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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 : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE August 7, 2018
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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)
  • 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)
  • 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
  • Presence of antibrazikumab antibodies [ Time Frame: Baseline, Weeks 6, 10, 30, 54 ]
    Detection of the presence of anti-brazikumab antibodies
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]
Official Title  ICMJE 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
Brief Summary The present study (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Colitis
  • Ulcerative
  • IBD
Intervention  ICMJE
  • Drug: Brazikumab
    Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
  • Drug: Vedolizumab
    Intravenous vedolizumab on day 1, day 15, and day 43 followed by Intravenous vedolizumab every 8 weeks beginning at day 99.
  • Drug: Placebo
    Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning at day 71.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Brazikumab
  • 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.
    Intervention: Drug: Brazikumab
  • 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.
    Intervention: Drug: Brazikumab
  • Active Comparator: Vedolizumab
    Intravenous vedolizumab on day 1, day 15, and day 43 followed by IV vedolizumab every 8 weeks beginning at day 99.
    Intervention: Drug: Vedolizumab
  • Placebo Comparator: Placebo
    Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning at day 71.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 4, 2022
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03616821
Other Study ID Numbers  ICMJE 3151-201-008
2018-001605-93 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aparna Sahoo Allergan
PRS Account Allergan
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP