Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02685683
• Date of registration: 15/02/2016
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease
• Scientific title: A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease
• Date of first enrolment: April 4, 2016
• Target sample size: 18
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02685683
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Keith Usiskin, MD
• Affiliation: Celgene

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female = 18 years of age.

- Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity
Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)

- Subject must have failed or experienced intolerance to at least one of the following:
budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine,
6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

- Subject must use protocol approved contraception

Exclusion Criteria:

- Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
microscopic colitis, radiation colitis or diverticular disease-associated colitis

- Crohn's Disease (CD) manifestations such as abscesses, short bowel syndrome; or
intestinal strictures with prestenotic dilatation, requiring procedural intervention
or not passable with an adult colonoscope.

- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months
prior to the Screening Visit

- Ileostomy or a colostomy

- Prior treatment with more than 2 TNF-a blockers (eg, infliximab or adalimumab).

- Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).

- Subject is pregnant or breastfeeding.

- Subject has received prior treatment with mongersen (GED-0301), or participation in a
clinical study involving mongersen (GED-0301).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: GED-0301

Primary Outcome(s)

Change from baseline of Smad7 (Mothers Against Decapentaplegic homolog 7) expression in the intestinal mucosa [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

The proportion of subjects achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score < 150, at Weeks 4, 8, and 12 [Time Frame: Up to week 12]

Change from baseline in messenger ribonucleic acid (mRNA) expression of inflammatory cytokines [Time Frame: Baseline and Week 12]

Number of Adverse Events [Time Frame: Up to Week 56]

Change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 and 52 [Time Frame: Week 12 and week 52]

Secondary ID(s)

GED-0301-CD-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors