Open-label Extension Study of Brazikumab in Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-001644-10-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-15
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Male or female participants who:
1.successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001.
AND
Meets 1 of the following criteria for successful completion or early termination from Study D5272C00001:
(a)Participant completed Study D5272C00001, received scheduled study interventions, completed scheduled visits, and completed Week 54 assessments.
(b)Participant discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001, received scheduled study interventions, and completed Early Termination Visit assessments.
2.No known history of active TB or latent TB without completion of appropriate intervention.
3.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
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.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.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.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]).
9.Demonstration of adequate compliance with the study procedures in Study D5272C00001, in the opinion of the investigator and/or sponsor.
10.Willingness and ability to attend all study visits, comply with the study procedures, and be able to complete the study period.
11.Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF.
Complete inclusion criteria are 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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.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 medical monitor prior to enrollment.
2.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.
3.Organ or cell-based 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.The following are exclusionary with regards to malignancy:
a)Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy, the participant.
b)Any diagnosis of malignancy that requires discontinuation of study intervention from lead-in study.
c)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 0.
6.Participant meets criteria for discontinuation of study intervention during prior lead-in study.
7.Chronic hepatitis B or C infection
8.Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, including HIV infection.
9.Prolonged QTcF interval or conditions leading to additional risk for QT prolongation. Participants with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolongation are to be corrected prior to enrollment.
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 Modification of Diet in Renal Disease equation.
11.Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication in the protocol), biological treatment or prohibited treatment
12.Participant received a prohibited medication during participation in the D5272C00001 study.
13.Participant received a Bacille Calmette-Guérin vaccination within 12 months of Week 0 or any other live vaccine < 4 weeks prior to Week 0, or is planning to receive any such vaccine over the course of the study.
14.Participant has received an investigational product after discontinuation from Study D5272C00001 and prior to enrolling in this study or participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study D5272C00002.
15.Participant who discontinued participation due to lack of efficacy after Week 10 in Study D5272C00001 and did not receive all 3 IV infusions of study interventions scheduled for Week 0 (Day 1), Week 2 (Day 15), and Week 6 (Day 43), and SC at Week 10 (Day 71) in accordance with the protocol for Study D5272C00001.
16.Participant who discontinued due to lack of efficacy after Week 10 in Study D5272C00001 but currently demonstrates clinical response and/or meets endoscopic Mayo Score of 0 or 1 prior to Week 54 in Study D5272C00001:
Clinical Response defined as:

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified