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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
A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFa) therapy.
Trial website
https://clinicaltrials.gov/study/NCT02574637
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02574637