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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641392
Recruitment Status : Terminated (Study terminated by Sponsor following a recommendation from external DMC based on lack of emerging benefit; there were no new emergent safety findings)
First Posted : December 29, 2015
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

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.

The GED-0301-CD-003 trial was not initiated; see detailed description.


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: GED-0301 Other: Placebo Phase 3

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 placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : January 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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

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 placebo and GED-0301 40 mg
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




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 [ Time Frame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose ]
    A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641392


  Show 231 Study Locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Guillermo Rossiter, MD Celgene
  Study Documents (Full-Text)

Documents provided by Celgene:
Study Protocol  [PDF] January 6, 2017
Statistical Analysis Plan  [PDF] April 12, 2018


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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02641392     History of Changes
Other Study ID Numbers: GED-0301-CD-004
First Posted: December 29, 2015    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019
Last Verified: January 2019

Keywords provided by Celgene:
Crohn's Disease
GED 0301
Mongersen
Safety
Irritable Bowel Disease

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