participation in the present study.

Complete exclusion criteria are in the study protocol


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961815


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Kathy Bohannon AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03961815    
Other Study ID Numbers: D5271C00002
2019-001866-14 ( EudraCT Number )
#3150-303-008 ( Other Identifier: Legacy )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases