台灣臨床試驗主持人資料庫|TPIDB

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberGED-0301-CD-004

NCT Number(ClinicalTrials.gov Identfier)NCT02641392

2017-09-06 - 2021-05-31

Phase III

Terminated6

ICD-10K50.90

Crohn's disease, unspecified, without complications

ICD-10K50

Crohn's disease [regional enteritis]

ICD-9555.9

Regional enteritis, unspecified site

A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Trial Applicant

IQVIA RDS Taiwan Ltd.
Sponsor

Celgene Corporation
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Jen-Wei Chou Digestive System Department

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 許自齊 Division of Colorectal Surgery

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Yao Su Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jen-Wei Chou 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

CRO

Principal Investigator Chiao-Hsiung Chuang Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 許自齊 Division of Colorectal Surgery

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Crohn's Disease

Objectives

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.

Test Drug

Mongersen (GED-0301)

Active Ingredient

Mongersen (GED-0301)

Dosage Form

Gastro-resistant, delayed release, pH-dependent tablet

Dosage

40 mg/tablet

Endpoints

Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208.

Inclution Criteria

1. Inclusion Criteria for Adult Subjects:
Subjects must satisfy the following criteria to be screened and enrolled in the study:
(1) Male or female ≥ 18 years of age.
(2) Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.
(3) Subject must use protocol approved contraception.

2. Inclusion Criteria for Adolescent Subjects:
Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study
(1) Male or female 12 to 17 years of age.
(2) Subject must have participated in the GED 0301 CD 003 study.
(3) Subject is able to swallow the IP tablets.
(4) Subject must use protocol approved contraception.

Exclusion Criteria

The presence of any of the following will exclude a subject from screening and enrollment:
1. Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.
2. Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
3. Subject is pregnant or breastfeeding.
4. Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.

The Estimated Number of Participants

Taiwan

15 participants
Global

1500 participants