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Mongersen Long-term Extension in Crohn's Disease
NCT02641392Phase 3
Key facts
- Status
- Terminated
- Start
- Jul 2016
- Primary completion
- Jan 2018
- Countries
- 31
- Sponsor
- Celgene Corporation
- Modality
- Modified DNA Oligonucleotides, Single-strand DNA, Antisense Oligonucleotides (ASOs)
- Drugs
- mongersen
- Conditions
- Crohn's disease
01
Overview
Phase 3, double-blind trial of mongersen in Crohn's disease (5 arms), sponsored by Celgene Corporation. Primary endpoint: Treatment Emergent Adverse Events. Started Jul 2016; status: terminated.
02
Design
5 arms- Study design
- Non-randomizedDouble-blind
GED-0301 160 mg -> Intermittent
Continuous GED-0301 160 mg for 12 weeks, then alternating Placebo/GED-0301 160 mg.
Intermittent GED-0301 160 mg
Alternating GED-0301 160 mg and Placebo.
Intermittent Placebo/GED-0301 40 mg
Alternating Placebo and GED-0301 40 mg.
Continuous GED-0301 40 mg
Continuous GED-0301 40 mg.
Intermittent Placebo/GED-0301 160 mg
Alternating Placebo and GED-0301 160 mg.
03
Who it enrols
Adults and adolescents who participated in prior Phase 3 GED-0301 studies (GED-0301-CD-002 or GED-0301-CD-003).
04
Endpoints
Primary
Treatment Emergent Adverse Events
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