Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
30 June 2019 |
Main ID: |
EUCTR2015-001963-37-HR |
Date of registration:
|
21/06/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
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:
|
05/05/2016 |
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: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different dose of regimen of the study treatment 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
|
Bosnia and Herzegovina
|
Brazil
|
Bulgaria
|
Canada
|
Chile
|
Colombia
|
Croatia
|
Czech Republic
|
Denmark
|
Estonia
|
Finland
|
France
|
Germany
|
Greece
|
Hungary
|
Israel
|
Italy
|
Korea, Republic of
|
Latvia
|
Malaysia
|
Mexico
|
Netherlands
|
New Zealand
|
Norway
|
Poland
|
Portugal
|
Romania
|
Russian Federation
|
Serbia
|
Slovakia
|
South Africa
|
Spain
|
Sweden
|
Switzerland
|
Taiwan
|
Turkey
|
Ukraine
|
United Kingdom
|
United States
| | | | | | |
Contacts
|
Name:
|
ClinicalTrialDisclosure
|
Address:
|
9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
|
+18882601599 |
Email:
|
ClinicalTrialDisclosure@celgene.com |
Affiliation:
|
Celgene Corporation |
|
Name:
|
ClinicalTrialDisclosure
|
Address:
|
9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
|
+18882601599 |
Email:
|
ClinicalTrialDisclosure@celgene.com |
Affiliation:
|
Celgene Corporation |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Inclusion Criteria for Adult Subjects:
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 the Week 12 Visit in the core
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 beginning at the
Week 12 Visit 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).FCBP must
either practice true abstinence from heterosexual contact or use one of
the options while on IP and for at least 28 days after taking last dose of
IP.
Inclusion Criteria for Adolescent Subjects:
1. male or female, 12 to 17 years of age at the time of assent/informed
consent in core GED-0301-CD-003 study and must affirmatively
agree to participate in this study by signing an assent with a
parent/legal guardian who can understand and voluntarily sign an ICF.
Adolescent subjects who turn 18 by the screening visit for GED-0301-CD-
004 study must also understand and voluntarily sign an ICF prior to any
study-related assessments/procedures being conducted.
2. able to swallow the IP tablets.
3. willing and able to adhere to study visit schedule and protocol
requirements, and a parent or legal guardian willing to supervise
adherence to protocol requirements.
4. must have completed through the Week 12 Visit in Study GED-0301-
CD-003.
5. Females of childbearing potential (FCBP)5 must have a negative
pregnancy test at screening and enrollment (Visits 1 and 2). FCBP must
either practice true abstinence from heterosexual contact or use one of
the approved contraceptive options while on IP and for at least 28 days
after taking the last dose of IP. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1243 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 core Phase 3 GED-0301 study.
2. Subject has any continuing serious medical condition, laboratory
abnormality, or psychiatric illness that occurred while participating in
the core 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 while, or after participating in the core Phase 3
GED-0301 study.
5. Subject diagnosed with colorectal cancer or confirmed diagnosis of
colorectal dysplasia (with the exception of adenomatous colonic polyps
that have been completely resected) while participating in the core
Phase 3 GED-0301 study.
6. newly diagnosed malignancy while participating in the previous Phase
3 GED-0301 study.
7. pregnant or breastfeeding.
8. Subject has been newly diagnosed with substance abuse.
9. New condition that may put subject at risk or confound the ability to
interpret data from the study.
9. 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: 20.0
Level: LLT
Classification code 10021315
Term: Ileitis terminal
System Organ Class: 100000016693
|
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
|
Intervention(s)
|
Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated 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: Film-coated tablet Route of administration of the placebo: Oral use
|
Primary Outcome(s)
|
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
|
Main Objective: To evaluate the long-term safety of oral GED-0301 in subjects with Crohn’s disease
|
Secondary Objective: Secondary Objectives (Adolescent Subjects): English - evaluate the efficacy of GED-0301 on clinical activity - evaluate long-term endoscopic outcomes of GED-0301 - evaluate the long-term changes in linear growth in response to GED- 0301
|
Timepoint(s) of evaluation of this end point: Through Week 208 and 4 weeks postdose
|
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 endpoints for Adolescents subjects from GED-0301-CD-003:
- The proportion of subjects with clinical remissiona at Week 40.
- The proportion of subjects with endoscopic remission defined as SESCD
= 2 at Week 40
- The proportion of subjects who have clinical remissiona, defined as a
PCDAI = 10 points at Week 40.
- The change from baseline (GED-0301-CD-003) in weight, height, body
mass index (BMI), and height velocity z-scores (adjusted for
chronological age) at Week 40
|
Secondary ID(s)
|
2015-001963-37-LV
|
GED-0301-CD-004
|
Source(s) of Monetary Support
|
Celgene Corporation
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|