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Trial record 43 of 2041 for:    digestive | Open Studies | Exclude Unknown | United States

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02641392
First received: December 23, 2015
Last updated: September 12, 2016
Last verified: September 2016
  Purpose

This is a Phase 3, double-blind, active treatment extension study to evaluate the long-term safety of GED-0301 over 208 weeks in subjects with Crohn's disease (CD) who previously participated in either of the following two Phase 3 GED-0301 studies:

  • Study GED-0301-CD-002
  • Study GED-0301-CD-003

Condition Intervention Phase
Crohn's Disease
Drug: GED-0301
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Mongersen GED-0301 Maintenance Therapy in Subjects With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Adverse Events (AEs) [ Time Frame: Up to approximately 208 weeks ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse events


Estimated Enrollment: 1400
Study Start Date: July 2016
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GED-0301 Induction (160 mg) followed by intermittent 160 mg
GED-0301 160 mg once daily (QD) for 12 weeks, followed by alternating Placebo (PBO) QD for 4 weeks with GED 0301 160 mg QD for 4 weeks, up to 196 weeks, if the subject previously received Placebo in the prior GED-0301 Study
Drug: GED-0301
Other Name: Mongersen
Experimental: Intermittent GED-0301 160 mg and placebo
Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study
Drug: GED-0301
Other Name: Mongersen
Other: Placebo
Experimental: Intermittent GED-0301 40 mg and placebo
Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study
Drug: GED-0301
Other Name: Mongersen
Other: Placebo
Experimental: Continuous GED-0301 40 mg
GED-0301 40 mg once daily (QD) for up to 208 weeks
Drug: GED-0301
Other Name: Mongersen

Detailed Description:

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. The duration of the treatment is up to 208 weeks and will consist of 3 periods:

  • Screening Period - up to 4 weeks
  • Long-term Active Treatment Period - 208 Weeks (Week 0 to Week 208)
  • Follow-up Period - 4 weeks (ie, no Investigational product (IP) taken) The primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be screened and enrolled in the study:

  • Male or female ≥ 18 years of age.
  • Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.
  • Subject must use protocol approved contraception.

Exclusion Criteria:

The presence of any of the following will exclude a subject from screening and enrollment:

  • Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.
  • Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
  • Subject is pregnant or breastfeeding.
  • Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02641392

Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 334 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Keith Usiskin, MD Celgene
  More Information

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02641392     History of Changes
Other Study ID Numbers: GED-0301-CD-004 
Study First Received: December 23, 2015
Last Updated: September 12, 2016
Health Authority: Canada: Health Canada

Keywords provided by Celgene Corporation:
Crohn's Disease
GED 0301
Mongersen
Safety
IBD

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 28, 2016