Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02574637




Registration number
NCT02574637
Ethics application status
Date submitted
24/09/2015
Date registered
14/10/2015
Date last updated
26/05/2021

Titles & IDs
Public title
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
Scientific title
A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
Secondary ID [1] 0 0
2015-000609-38
Secondary ID [2] 0 0
D5170C00002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brazikumab IV Infusion
Treatment: Drugs - Brazikumab SC Injection
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.

Experimental: Brazikumab High Dose - Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Experimental: Brazikumab High-Medium Dose - Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.

Experimental: Brazikumab Low-Medium Dose - Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.

Experimental: Brazikumab Low Dose - Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.


Treatment: Drugs: Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.

Treatment: Drugs: Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.

Treatment: Drugs: Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants With Loose/Liquid Stool Frequency Response
Timepoint [1] 0 0
Baseline, Weeks 8, 16 and 28
Secondary outcome [2] 0 0
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response
Timepoint [2] 0 0
Baseline, Weeks 8, 16 and 28
Secondary outcome [3] 0 0
Percentage of Participants With CDAI Clinical Remission
Timepoint [3] 0 0
Weeks 16 and 28
Secondary outcome [4] 0 0
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response
Timepoint [4] 0 0
Baseline, Weeks 16 and 28
Secondary outcome [5] 0 0
Percentage of Participants With Loose/Liquid Stool Frequency Remission
Timepoint [5] 0 0
Baseline, Weeks 8, 16 and 28
Secondary outcome [6] 0 0
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission
Timepoint [6] 0 0
Weeks 16 and 28
Secondary outcome [7] 0 0
Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission
Timepoint [7] 0 0
Weeks 8, 16 and 28
Secondary outcome [8] 0 0
Percentage of Participants With PRO2 Response
Timepoint [8] 0 0
Baseline, Weeks 8, 16 and 28
Secondary outcome [9] 0 0
Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy
Timepoint [9] 0 0
Weeks 16 and 28
Secondary outcome [10] 0 0
Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28
Timepoint [10] 0 0
Weeks 8 and 28
Secondary outcome [11] 0 0
Serum Brazikumab Concentration
Timepoint [11] 0 0
Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4
Secondary outcome [12] 0 0
Number of Participants With Serum Anti-drug Antibodies for Brazikumab
Timepoint [12] 0 0
Predose at Weeks 0, 4, 12, 16, 28, 40 and 52
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation
Timepoint [13] 0 0
From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Secondary outcome [14] 0 0
Number of Participants With Clinically Significant Laboratory Values
Timepoint [14] 0 0
From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Secondary outcome [15] 0 0
Percentage of Participants With Abdominal Pain Response
Timepoint [15] 0 0
Baseline; Weeks 8, 16 and 28
Secondary outcome [16] 0 0
Percentage of Participants With Abdominal Pain Remission
Timepoint [16] 0 0
Weeks 8, 16 and 28

Eligibility
Key inclusion criteria
* Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior to screening
* Men or women age 18 - 80 years at the time of screening
* Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation
* Stable dose of medications for Crohn's disease therapy
* Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF a) agent
* Effective contraception from screening, and for 36 weeks after the last dose of investigational product
* No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe underlying immunosuppression
* Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
* Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization
* Recent treatment with approved or investigational biologic therapy for Crohn's disease
* Recent or planned live attenuated vaccine
* History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure = 12 months before screening
* Pregnancy/breast feeding
* Drug abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2018
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Bonheiden
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Saskatchewan
Country [23] 0 0
France
State/province [23] 0 0
Haute Garonne
Country [24] 0 0
France
State/province [24] 0 0
Ille Et Vilaine
Country [25] 0 0
France
State/province [25] 0 0
Loire
Country [26] 0 0
France
State/province [26] 0 0
Meurthe Et Moselle
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
France
State/province [28] 0 0
Saint-Priez En Jarez
Country [29] 0 0
France
State/province [29] 0 0
Toulouse Cedex 9
Country [30] 0 0
France
State/province [30] 0 0
Vandoeuvre-Les-Nancy
Country [31] 0 0
Germany
State/province [31] 0 0
Hessen
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Dortmund
Country [34] 0 0
Germany
State/province [34] 0 0
Hannover
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Israel
State/province [36] 0 0
Rechovot
Country [37] 0 0
Israel
State/province [37] 0 0
Rehovot
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Rozzano
Country [40] 0 0
Netherlands
State/province [40] 0 0
Maastricht
Country [41] 0 0
Netherlands
State/province [41] 0 0
Rotterdam
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Krasnoyarsk
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saint-Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
St. Petersburg
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
L'Hospitalet de Llobregat

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02574637