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

Celgene

Status and phase

Terminated

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: GED-0301

Study type

Interventional

Funder types

Industry

Identifiers

NCT02685683

GED-0301-CD-005

Details and patient eligibility

About

This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease

Full description

Subjects will be screened to provide 20 enrolled subjects who complete 12 weeks of mongersen (GED-0301) 160 mg QD treatment as open-label therapy.

The study will consist of 4 periods:

Screening Period - up to 4 weeks Induction Period - 12 weeks (Week 0 Visit through Week 12 Visit) Maintenance Period - 88 weeks (after Week 12 Visit through Week 100 Visit) Follow-up Period - 4 weeks (ie, no IP taken)

Subjects who prematurely discontinue treatment from this study prior to Week 100 will have an Early Termination Visit and also enter the 4-week Follow-up Period.

At the Screening Visit, all subjects who meet the entrance criteria will be eligible to enter the study. The number of subjects with previous exposure to Tumor Necrosis Factor-Alpha (TNF-α) blockers is targeted to be approximately 40% (ie, approximately 8 subjects).

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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-α 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).