| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Moderately to Severely Active Crohn’s Disease | |
| E.1.1.1 | Medical condition in easily understood language | | Crohn's disease is a condition that affects the lining of the digestive tract due to inflammation and may result in ulcers and/or strictures. | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10011402 | | E.1.2 | Term | Crohn's disease (colon) | | E.1.2 | System Organ Class | 100000004856 | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | | 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. | |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. 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 slpingectomy), 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 this 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 are outlined in the study protocol. | |
| E.4 | Principal 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 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 if 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 (applies to both AstraZeneca staff and/or staff at the study site)
20 Jugement 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 participation in the present study
The complete list of eligibility criteria are outlined in the study protocol. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | a AE/SAE
b Clinical laboratory values
c Vital signs
d Physical Exams
e ECG | |
| E.5.1.1 | 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
e across the 52-week treatment period | |
| E.5.2 | Secondary end point(s) | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description | |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 | The trial involves single site in the Member State concerned | No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 60 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | | Canada | | India | | Israel | | Korea, Republic of | | South Africa | | Taiwan | | United States | | Austria | | France | | Poland | | Spain | | Czechia | | Germany | | Italy | | Hungary | | Russian Federation | | Slovakia | | Ukraine | | United Kingdom | |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
