A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease

• Register: EUCTR
• Last refreshed on: 5 March 2018
• Main ID: EUCTR2015-001963-37-PT
• Date of registration: 10/02/2016
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease
• Scientific title: A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease
• Date of first enrolment: 28/03/2016
• Target sample size: 1414
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001963-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is a male or female = 18 years of age at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject must have completed through Week 12 in the previous GED-0301 study AND either:
Completed participation through the last study treatment visit
at Week 52 in Study GED-0301-CD-002 or at Week 12 in Study GED-0301-CD-003 OR Met the “early escape criteria” and were discontinued after Week 12 in Study GED-0301-CD-002.
5. Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and enrollment (Visits 1 and 2). While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options
6. Male subjects when engaging in sexual activity with females who are able to become pregnant must use barrier contraception while on IP and for at least 28 days after the last dose.
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 1343
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71

Exclusion criteria:
1. Subject had experienced a serious adverse event related to the IP while participating in the previous Phase 3 GED-0301 study.
2. Subject has any continuing serious medical condition, laboratory abnormality, or psychiatric illness that occurred while participating in the previous Phase 3 GED-0301 study.
3. Subject has or had a flare or worsening of CD that, in the opinion of the Investigator, would not be in the best interest for the subject to participate in this long-term active treatment study.
4. Subject has initiated biologic agents, such as TNF-a blockers or integrin antagonists.
5. Subject has been diagnosed with colorectal cancer or colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected) while participating in the previous Phase 3 GED-0301 study.
6. Subject has a newly diagnosed malignancy while participating in the previous Phase 3 GED-0301 study.
7. Subject is pregnant or breastfeeding.
8. Subject has been newly diagnosed with substance abuse.
9. Subject has developed a known hypersensitivity to oligonucleotides, GED-0301 or any ingredient in the IP.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Crohn's disease
MedDRA version: 18.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Mongersen
Product Code: GED-0301
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: mongersen
CAS Number: 1443994-98-6
Current Sponsor code: GED-0301
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Through Week 208 and 4 weeks postdose

Main Objective: To evaluate the long-term safety of oral GED-0301 in subjects with Crohn’s disease

Primary end point(s): Safety of GED-0301, assessed by type, frequency and severity of adverse events, and its relationship to investigational product, discontinuation due to adverse events, and clinically significant changes in electrocardiograms (ECGs), vital signs, and/or laboratory findings

Secondary Objective: Secondary objectives are not included in this study.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: not applicable

Secondary end point(s): Secondary endpoints are not included in this study.

Secondary ID(s)

GED-0301-CD-004

2015-001963-37-LV

Source(s) of Monetary Support

Celgene Corporation