A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

• Register: EUCTR
• Last refreshed on: 6 November 2017
• Main ID: EUCTR2015-001925-18-CZ
• Date of registration: 22/12/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease
• Scientific title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease
• Date of first enrolment: 01/04/2016
• Target sample size: 1064
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001925-18
• 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: yes Other: no Number of treatment arms in the trial: 4
• 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:
Diagnosis of CD with a duration of at least 3 months prior to the
Screening Visit
Presence of ileitis, ileocolitis or colitis, as determined by ileocolonoscopy
at screening.
Active disease, defined as a CDAI score = 220 and = 450 at screening
Must have a 7-day average stool frequency = 3.5 or abdominal pain =
1.5 at screening.
Must have a total SES-CD = 6 at screening, or the ileum segmental SESCD
= 4 at screening
Must have failed or experienced intolerance to at least one of the
following: budesonide; systemic corticosteroids; immunosuppressants
(ie, azathioprine [AZA], 6-mercaptopurine
[6-MP], or methotrexate [MTX]); or biologics for the treatment of CD (ie,
infliximab, adalimimumab, certolizumab or vedolizumab)
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 1010
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion criteria:
Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic
colitis, microscopic colitis, radiation colitis or diverticular diseaseassociated
colitis
Local manifestations of CD such as abscesses, short bowel syndrome; or
other disease complications for which surgery might be indicated or
could confound the evaluation of efficacy
Strictures with prestenotic dilatation, requiring procedural intervention,
or with obstructive symptoms. In addition, colonic strictures that are not
passable with an adult colonoscope, or strictures in the ileum or
ileocecal valve that are fibrotic in nature, will be excluded.
Any intestinal resection within 6 months or any intra-abdominal surgery
within 3 months prior to the Screening Visit
Prior treatment with mycophenolic acid, tacrolimus, sirolimus,
cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks
prior to the Screening Visit
Use of intravenous (IV) corticosteroids within 2 weeks prior to the
Screening Visit
Use of topical GI treatments such as 5-aminosalicylic acid (5-ASA) or
corticosteroid enemas or suppositories within 2 weeks prior to the
Screening Visit
Use of bile acid sequestrants, (eg, cholestyramine) within 3 weeks prior
to the Screening Visit
Prior treatment with biologics for the treatment of CD (approved or
investigational), other than infliximab, adalimimumab, certolizumab or
vedolizumab
Prior treatment with more than 3 biologics for the treatment of CD (ie,
infliximab, adalimimumab, certolizumab or vedolizumab). Treatment
with a biologic within 8 weeks prior to the Screening Visit, or 5
elimination half lives, whichever is longer.


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

Health Condition(s) or Problem(s) studied

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

Active Crohn's disease
MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000016693

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)

Secondary Objective: To evaluate the efficacy of GED-0301 compared with placebo on
endoscopic outcomes in subjects with active CD
To evaluate the long-term efficacy of GED-0301 compared with placebo
on clinical activity in subjects with active CD
To evaluate the efficacy of GED-0301 compared with placebo on
corticosteroid-free clinical remission in subjects with active CD
To evaluate the safety and tolerability of GED-0301 in subjects with
active CD.

Timepoint(s) of evaluation of this end point: Week 12

Primary end point(s): Efficacy as clinical remision: the proportion of subjects achieving clinical
remission defined as a CDAI score < 150, at Week 12

Main Objective: To evaluate the efficacy of GED-0301 compared with placebo on clinical
activity at Week 12 in subjects with active Crohn's disease (CD).

Secondary Outcome(s)

Secondary end point(s): Proportion of subjects achieving:
- clinical remission, defined as a CDAI score < 150, at Week 52.
- endoscopic response-50 (ER-50), defined as a reduction of at least
50% in SES-CD compared with baseline, at Week 52.
Proportion of subjects with clinical response:
- defined as a decrease from baseline in CDAI = 100 points, at Week 12.
- defined as a decrease from baseline in CDAI = 100 points, at Week 4.
Proportion of subjects:
- achieving clinical remission, defined as a CDAI score < 150, at Week 4.
- who achieve corticosteroid-free clinical remission (CDAI <150) at
Week 52 among subjects receiving oral corticosteroids for CD at
baseline.
- achieving sustained clinical remission, defined as a CDAI score < 150,
at both Week 12 and Week 52.
- with endoscopic response-25 (ER-25), defined as a reduction of at least
25% in the SES-CD compared with baseline, at Week 12.
- endoscopic remission, defined as SES-CD = 2, at Week 52.
Type, frequency, severity, seriousness, and relationship of AEs to IP.
Number of subjects who discontinue investigational product (IP) due to
any AE.
Clinically significant changes in vital signs, ECG and/or laboratory
findings.

Timepoint(s) of evaluation of this end point: as given above

Secondary ID(s)

GED-0301-CD-002

2015-001925-18-GB

Source(s) of Monetary Support

Celgene Corporation