Crohn DiseasePhase 1NCT02367183
A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease
A Phase 1 study testing GED-0301 in people with Crohn Disease, run by Celgene at 50 sites in 5 countries.
Trial summary
This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- GED-0301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 50 sitesin 5 countries
- Study dates
- 8 Apr 2015to 14 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male or female who is ≥18 years at the time of signing the Informed Consent Form (ICF).
- Understand and voluntarily sign an Informed Consent Form (ICF) prior to conducting any study related assessments/procedures.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Crohn's Disease (CD) with a duration of at least 3 months prior to screening.
- Diagnosis of ileitis, ileocolitis or colitis , as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI], computed tomography [CT] scan) evaluation performed within 2 years prior to screening. Subjects with colitis restricted to the left colon will not be allowed in the trial.
- Active disease, defined as Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 (range: 0 to 600) at screening.
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- Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 7 at screening. Subjects with ileitis only will require Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥ 4
- Must have failed or experienced intolerance to at least one of the following:
- aminosalicylates, budesonide, systemic corticosteroids, immunosuppressants (ie, 6 mercaptopurine [6-MP], azathioprine [AZA], or methotraxate [MTX]) or tumor necrosis factor-α tumor necrosis factor-α (TNF-α) blockers (eg, infliximab, adalimumab or certolizumab) .
- Subjects receiving oral aminosalicylates may continue their use during the study, provided that dose has been stable for at least 2 weeks prior to screening. The dose of oral aminosalicylates must remain stable through the duration of the study or early termination from the study. If oral aminosalicylates have been recently discontinued, treatment must have been stopped at least 2 weeks prior to screening.
- Subjects receiving oral corticosteroids may continue their use during the Induction Phase, provided that the dose (prednisone ≤ 20 mg/day or equivalent, budesonide ≤ 9 mg/day) has been stable for 3 weeks prior to screening. If oral corticosteroids were recently discontinued, discontinuation must have been completed at least 4 weeks prior to screening. Corticosteroid doses should remain stable until the subject is eligible to start corticosteroids tapering.
- Subjects receiving immunosuppressants, such as , 6 mercaptopurine (6-MP), azathioprine (AZA), or methotraxate (MTX) may continue their use during the study, provided that treatment was initiated ≥ 12 weeks prior to screening. The dose of immunosuppressants must be at a stable dose for ≥ 8 weeks prior to the Baseline Visit and must remain stable through the duration of the study or early termination from the study. Subjects who discontinued immunosuppressants should have stopped them at least 8 weeks prior to screening.
- Must meet the following laboratory criteria:
- White blood cell count ≥ 3000/mm3 (≥ 3.0 X 10^9//L) and < 14,000/mm3 (< 14.0 X 10^9/L)
- Platelet count ≥ 100,000/mm3 (≥ 100 X 10^9/L)
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) ≤ 2 X upper limit of normal (ULN)
- Total bilirubin ≤ 2 mg/dL (≤ 34 μmol/L) unless there is a confirmed diagnosis of Gilbert's disease
- Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
- Activated partial thromboplastin time (APTT) ≤ 1.5 X ULN
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and the Baseline Visit. While on IP and for at least 28 days after the Early Termination Visit or the end-of-study visit (Observation Week 52 or Extension Week 24), FCBP who engage in activity in which conception is possible must use 1 of the approved contraceptive options2 described below: Option 1: Any one of the following highly effective methods: hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (tying your tubes); or a partner with a vasectomy OR
- Option 2: Any two of the following effective methods: male or female condom PLUS one of the following additional barrier methods:
- diaphragm with spermicide;
- cervical cap with spermicide; or
- contraceptive sponge with spermicide
- Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on Investigational Product (IP) and for at least 28 days after the Early Termination Visit or the end-of-study visit (Observation Week 52 or Extension Week 24).
Who cannot join
- Diagnosis of Crohn's colitis restricted to the left colon , ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- Local manifestations of Crohn's Disease (CD) such as strictures, abscesses, fistula, short bowel syndrome or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy.
- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to screening.
- Subjects with an ileostomy or a colostomy.
- Stool positive for any enteric pathogen or C. difficile toxin at screening.
- History of colorectal cancer or colorectal dysplasia.
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- Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn) for the treatment of CD. In addition, prior use of any of these treatment modalities for an indication other than CD within 8 weeks of screening is also excluded.
- Use of intravenous (IV) corticosteroids within 2 weeks of screening.
- Use of topical treatment with 5 aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks of screening
- Use of antibiotic therapy for the treatment of Crohn's Disease (CD) within 3 weeks of screening.
- Use of cholestyramine within 3 weeks of screening.
- Prior treatment with more than 2 tumor necrosis factor-α (TNF-α) blockers.
- Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).
- Use of tumor necrosis factor-α (TNF-α) blockers within 12 weeks of the screening
- Administration of total parenteral nutrition (TPN) within 4 weeks of screening.
- History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would prevent the subject from participation in the study.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or breastfeeding.
- History of any of the following cardiac conditions within 6 months of screening: myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, or presence of implanted defibrillator.
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease and Herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening.
- History of congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- History of malignancy, except for:
- Treated (ie, cured) basal cell or squamous cell in situ skin carcinomas
- Treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
- Subjects who have received any investigational drug or device within 1 months of screening.
- Prior treatment with GED-0301, or participation in a clinical study involving GED-0301.
- History of alcohol, drug, or chemical abuse within the 6 months prior to screening.
- Known hypersensitivity to oligonucleotides or any ingredient in the IP.
Trial locations and contacts
50 sites in 5 countries.
50 sites in 5 countries
United States34 sites
University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Metropolitan Gastroenterology
Chevy Chase, Maryland, 20815
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 75231
Cumberland Research Associates
Fayetteville, North Carolina, 28304
Florida Research Network, LLC
Gainesville, Florida, 32605
University of Florida Shands Endoscopy Center University of Florida at Gainesville
Gainesville, Florida, 32608
Digestive Disease Consultants
Grapevine, Texas, 76051
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021
Baylor College of Medicine
Houston, Texas, 77030
Texas Digestive Disease Consultants - Southlake
Irving, Texas, 75039
Borland - Groover Clinic
Jacksonville, Florida, 32256
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Gastroenterology Group of Naples
Naples, Florida, 34102
Nashville Gastrointestinal Specialists
Nashville, Tennessee, 37211
Concorde Medical Group
New York, New York, 10016
Cornell University
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Macks Research Group
Newport Beach, California, 92660
Advanced Medical Research Center
Port Orange, Florida, 32127
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Rochester General Hospital
Rochester, New York, 14621
University of Utah Division of Gastroenterology
Salt Lake City, Utah, 84132
Medical Associates Research Group
San Diego, California, 902123
University of California, San Francisco Medical Center
San Francisco, California, 94115
University of Washington Medical Center
Seattle, Washington, 98195
Gastroenterology Specialists
Suwanee, Georgia, 30024
Montefiore Medical Center
The Bronx, New York, 10467
The Management Associates
Wilmington, North Carolina, 28403
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Medical Centre
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, 2139
Centre For Digestive Diseases
Five Dock, New South Wales, 2046
Mater Adult Hospital
South Brisbane, Queensland, 4101
Slovakia5 sites
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, 975 17
Univerzitna nemocnica Bratislava
Bratislava, 82606
IBD Centrum s.r.o.
Bratislava, 83104
KM Management, spol. s r.o.
Nitra, 949 01
GASTRO I., s.r.o.
Prešov, 080 01
Canada4 sites
London Health Science Center U. Hospital
London, Ontario, N6A 5A5
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
PerCuro Clinical Research
Victoria, British Columbia, V8V 3P9
McMaster University Medical Centre
West Hamilton, Ontario, L8N 3Z5
Hungary2 sites
Szent Imre Korhaz
Budapest, 1115
Szegedi Tudomanyegyetem
Szeged, 6720
About this study
Official title: A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.
This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
Read the detailed description
Approximately 51 subjects will be randomized in a 1:1:1 ratio to receive 1 of 3 treatment regimens in a 12-week Induction Phase:
GED-0301 160 mg Once Daily (QD) for 12 weeks GED-0301 160 mg Once Daily (QD) for 8 weeks followed by 4 weeks of placebo GED-0301 160 mg Once Daily (QD) for 4 weeks followed by 8 weeks of placebo Treatment assignment at baseline will be stratified via an Interactive Voice Response System (IVRS)/or an Interactive Web Response System (IWRS) based on previous exposure to TNF-α blockers (yes/no) and disease location (disease restricted to the terminal ileum and/or up to the mid transverse colon only, or disease involving at least 1 ulcerated segment distal to mid transverse colon). The number of subjects with previous exposure to TNF-α blockers is targeted to be approximately 40%. The number of subjects with disease involving distal to mid transverse colon is targeted to comprise approximately 50% of the study population.
The study will consist of 5 phases:
Screening Phase - up to 4 weeks Induction Phase - 12 weeks Eligible subjects will enter the Induction Phase at the Baseline Visit (Week 0/Induction Visit 1). Subjects will be assigned randomly to receive IP as described above.
At Induction Week 12, subjects (responders) who achieve clinical remission, defined as a CDAI score < 150, or clinical response, defined as a decrease from baseline of ≥ 100 points in Crohn's Disease Activity Index (CDAI) score, at any of the following Induction Visits (Weeks 4, 8 and/or Week 12) will enter the Observation Phase. The Observation Phase will have a duration of up to 52 weeks. Subjects who are unable to achieve clinical remission or clinical response (no responders) at the following Induction Visits (Weeks 4, 8 and Week 12), will be discontinued from the study. Subjects who enter the Observation Phase and were receiving corticosteroids at baseline will start tapering corticosteroids at the end of the Induction Phase (Induction Week 12).
