Crohn Disease

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned.

Mongersen (GED-0301)

Mongersen (GED-0301)

Gastro-resistant, delayed release, pH-dependent tablet

40mg/tablet, 160mg/tablet

Primary Outcome Measures:
1. Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and Crohn's Disease Activity Index (CDAI) (Rest of World).

Secondary Outcome Measures:
1. Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI.
2. Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD).
3. Clinical response defined by CDAI.
4. Clinical remission defined by PCDAI.
5. Adverse Events (AEs).
6. Pharmacokinetics (PK)- plasma concentration of GED-0301.

-篩選回診前已診斷患有CD至少3個月
- 篩選時依據迴腸結腸鏡檢查確認表現出迴腸炎、迴腸結腸炎或結腸炎
- 篩選時患有活動性疾病，定義為克隆氏症活性指數 (CDAI) 分數≥ 220且≤ 450
-篩選時的7天平均液狀便或軟便頻率≥ 3.5次，或腹痛≥ 1.5次
-篩選時SES-CD總分≥ 6，或者篩選時迴腸段SES-CD ≥ 4分
-必須曾以至少一種下列藥物治療失敗或耐受不佳： budesonide；全身性皮質類固醇；免疫抑制劑（即：AZA、6-MP或MTX）；或治療CD之生物製劑（即：infliximab、adalimumab、certolizumab或vedolizumab）

1. The presence of any of the following will exclude a subject from enrollment: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency
2. Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
3. Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
4. Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
5. Ileostomy or a colostomy
6. Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
7. Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.