A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
Overview
- Phase
- Phase 2
- Intervention
- Brazikumab Maintenance Dose
- Conditions
- Ulcerative Colitis
- Sponsor
- AstraZeneca
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Number and percentage of patients with adverse events
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.01 Male or female participants who: successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001 (Legacy #3151-201-008). AND Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001 (Legacy #3151-201-008):
- •Participant completed Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments.
- •Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 (Legacy #3151-201-008), received scheduled study interventions, and completed Early Termination Visit assessments.
- •Deleted Eligibility as part of Amendment 2 1.
- •Deleted Eligibility as part of Amendment 3 1.
- •Deleted eligibility as part of Amendment 2 2.
- •Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Nonsterilized men who are sexually active with a female partner of childbearing potential should use condom during treatment and for 18 weeks after the last dose of study intervention, must comply with the methods of contraception described in Criterion 2.02 below, and must not donate or bank sperm for fertilization purpose for the same time period.
- •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 2.
- •Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria
- •Any participant with an unresolved AE from the lead-in study that, in the investigator's opinion, would limit the participant's ability to participate in or complete this study. Any unresolved AE related to an infection will require further discussion with the study physician/designee prior to enrollment.
- •Current diagnosis of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline.
- •Organ or cell-based 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.
- •The following are exclusionary with regards to malignancy:
- •Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy, the participant must be excluded.
- •Any diagnosis of malignancy that requires discontinuation of study intervention from lead-in study.
- •Any new diagnosis of malignancy after completion of the lead-in study. d) Carcinoma in situ of the cervix, with apparent successful curative therapy within 12 months prior to Week
- •Participant meets criteria for discontinuation of study intervention during prior lead-in study.
- •Deleted exclusion criterion as part of Amendment 3 1.
Arms & Interventions
Brazikumab Maintenance Dose
Administer at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52
Intervention: Brazikumab Maintenance Dose
Brazikumab Induction Dose
Administer at Week 0, Week 4, and Week 8
Intervention: Brazikumab Induction Dose
Outcomes
Primary Outcomes
Number and percentage of patients with adverse events
Time Frame: Through week 70
Number and percentage of patients with reported adverse events.
Percentage of patients with potentially clinically significant changes in laboratory values
Time Frame: Through week 70
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Percentage of patients with potentially clinically significant changes in vital signs
Time Frame: Through week 70
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Percentage of patients with potentially clinically significant changes in physical exams
Time Frame: Through week 70
Percentage of patients with potentially clinically significant changes in full physical exams.
Percentage of patients with potentially clinically significant changes in ECGs
Time Frame: Through week 70
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings.