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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 July 2017 by Celgene
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02641392
First received: December 23, 2015
Last updated: July 25, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:

Primary Outcome Measures:
  • Adverse Events (AEs) - Adult Subjects [ Time Frame: Approximately up to Week 212 ]
    The evaluation of safety of GED-0301, 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 electrocardiograms (ECGs), vital signs, and/or laboratory findings

  • Adverse Events (AEs) - Adolescent Subjects [ Time Frame: Approximately up to Week 212 ]
    The evaluation of safety of GED-0301, 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 electrocardiograms (ECGs), vital signs, and/or laboratory findings


Secondary Outcome Measures:
  • To evaluate the efficacy of GED-0301 on clinical activity in subjects with CD in adolescent subjects [ Time Frame: Up to week 40 ]
    The proportion of subjects with clinical remission at Week 40.

  • To evaluate long-term endoscopic outcomes of GED-0301 in subjects with CD in adolescent subjects [ Time Frame: Up to week 40 ]
    The proportion of subjects with endoscopic remission defined as SES-CD ≤ 2 at Week 40

  • To evaluate the long-term changes in linear growth in response to GED-0301 in subjects with CD in adolescent subjects [ Time Frame: Up to week 40 ]
    The change from baseline in weight, height, body mass index (BMI), and height velocity z-scores (adjusted for chronological age) at Week 40


Estimated Enrollment: 1300
Actual Study Start Date: July 25, 2016
Estimated Study Completion Date: October 28, 2022
Estimated Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GED-0301 (160 mg) followed by Placebo 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 208 weeks, if the subject previously received Placebo in the prior GED-0301 Study
Drug: GED-0301
Mongersen
Other Name: Mongersen
Other: Placebo
Placebo
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
Mongersen
Other Name: Mongersen
Other: Placebo
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
Mongersen
Other Name: Mongersen
Other: Placebo
Placebo
Experimental: Continuous GED-0301 40 mg
GED-0301 40 mg once daily (QD) for up to 208 weeks
Drug: GED-0301
Mongersen
Other Name: Mongersen
Experimental: Intermittent placebo and GED-0301 160 mg
Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208
Drug: GED-0301
Mongersen
Other Name: Mongersen
Other: Placebo
Placebo

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. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

  1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
  2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
  3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
  4. continuous GED-0301 40 mg once daily through Week 208;
  5. alternating GED-0301 40 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Adult Subjects:

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.

Inclusion Criteria for Adolescent Subjects:

Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study

  • Male or female 12 to 17 years of age.
  • Subject must have participated in the GED 0301 CD 003 study.
  • Subject is able to swallow the IP tablets.
  • Subject must use protocol approved contraception.

Exclusion Criteria for Adult and Adolescent Subjects:

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 440 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Guillermo Rossiter, MD Celgene
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02641392     History of Changes
Other Study ID Numbers: GED-0301-CD-004
Study First Received: December 23, 2015
Last Updated: July 25, 2017

Keywords provided by Celgene:
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 August 21, 2017