Open-label Extension Study of Brazikumab in Crohn’s Disease
- Conditions
- Moderately to Severely Active Crohn’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-001866-14-PL
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1 Male or female participants with successful completion or early
termination due to lack of efficacy from Study D5271C00001 (Legacy #
3150-301-008).
2. Criterion deleted.
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 signing the ICF throughout the study duration
and for at least 18 weeks after last dose of study intervention.
5 Women not of childbearing potential are defined as women who are
either permanently sterilized (hysterectomy, bilateral oophorectomy, or
bilateral salpingectomy), or who are postmenopausal.
6 Nonsterilized males who are sexually active with a female partner of
childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a
further 18 weeks.
7 Capable of giving signed informed consent which includes compliance
with the requirements and restrictions listed in the ICF and in study
protocol.
8 Written informed consent from the participant has been obtained prior
to any study related procedures.
9. Criterion not included because it is not applicable.
10 Written documentation has been obtained in accordance with the
relevant country and local privacy requirements, where applicable
11 Demonstration of adequate compliance with the study procedures in
Study D5271C00001 (Legacy #3150 301-008) in the opinion of the
investigator and/or sponsor.
12 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 is 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 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
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 Criterion deleted
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 Clinically significant kidney disease including but not limited to:
(a) Chronic kidney disease with an estimated glomerular filtration rate
of less than 30 ml/min calculated by MDRD equation, as applicable, by
the central laboratory at screening are excluded
11 Participant requires additional immunosuppressive therapy (aside
from permitted concomitant medication), biological treatment, or
prohibited treatment.
12 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.
13 Participant received a prohibited medication during participation in
the lead-in study or during screening for this study.
14 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.
15 Participants with a known hypersensitivity to brazikumab or any of
the excipients of the product.
16 Protocol-defined abnormal laboratory results at screening.
17 Females who are pregnant, nursing, or planning a pregnancy during
the study OR females who are of childbearing potential and do not agree
to use a highly effective method of contraception consistently and
correctly
18 Participant is directly or indirectly involved in the conduct and
administration of this study as an investigator, subinvestigator, study
coordinator, other study staff member, or employee of AstraZeneca, or
the participant is a first-degree family member, significant other, or
relative residing with one of the above persons involved directly or
indirectly in the study; or the participant is enrolled in this study at
another clinical study site.
19 Involvement in the planning and/or conduct of the study (applies to
both AstraZeneca staff and/or staff at the study site).
20 Judgment by the investigator that the participant should not
participate in the study if the participant is unlikely to comply with study
procedures, restrictions, and requirements.
21 Previous partici
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Secondary Objective: Not applicable;Primary end point(s): a) AE/SAE<br>b) Clinical laboratory values<br>c) Vital signs<br>d) Physical Exams<br>e) ECG;Timepoint(s) of evaluation of this end point: a) across the 52-week treatment period<br>b) across the 52-week treatment period<br>c) across the 52-week treatment period<br>d) across the 52-week treatment period<br>e) across the 52-week treatment period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable