Crohn's Disease Clinical Trial
Official title:
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
| Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
| Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
| Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
| Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
| Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
| Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
| Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
| Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
| Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
| Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
| Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
| Completed |
NCT01958827 -
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
|
Phase 3 |