| 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 disease that causes the intestines to become swollen and may develop ulcers | |
| 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 CD participants who previously completed studies 3150-301-008 or 3150-302-008, or discontinued from Study D5170C00002 due to its termination, or discontinued from Study 3150-301-008 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 | - Male or female participants with successful completion or early termination due to lack of efficacy from Study 3150-301-008, 3150-302-008, or discontinuation from therapy due to termination of Study D5170C00002.
- No prior history of active TB and meets all TB-related criteria as defined in more detail in the protocol.
- Each participant must have had the ileocolonoscopic procedure at the final visit of the lead-in study (either 3150-301-008 or 3150-302-008), no greater than 28 days before baseline of this study, or must consent to having one performed prospectively at baseline in this study. In the case of participants from Study D5170C00002, participants must consent to having one performed at baseline (Visit 1) and again at Week 52 (Visit 14) to be eligible for participation.
- Agree to comply with contraception requirements as defined in more detail in the protocol.
- Study participants must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period as defined in more detail in the protocol.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Written informed consent from the participant has been obtained prior to any study-related procedures.
- Legally authorized representative consent has been obtained (if applicable).
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
- Demonstration of adequate compliance with the study procedures in Study 3150-301-008, 3150-302-008, or D5170C00002, in the opinion of the investigator and/or sponsor.
- 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 period. | |
| E.4 | Principal exclusion criteria | - Any participant with an unresolved AE from a lead-in study, (i.e., a clinically significant finding on physical examination, clinical laboratory test, or 12-lead ECG [including QTc prolongation]) that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete the study. Any unresolved AE related to an infection will require further discussion with the study medical monitor.
- Current diagnosis of ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or any demyelinating condition. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline.
- Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
- 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, including but not limited to clinically significant findings on physical examination, clinical laboratory test, 12-lead ECG (including QTc prolongation), or clinically significant renal, hepatic, or cardiopulmonary disease.
- History of cancer with the exceptions listed in detail under criterium 1.05.
- Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment or prohibited treatment.
- Participant received a Bacille Calmette-Guérin vaccination within 12 months of baseline (Visit 1) or any other live vaccine < 4 weeks prior to baseline (Visit 1). Participant agrees to refrain from receiving live vaccines during the course of the study.
- Participant receives a prohibited medication during participation in the study or during screening for this study.
- Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3150-303-008.
- Abnormal laboratory results at baseline as defined more detail in the protocol.
- 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.
- Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, sub-investigator, study coordinator, other study staff member, or employee of Allergan, 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. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | - AEs
- Clinical laboratory values
- Vital signs
- ECGs | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | - AE/SAE assessment: Assessed at Baseline & at 4-week intervals through week 52
- Clinical laboratory values:
Serum chemistry, hematology, and CRP: Baseline, Week 12, Week 24, Week 36, Week 52
HbA1c, FCP (stool): Baseline, Week 24, Week 52
Urinalysis: Baseline, Week 52
Pregnancy test: Baseline, at 4-week intervals through week 52
- Vital signs: All vital signs (e.g. BP, Temperature) should be collected prior to, and immediately following, dosing and recorded on the eCRF.
- ECG: Baseline, Week 52 | |
| 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 | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| 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 | 1 |
| 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 | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 180 |
| 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 | | Australia | | Austria | | Belgium | | Bulgaria | | Canada | | China | | Czechia | | France | | Germany | | Hungary | | India | | Israel | | Italy | | Korea, Republic of | | Poland | | Romania | | Russian Federation | | South Africa | | Spain | | Taiwan | | Ukraine | | United Kingdom | | United States | |
| 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 |
