Open-label Extension Study of Brazikumab in Crohn’s Disease

• Register: EUCTR
• Last refreshed on: 8 January 2024
• Main ID: EUCTR2019-001866-14-HU
• Date of registration: 02/08/2021
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: Open-label Extension Study of Brazikumab in Crohn’s Disease
• Scientific title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE)
• Date of first enrolment: 09/11/2021
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001866-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Extension study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, Czech Republic, Czechia, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Poland, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Study Information Center
• Affiliation: AstraZeneca

• Name: Clinical Study Information Center
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Inclusion criteria:
1 Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001 (Legacy # 3150-301-008).

2 No known history of active TB or latent TB without completion of appropriate intervention.

3 Each participant must have had the ileocolonoscopic procedure at the final visit (Week 52, Week 12, or early termination after Week 12 of Study D5271C00001 (Legacy # 3150-301-008).

4 Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention.

5 Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.

6 Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

7 Written informed consent from the participant has been obtained prior to any study related procedures.

8 Demonstration of adequate compliance with the study procedures in Study D5271C00001 (Legacy #3150 301-008) in the opinion of the investigator and/or sponsor.

9 Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study.

The complete list of eligibility criteria are outlined in the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion criteria:
1 Any participant with an unresolved AE from the Study D5271C00001 (Legacy #3150 301-008) that would limit the participant’s ability to participate in or complete this study.

2 Current diagnosis of ischemic colitis, colonic mucosal dysplasia, or primary sclerosing cholangitis.

3 Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.

4 Any other condition or finding that, in the investigator’s or sponsor’s opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk.

5 History of cancer except for basal cell and/or squamous cell carcinoma of the skin, and carcinoma in situ of the cervix within 12 months of screening.

6 Participant meets criteria for discontinuation of study intervention during prior the D5271C00001 (Legacy #3150 301-008) study (excluding lack of efficacy).

7 Chronic hepatitis B or C infection.

8 Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection.

9 Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined by central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome).

10 Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment, or prohibited treatment.

11 Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 (Visit 1) or any other live vaccine < 4 weeks prior to Week 0 (Visit 1) or is planning to receive any such vaccine over the course of the study.

12 Participant received a prohibited medication during participation in the lead-in study or during screening for this study.

13 Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5271C00002 (Legacy #3150-303-008) with the exception of “registry” or “cohort” trials.

14 Participants with a known hypersensitivity to brazikumab or any of the excipients of the product.

15 Protocol-defined abnormal laboratory results at screening.


The complete list of eligibility criteria are outlined in the study protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856

Intervention(s)

Product Name: Brazikumab
Product Code: MEDI2070
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BRAZIKUMAB
CAS Number: 1610353-18-8
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Product Name: Brazikumab
Product Code: MEDI2070
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BRAZIKUMAB
CAS Number: 1610353-18-8
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): a AE/SAE
b Clinical laboratory values
c Vital signs
d ECG

Main Objective: To assess the safety of long-term treatment with brazikumab in participants who previously completed Study D5271C00001 (Legacy #3150- 301-008) or discontinued from the study at or after Week 12 due to lack of efficacy.

Timepoint(s) of evaluation of this end point: a across the 52-week treatment period
b across the 52-week treatment period
c across the 52-week treatment period
d across the 52-week treatment period

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

NCT03961815

#3150-303-008

D5271C00002

111773

2019-001866-14-GB

Source(s) of Monetary Support

AstraZeneca AB

Ethics review

Status: Approved
Approval date: 02/11/2021
Contact: