台灣臨床試驗主持人資料庫|TPIDB

問卷

Log In

繁中 EN

TPIDB

TPIDB Outstanding PI

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberD5272C00001 (Legacy # 3151-201-008)

2019-09-30 - 2021-07-27

Phase II

Not yet recruiting6

ICD-10K51.90

Ulcerative colitis, unspecified, without complications

ICD-10K51.911

Ulcerative colitis, unspecified with rectal bleeding

ICD-10K51.912

Ulcerative colitis, unspecified with intestinal obstruction

ICD-10K51.913

Ulcerative colitis, unspecified with fistula

ICD-10K51.914

Ulcerative colitis, unspecified with abscess

ICD-10K51.918

Ulcerative colitis, unspecified with other complication

ICD-10K51.919

Ulcerative colitis, unspecified with unspecified complications

ICD-9556.9

Ulcerative colitis, unspecified

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

Trial Applicant
Sponsor

AstraZeneca Taiwan Ltd.
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Jen-Wei Chou 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃天祐無

Tri-Service General Hospital

Co-Principal Investigator

陳保中無
謝財源無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林敬斌無

Chung Shan Medical University Hospital

Co-Principal Investigator

王賀立無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Chih Hou 無

Taipei Veterans General Hospital

Co-Principal Investigator

王彥博無
Tsung-Chieh Yang 無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Deng-Chyang Wu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Moderately to Severely Active Ulcerative Colitis

Objectives

The primary objective of this study is to evaluate the efficacy and safety of brazikumab versus placebo to induce clinical remission based on endoscopic improvement, rectal bleeding, and stool frequency scores in participants with moderate to severe UC who have failed or are intolerant to conventional therapy (5-minosalicylates, corticosteroids or immunomodulators; 6-mercaptopurine, azathioprine, methotrexate). The study population will also include participants who are biological-intervention naïve, have demonstrated a successful response to prior biological intervention, or who have failed or were intolerant to biological intervention. However, participants who have failed (met the criteria for primary or secondary nonresponse to intervention) or were intolerant to intervention with vedolizumab will be excluded from participation.

Test Drug

Brazikumab (AMG 139)

Active Ingredient

Brazikumab

Dosage Form

Solution for infusion

Dosage

70mg/vial

Endpoints

This trial will compare brazikumab with placebo to evaluate the safety and efficacy of brazikumab in improving the symptoms of UC in subjects and maintaining the improvement over time. A placebo is a similar appearance to brazikumab but does not contain any medically active drugs.
This trial will also compare brazikumab with vedolizumab (a UC drug that has been approved by the FDA and TFDA) to evaluate the safety and efficacy of brazikumab in improving subjects' UC symptoms and maintaining improvement over time compared to vedolizumab.

Inclution Criteria

• Understand the study instructions, give written informed consent and be willing and able to follow these instructions
• Be between 18 and 80 years of age (in Taiwan, all subjects participating in this study must be above 20 years old)
• Have a diagnosis of moderately to severely active Ulcerative Colitis with symptoms for at least 3 months before screening
• Have previously not responded, not responded well or were intolerant to certain medications for the treatment UC
• Not be pregnant (if you are a woman) and be willing to use recommended contraception or remain abstinent throughout the study and for 18 weeks following the last dose of study medication
• Not donate or bank egg cells or sperm for fertilization purposes throughout the study and for 18 weeks following the last dose of study medication
• Meet the tuberculosis (TB) criteria for the study
• Be willing and able to record the frequency and condition of your stool in an electronic diary on a regular basis for the duration of the study
• Undergo three colonoscopy procedures during the study starting at Screening
• Meet all of the additional relevant inclusion criteria

Exclusion Criteria

• A woman who is pregnant, nursing, or planning to become pregnant during the course of the study
• Abuse any illegal substances
• Have UC limited to the rectum, a diagnosis of Crohn’s disease or have had or require surgery for your UC
• Have taken certain medications for your UC before the Screening visit (study physician will review)
• Have previously taken vedolizumab (Entyvio) and did not respond adequately or were intolerant or had a bad reaction to it
• Received certain transfusions (such as a blood transfusion) within 30 days prior to Screening
• Received a live vaccine within 4 weeks of Baseline/Visit 2 or planning to receive such a vaccine during the course of the study
• Have had certain infections before your Screening visit or during the Screening period
• Have had a history of cancer except for certain types of skin cancers or cervical cancer that has successfully been treated
• Currently taking part in another investigational study and receiving study drug or discontinued a study drug within a specific time period (please notify the study physician if you were taking another study drug)
• A man or woman who is not willing to use contraception or remain abstinent for the time period required by the study (at screening and throughout the treatment period and safety follow-up period)

The Estimated Number of Participants

Taiwan

24 participants
Global

375 participants