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

Ulcerative Colitis Clinical Trial

— Expedition  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718818
• Other study ID #: D5272C00001
• Secondary ID: 2018-001605-93
• Status: Recruiting
• Phase: Phase 2
• Start date: August 7, 2018
• Est. completion date: September 11, 2023

Study information

• Verified date: January 2021
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 11, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Brazikumab
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning at day 71.
• Vedolizumab
Intravenous vedolizumab on day 1, day 15, and day 43 followed by Intravenous vedolizumab every 8 weeks beginning at day 99.
• Placebo
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning at day 71.

Locations

Country	Name	City	State
Canada	Research Site	Vaughan	Ontario
India	Research Site	Ahemdabad
India	Research Site	Bangalore
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Jaipur
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Rajkot
India	Research Site	Secunderabad
India	Research Site	Surat
India	Research Site	Wardha
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Wonju-si
Puerto Rico	Research Site	San Juan
Romania	Research Site	Cluj Napoca
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei City
United States	Research Site	Amarillo	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Beachwood	Ohio
United States	Research Site	Biloxi	Mississippi
United States	Research Site	Biloxi	Mississippi
United States	Research Site	Brownsburg	Indiana
United States	Research Site	Carrollton	Texas
United States	Research Site	Chula Vista	California
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Decatur	Georgia
United States	Research Site	Evansville	Indiana
United States	Research Site	Gurnee	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntington	West Virginia
United States	Research Site	Kissimmee	Florida
United States	Research Site	Lakeland	Florida
United States	Research Site	Lancaster	California
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lincoln	California
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Marrero	Louisiana
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami Lakes	Florida
United States	Research Site	Morehead City	North Carolina
United States	Research Site	New Port Richey	Florida
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Ocoee	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Pflugerville	Texas
United States	Research Site	Poway	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Shawnee Mission	Kansas
United States	Research Site	Spokane	Washington
United States	Research Site	Spring	Texas
United States	Research Site	Springfield	Ohio
United States	Research Site	Sunnyside	New York
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Topeka	Kansas
United States	Research Site	Tucson	Arizona
United States	Research Site	Uniontown	Pennsylvania
United States	Research Site	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  India,  Korea, Republic of,  Puerto Rico,  Romania,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission based on modified Mayo score (mMS)	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)	Week 10
Secondary	Sustained clinical remission based on mMS	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)	Week 10 and Week 54
Secondary	Corticosteroid-free (CS-free) clinical remission based on mMS	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)	Week 54
Secondary	Maximum serum concentration of brazikumab (Cmax)	Model-based derivation of the maximum serum brazikumab concentration based on population PK data	Day 1, Day 43
Secondary	Presence of antibrazikumab antibodies	Detection of the presence of anti-brazikumab antibodies	Baseline, Weeks 6, 10, 30, 54
Secondary	Area under the serum concentration time curve (AUC) of brazikumab	Model-based derivation of brazikumab exposure over the dosing intervals based on population PK data	Days 1-14, 15-28, 29-42, 43-70