NCT02367183 is a Phase 1 clinical trial of GED-0301 in Crohn Disease, sponsored by Celgene.

Who is sponsoring NCT02367183?

NCT02367183 is sponsored by Celgene.

What drugs are being tested in NCT02367183?

Interventions in NCT02367183: GED-0301, Placebo.

What condition does NCT02367183 study?

NCT02367183 studies Crohn Disease.

Is NCT02367183 still recruiting?

NCT02367183 is currently completed. Last updated 10 January 2019.

Last reviewed 2019-01-10 · How we verify

NCT02367183

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease

Completed Phase 1 Last updated 10 January 2019

What this trial tests

Phase 1 trial testing GED-0301 in Crohn Disease in 64 participants. Completed in 14 December 2017.

Timeline

8 April 2015

Primary endpoint
6 September 2016

14 December 2017

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	8 April 2015
Primary completion	6 September 2016
Estimated completion	14 December 2017
Sites	50 locations across Slovakia, Hungary, Canada, Australia, United States

Drugs / interventions tested

GED-0301 — full drug profile →
Placebo

Conditions studied

Crohn Disease — all drugs for Crohn Disease →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn's Disease.
Feagan BG, Sands BE, Rossiter G, Li X, et al · · 2018 · cited 54× · PMID 28847751 · DOI 10.1053/j.gastro.2017.08.035
P515 A 12-week tailored physical training program including dietary advice in children with Inflammatory Bowel Disease: a randomized crossover trial
Scheffers L, van den Berg L, Pijnenburg M, Utens E, et al · · 2021

Verify or expand the search:

Other trials of GED-0301

Trials testing the same drug.

NCT02974322 — A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Cr · Phase 3 · withdrawn
NCT02641392 — A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease · Phase 3 · terminated
NCT02685683 — Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease · Phase 2 · terminated
NCT02601300 — An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis · Phase 2 · completed
NCT02596893 — Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease · Phase 3 · terminated

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02367183 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 10 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02367183.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing