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An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition)

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ClinicalTrials.gov Identifier: NCT03616821
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The present study D5272C00001 (Legacy # 3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Colitis Ulcerative IBD Drug: Brazikumab Drug: Vedolizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : December 13, 2022
Estimated Study Completion Date : January 23, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Brazikumab Dose 1
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71
Drug: Brazikumab
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Experimental: Brazikumab Dose 2
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
Drug: Brazikumab
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Experimental: Brazikumab Dose 3
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
Drug: Brazikumab
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.

Active Comparator: Vedolizumab
Intravenous vedolizumab on day 1, day 15, and day 43 followed by IV vedolizumab every 8 weeks beginning at day 99.
Drug: Vedolizumab
Intravenous vedolizumab on day 1, day 15, and day 43 followed by Intravenous vedolizumab every 8 weeks beginning at day 99.

Placebo Comparator: Placebo
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning at day 71.
Drug: Placebo
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning at day 71.




Primary Outcome Measures :
  1. Clinical remission based on modified Mayo score (mMS) [ Time Frame: Week 10 ]
    The Modified Mayo assesses disease activity in ulcerative colitis based on 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and physician's assessment of disease activity)


Secondary Outcome Measures :
  1. Sustained clinical remission based on mMS [ Time Frame: Week 10 and Week 54 ]
    The Modified Mayo assesses disease activity in ulcerative colitis based on 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and physician's assessment of disease activity)

  2. Corticosteroid-free (CS-free) clinical remission based on mMS [ Time Frame: Week 54 ]
    The Modified Mayo assesses disease activity in ulcerative colitis based on 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and physician's assessment of disease activity)

  3. Maximum serum concentration of brazikumab (Cmax) [ Time Frame: Day 1, Day 43 ]
    Model-based derivation of the maximum serum brazikumab concentration based on population PK data

  4. Presence of antibrazikumab antibodies [ Time Frame: Baseline, Weeks 6, 10, 30, 54 ]
    Detection of the presence of anti-brazikumab antibodies

  5. Area under the serum concentration time curve (AUC) of brazikumab [ Time Frame: Days 1-14, 15-28, 29-42, 43-70 ]
    Model-based derivation of brazikumab exposure over the dosing intervals based on population PK data



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:

  • Diagnosis of UC for at least 3 months.
  • Inadequate response or intolerance to conventional therapy for the treatment of ulcerative colitis
  • Evidence of active UC based on the modified Mayo score
  • No known history of active TB
  • Agree to practicing abstinence or adhering to specific birth control requirements

Exclusion Criteria:

  • Participant has UC limited to the rectum
  • History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis specific complication of UC, including toxic megacolon
  • Previous intolerance or non-response to vedolizumab
  • Participants receiving exclusionary treatment within specified time periods
  • History of cancer, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix.
  • Clinically significant infections
  • Clinically significant cardiovascular conditions

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): NCT03616821


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Kathy Bohannon AstraZeneca
Study Director: Aparna Sahoo AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03616821    
Obsolete Identifiers: NCT04718818
Other Study ID Numbers: D5272C00001
2018-001605-93 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vedolizumab
Gastrointestinal Agents