Observation Phase - up to 52 weeks Subjects who enter the Observation Phase will be evaluated by CDAI score every 4 weeks. Subjects will not receive investigational product (IP) during the Observation Phase. Subjects who experience a partial loss of response or are unable to taper corticosteroids during the Observation Phase will enter the Extension Phase. Partial loss of response is defined as 2 consecutive visits with both a CDAI score ≥ 150 and an increase of CDAI score ≥ 50 points from the CDAI score at the visit when the subject was first a responder during the Induction Phase. Partial loss of response must be confirmed 2 to 4 weeks post initial identification of partial loss of response. Subjects who do not experience a partial loss of response until Observation Week 52 will have an end-of-study visit.
Extension Phase -24 weeks Subjects who enter the Extension Phase will receive GED-0301 40 mg QD on a 4-week, alternating dosing schedule (4 weeks of treatment with GED-0301, followed by 4 weeks without GED-0301 treatment) for 24 weeks.
Follow-up Phase - 4 weeks
Subjects who complete the Extension Week 24 Visit will have 2 options:
- Subjects will have the Follow-up Visit if they chose to not enter the Long-Term Extension Study or it has not been initiated
- Subjects may proceed to the Long-Term Extension Study, provided this study has been initiated by the time the subjects complete study GED-0301-CD-001 and subjects meet all inclusion/exclusion criteria of the Long-Term Extension Study.
Subjects who prematurely discontinue from the study, for any reason, will enter the Follow-up Phase, the 4-week period after the last study visit.
- Conditions
- Crohn Disease
- Being tested
- GED-0301, Placebo
- Keywords
- Crohn's Disease, Active Crohn's Disease, GED-0301, Endoscopic, Double-Blind, IBD, Mongersen
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GED-0301Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GED-0301 160mg QD 12 WK | Experimental | GED-0301 160 mg once daily (QD) for 12 weeks Receives: Drug: GED-0301 |
| GED-0301 160 mg QD 8 WK | Experimental | GED-0301 160 mg QD for 8 weeks followed by 4 weeks of placebo Receives: Drug: GED-0301; Drug: Placebo |
| GED-0301 160 mg QD 4 WK | Experimental | GED-0301 160 mg QD for 4 weeks followed by 8 weeks of placebo Receives: Drug: GED-0301; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SES-CD Score
The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.
Measured: Week 12
Secondary outcomes (2)
Proportion of subjects achieving a clinical remission, defined as a CDAI score < 150 at Induction Week 4
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150
Measured: Week 4
Adverse Event (AE)
Assessed by the type, frequency and severity of adverse events, and its relationship to investigational product (IP), discontinuation due to adverse events, and clinically significant changes in vital signs, Electrocardiograms (ECGs), and/or laboratory findings.
Measured: Up to 97 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start8 Apr 2015
- Primary completion6 Sep 2016
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guillermo Rossiter, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367183
- Sponsor's protocol ID
- GED-0301-CD-001
- Status last verified
- Jan 2019
- First submitted
- 13 Feb 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feagan BG, Sands BE, Rossiter G, Li X, Usiskin K, Zhan X, Colombel JF. Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease. Gastroenterology. 2018 Jan;154(1):61-64.e6. doi: 10.1053/j.gastro.2017.08.035. Epub 2017 Aug 25.
PubMed 28847751
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.
- ClinicalTrials.gov ID
- NCT02367183
- Acronym / sponsor ID
- GED-0301-CD-001
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Active Crohn's Disease, GED-0301, Endoscopic, Double-Blind, IBD, Mongersen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
Detailed description
Approximately 51 subjects will be randomized in a 1:1:1 ratio to receive 1 of 3 treatment regimens in a 12-week Induction Phase:
GED-0301 160 mg Once Daily (QD) for 12 weeks GED-0301 160 mg Once Daily (QD) for 8 weeks followed by 4 weeks of placebo GED-0301 160 mg Once Daily (QD) for 4 weeks followed by 8 weeks of placebo Treatment assignment at baseline will be stratified via an Interactive Voice Response System (IVRS)/or an Interactive Web Response System (IWRS) based on previous exposure to TNF-α blockers (yes/no) and disease location (disease restricted to the terminal ileum and/or up to the mid transverse colon only, or disease involving at least 1 ulcerated segment distal to mid transverse colon). The number of subjects with previous exposure to TNF-α blockers is targeted to be approximately 40%. The number of subjects with disease involving distal to mid transverse colon is targeted to comprise approximately 50% of the study population.
