Extension Study of APD334-003 in Patients with Ulcerative Colitis
Research type
Research Study
Full title
An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis
IRAS ID
191848
Contact name
James Lindsay
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc.
Eudract number
2015-002109-12
Duration of Study in the UK
1 years, 6 months, 12 days
Research summary
This protocol has been designed as an extension study to help determine the long-term safety and tolerability of APD334 in patients with ulcerative colitis who have completed the 12-week phase 2 study, APD334-003. To be eligible, patients must have
completed the APD334-003 study and must meet eligibility criteria for APD334-005 at time of entry.All patients who have completed the APD334-003 induction study (responders and non-responders) and who meet the eligibility criteria for the APD334-005 extension study will have the option to enroll. For this purpose, all patients shall be consented for APD334-005 prior to the final procedures being performed for APD334-003. The
dose administered will depend upon the patient’s responder status
from the APD334-003 study.• Eligible responders on active treatment from the APD334-003
study (who choose to continue on to the APD334-005 study) will
undergo 1:1 re-randomization to 2 mg APD334 q.d. or matching
placebo, for up to 40 additional weeks (a total of up to 52 weeks
between the two studies) or until they experience a clinical flare.
Placebo responders will remain on placebo. All eligible
responders will remain blinded.
• Non-responders from the APD334-003 study (who choose to
continue on to the APD334-005 study) will be administered
open-label treatment with APD334 at 2 mg q.d. for up to 40
weeks.
• Responders from the APD334-003 study who transition to the APD334-005 extension study and after enrolling, experience a
clinical flare, have the option to either convert to open-label
treatment (2 mg APD334 q.d.) for the remainder of the 40
weeks/early discontinuation or discontinue from the study (see
Section 7.2).Select procedures from the Week 12 visit in study APD334-003 will be carried over to the APD334-005 study to be included as baseline information for certain analyses. All patients who transition into the extension study will have their heart rate and rhythm recorded by Holter monitoring for -24 hours pre-initial-dose through 24 hours
post-dose and will remain onsite for at least 8 hours after first dose of study medication to receive hourly vital sign and ECG measurements. For patients who subsequently experience a clinical flare in the APD334-005 extension study and choose to convert to open-label treatment with 2 mg APD334, vital signs will be monitored using a Holter monitor for -24 hours pre-dose through 24 hours post dose on the first day of open-label treatment. In addition, these patients will be observed at the clinic site for 8 hours post- first open-label dose to monitor their heart rate, blood pressure, and allow for PK blood draws (see Section 7.2). Final assessments will be conducted at Week 52 from baseline of Study APD334-003 (Week 40 of this study) or upon early termination from the study. A 2 week follow-up visit will be
conducted to ensure appropriate patient safety.REC name
London - South East Research Ethics Committee
REC reference
16/LO/0125
Date of REC Opinion
14 Mar 2016
REC opinion
Further Information Favourable Opinion