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A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease
This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease
Subjects will be screened to provide 20 enrolled subjects who complete 12 weeks of mongersen (GED-0301) 160 mg QD treatment as open-label therapy. The study will consist of 4 periods: * Screening Period - up to 4 weeks * Induction Period - 12 weeks (Week 0 Visit through Week 12 Visit) * Maintenance Period - 88 weeks (after Week 12 Visit through Week 100 Visit) * Follow-up Period - 4 weeks (ie, no IP taken) Subjects who prematurely discontinue treatment from this study prior to Week 100 will have an Early Termination Visit and also enter the 4-week Follow-up Period. At the Screening Visit, all subjects who meet the entrance criteria will be eligible to enter the study. The number of subjects with previous exposure to Tumor Necrosis Factor-Alpha (TNF-α) blockers is targeted to be approximately 40% (ie, approximately 8 subjects).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Policlinico Tor Vergata
Rome, Italy
Start Date
April 4, 2016
Primary Completion Date
September 25, 2017
Completion Date
November 9, 2017
Last Updated
August 14, 2018
18
ACTUAL participants
GED-0301
DRUG
Lead Sponsor
Celgene
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06918808