The study will consist of 5 phases:
Screening Phase - up to 4 weeks Induction Phase - 12 weeks Eligible subjects will enter the Induction Phase at the Baseline Visit (Week 0/Induction Visit 1). Subjects will be assigned randomly to receive IP as described above.
At Induction Week 12, subjects (responders) who achieve clinical remission, defined as a CDAI score < 150, or clinical response, defined as a decrease from baseline of ≥ 100 points in Crohn's Disease Activity Index (CDAI) score, at any of the following Induction Visits (Weeks 4, 8 and/or Week 12) will enter the Observation Phase. The Observation Phase will have a duration of up to 52 weeks. Subjects who are unable to achieve clinical remission or clinical response (no responders) at the following Induction Visits (Weeks 4, 8 and Week 12), will be discontinued from the study. Subjects who enter the Observation Phase and were receiving corticosteroids at baseline will start tapering corticosteroids at the end of the Induction Phase (Induction Week 12).
Observation Phase - up to 52 weeks Subjects who enter the Observation Phase will be evaluated by CDAI score every 4 weeks. Subjects will not receive investigational product (IP) during the Observation Phase. Subjects who experience a partial loss of response or are unable to taper corticosteroids during the Observation Phase will enter the Extension Phase. Partial loss of response is defined as 2 consecutive visits with both a CDAI score ≥ 150 and an increase of CDAI score ≥ 50 points from the CDAI score at the visit when the subject was first a responder during the Induction Phase. Partial loss of response must be confirmed 2 to 4 weeks post initial identification of partial loss of response. Subjects who do not experience a partial loss of response until Observation Week 52 will have an end-of-study visit.
Extension Phase -24 weeks Subjects who enter the Extension Phase will receive GED-0301 40 mg QD on a 4-week, alternating dosing schedule (4 weeks of treatment with GED-0301, followed by 4 weeks without GED-0301 treatment) for 24 weeks.
Follow-up Phase - 4 weeks
Subjects who complete the Extension Week 24 Visit will have 2 options:
- Subjects will have the Follow-up Visit if they chose to not enter the Long-Term Extension Study or it has not been initiated
- Subjects may proceed to the Long-Term Extension Study, provided this study has been initiated by the time the subjects complete study GED-0301-CD-001 and subjects meet all inclusion/exclusion criteria of the Long-Term Extension Study.
Subjects who prematurely discontinue from the study, for any reason, will enter the Follow-up Phase, the 4-week period after the last study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GED-0301 160mg QD 12 WK | Experimental | Drug: GED-0301GED-0301 160 mg once daily (QD) for 12 weeks |
| GED-0301 160 mg QD 8 WK | Experimental | Drug: GED-0301, Drug: PlaceboGED-0301 160 mg QD for 8 weeks followed by 4 weeks of placebo |
| GED-0301 160 mg QD 4 WK | Experimental | Drug: GED-0301, Drug: PlaceboGED-0301 160 mg QD for 4 weeks followed by 8 weeks of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Is a male or female who is ≥18 years at the time of signing the Informed Consent Form (ICF).
- Understand and voluntarily sign an Informed Consent Form (ICF) prior to conducting any study related assessments/procedures.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Crohn's Disease (CD) with a duration of at least 3 months prior to screening.
- Diagnosis of ileitis, ileocolitis or colitis , as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI], computed tomography [CT] scan) evaluation performed within 2 years prior to screening. Subjects with colitis restricted to the left colon will not be allowed in the trial.
Key exclusion criteria (28 listed)
- Diagnosis of Crohn's colitis restricted to the left colon , ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- Local manifestations of Crohn's Disease (CD) such as strictures, abscesses, fistula, short bowel syndrome or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy.
- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to screening.
- Subjects with an ileostomy or a colostomy.
- Stool positive for any enteric pathogen or C. difficile toxin at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GED-0301 | Drug | GED-0301 160 mg QD 4 WK, GED-0301 160 mg QD 8 WK, GED-0301 160mg QD 12 WK |
| Placebo | Drug | GED-0301 160 mg QD 4 WK, GED-0301 160 mg QD 8 WK |
Primary outcome
Change in SES-CD Score
Time frame: Week 12
The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.
2 secondary outcomes
Proportion of subjects achieving a clinical remission, defined as a CDAI score < 150 at Induction Week 4
Time frame: Week 4
Adverse Event (AE)
Time frame: Up to 97 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 28847751Feagan BG, Sands BE, Rossiter G, Li X, Usiskin K, Zhan X, Colombel JF. Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease. Gastroenterology. 2018 Jan;154(1):61-64.e6. doi: 10.1053/j.gastro.2017.08.035. Epub 2017 Aug 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Rossiter, MD study director
Celgene
50 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GED-0301 in people with Crohn Disease, run by Celgene at 50 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Australia, Slovakia, Canada, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SES-CD Score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02367183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.