| Eligibility |
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):
1. Participant completed Study D5272C00001 (Legacy #3151-201-008), received scheduled
study interventions, completed scheduled visits, and completed Week 54 assessments.
2. 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.
1.02. Deleted Eligibility as part of Amendment 2 1.03. Deleted Eligibility as part of
Amendment 3 1.04. Deleted eligibility as part of Amendment 2 2.01. 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.
2.02. 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 2.03. Women
not of childbearing potential are defined as women who are either permanently sterilized
(hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are
postmenopausal.
3.01. 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.
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]).
4.01. Demonstration of adequate compliance with the study procedures in Study D5272C00001
(Legacy #3151-201-008), in the opinion of the investigator and/or sponsor.
4.02. Willingness and ability to attend all study visits, comply with the study procedures,
and be able to complete the study period.
5.01 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
Exclusion Criteria:
1.01. 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.
1.02. 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.
1.03. Organ or cell-based transplantation with the exception of corneal transplant.
1.04. 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.
1.05. The following are exclusionary with regards to malignancy:
1. Evidence of intestinal epithelial dysplasia on endoscopy, and this is confirmed on
biopsy, the participant must be excluded.
2. Any diagnosis of malignancy that requires discontinuation of study intervention from
lead-in study.
3. 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.
1.06. Participant meets criteria for discontinuation of study intervention during prior
lead-in study.
1.07. Deleted exclusion criterion as part of Amendment 3 1.08. Known history of primary
immunodeficiency, splenectomy, or any underlying condition that predisposes the participant
to infection, including HIV infection.
1.09. 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.
1.010. 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, asapplicable, by the
central laboratory at screening are excluded.
2.01. Participant requires additional immunosuppressive therapy (aside from permitted
concomitant medication in the protocol), biological treatment or prohibited treatment 2.02.
Deleted eligibility as part of Amendment 2 2.03. Participant received a prohibited
medication during participation in the D5272C00001 (Legacy #3151-201-008) study.
2.04. 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.
2.05. Participant has received an investigational product after discontinuation from Study
D5272C00001 (Legacy #3151-201-008) 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 (Legacy #3151-202-008).
3.01. 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.
3.02. Participant who discontinued due to lack of efficacy after Week 10 in Study
D5272C00001 (Legacy #3151-201-008) but currently demonstrates clinical response and/or
meets endoscopic Mayo Score of 0 or 1 prior to Week 54 in Study D5272C00001 (Legacy
#3151-201-008): Clinical Response defined as: Reduction in mMS = 2 points from baseline AND
= 30% from baseline, AND a decrease in the rectal bleeding score = 1 point from baseline or
a score of 0 or 1, in Study D5272C00001 (Legacy #3151-201-008). Note: Participants are
encouraged to remain in the lead-in Study D5272C00001 (Legacy #3151-201-008) if the
participant is demonstrating evidence of clinical response. Participants should not early
terminate that study due to lack of efficacy if this exclusion is met.
4.01. Abnormal laboratory results at screening as described in the protocol. 5.01. Females
who are pregnant, breast feeding, or planning a pregnancy during the study OR females who
are of childbearing potential and do not agree to use contraception consistently and
correctly as required by the study protocol.
5.02. Participant is directly or indirectly involved in the planning and/or conduct and
administration of this study as study staff member, or employee of the sponsor, 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.
5.03. Judgment that the participant should not participate in the study if the participant
is unlikely to comply with study procedures, restrictions, and requirements.
5.04. Previous enrollment in the present study.
Complete exclusion criteria are in the study protocol
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