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-IT

Lead Sponsor: ASTRAZENECA AB

Brief Summary: Not available

Detailed Description: Not available

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 (e.g.,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 part with an unresolv. AE from the lead-in st that, in the inv.'s opinion, would limit the partic's ability to partic. in or complete this st. Any unresolv. AE rel. to an infec. will require further discuss. with the st med. monit. prior to enroll.
2. Current diagn. of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, prim. sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other condit. that may potentially confound asses. must be treated prior to bas.
3. Organ or cell-based transpl. with the exc. of corneal transpl.
4. Any other condit. or finding that, in the investigator's or sponsor's opinion, would either confound proper interpr of the st or expose a part to unacc. risk.
5. The follow. are exclus. with regards to malignancy:
a) Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on biopsy.
b) Any diagn. of malignancy that requires discont. of st interv. from lead-in st.
c) Any new diagn. of malignancy after compl. of the lead-in st.
d) Carcinoma in situ of the cervix, with app. succ. cur. ther. within 12 mon. prior to W 0.
6. Part meets criteria for discont. of st interv. during prior lead-in st.
7. Chronic hepatitis B or C infec.
8. Known history of prim. immunodef., splenectomy, or any underlying condic that predisposes the part to infect., including HIV infect.
9. Prolong. QTcF int. or condit. leading to additional risk for QT prolong. Part with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolong. are to be corrected prior to enrollm.
10. Clinically signif kidney dis. incl. but not limited to:
(a) Chronic kidney dis. with an estim. glomer. filtr. rate of less than 30 ml/min calculated by Modif of Diet in Renal Disease eq.
11. Part requires additional immunosuppressive ther. (aside from permitted concom. medic. in the prot.), biologic treat. or prohibited treat.
12. Part rec. a prohibited medic. during part. in the D5272C00001 st.
13. Part rec. a Bacille Calmette-Guérin vacc. within 12 mon. of W 0 or any other live vacc. < 4 w prior to W 0, or is planning to receive any such vacc. over the course of the st.
14. Part has rec. an investig product after discont from St D5272C00001 and prior to enrolling in this st or participant is planning to receive an investig. drug (other than st interv.) or investig device at any time during St D5272C00002.
15. Part who discon. part due to lack of eff. after W 10 in St D5272C00001 and did not receive all 3 IV infus of st interv. scheduled for W 0 (D 1), W 2 (D 15), and W 6 (D 43), and SC at W 10 (D 71) in acc. with the prot. for St D5272C00001.
16. Par who discont. due to lack of eff. after W 10 in St D5272C00001 but curr. demonstrates clin resp and/or meets endosc. Mayo Score of 0-1 prior to W 54 in St D5272C00001:
Clin Resp defined as: Red in mMS = 2 p from bas AND = 30% from bas, AND a decr in the rectal bleeding score = 1 p from bas or a score of 0-1, in St D5272C00001.
Note: Part are encouraged to remain in the lead-in St D5272C00001 if the part is demonstrating evid. of clin resp. Part should not early terminate that st due to lack of eff. if this excl is met.
17. Abn. lab res. at screen. as described in the prot.
18. Females who are pregnant, breast feeding, or planning a pregnancy during the study OR females who are of childbearing potent. and do not agree to use contrac.
19. Part is dir. or indir. involved in the plan.

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 UC<br>participants who previously completed or discontinued participation due<br>to lack of efficacy after Week 10 in the lead-in Study D5272C00001<br>(Legacy #3151-201-008);Secondary Objective: Not applicable.;Primary end point(s): - AEs<br>- Clinical laboratory values<br>- Vital signs<br>- Physical exams<br>- ECGs;Timepoint(s) of evaluation of this end point: Across the 52-week treatment period for each primary endpoints

Secondary Outcome Measures

Name	Time	Method

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