Phase
Condition
Inflammatory Bowel Disease
Colic
Crohn's Disease
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has a diagnosis of Crohn's disease (CD) established at least 3 months prior toScreening by clinical and endoscopic evidence corroborated by a histopathology report.Cases of CD established at least 6 months prior to randomization for which ahistopathology report is not available will be considered based on the weight ofevidence supporting the diagnosis and excluding other potential diagnosis, and must bediscussed with the sponsor on a case-by-case basis prior to randomization.
- Has moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1of the following:
- C-reactive protein (CRP) level >2.87 mg/L during the Screening Phase, OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomoticulcerations (each >0.5 cm in diameter) or 10 aphtous ulcerations (involving aminimum of 10 contiguous cm of intestine) consistent with CD, within 4 monthsprior to randomization, OR
- Fecal calprotectin >250 μg/g stool during the Screening Phase in conjunction withcomputed tomography enterography (CTE), magnetic resonance enterography (MRE),contrast enhanced small bowel radiography, or wireless capsule endoscopyrevealing CD ulcerations (aphthae not sufficient), within 4 months prior toScreening
- Has CD involvement of the ileum and/or colon, at a minimum.
- Has extensive colitis or pancolitis of >8 years duration or limited colitis of >12years duration must have documented evidence that a surveillance colonoscopy wasperformed within 12 months prior to initial screening (may be performed duringScreening if not performed in previous 12 months).
- Has a family history of colorectal cancer, personal history of increased colorectalcancer risk, age >50 years, or other known risk factor must be up-to-date oncolorectal cancer surveillance (may be performed during Screening).
- Has demonstrated an inadequate response to, loss of response to, or intolerance of atleast 1 of the following agents as defined below:
- Corticosteroids.
- Immunomodulators.
- Tumor necrosis factor-alpha (TNF-α) antagonists.
Exclusion
Exclusion Criteria:
- Has evidence of abdominal abscess at the initial Screening Visit.
- Has had extensive colonic resection, subtotal or total colectomy.
- Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
- Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, orevidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
- Has had previous exposure to approved or investigational anti-integrins (e.g.,natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, orrituximab.
- Has used topical (rectal) treatment with 5-ASA, corticosteroid enemas/suppositories ortraditional Chinese medications for CD treatment within 2 weeks of the administrationof the first dose of study drug.
- Requires currently or is anticipated to require surgical intervention for CD duringthe study.
- Has a history or evidence of adenomatous colonic polyps that have not been removed.
- Has a history or evidence of colonic mucosal dysplasia including low or high-gradedysplasia, as well as indeterminate for dysplasia.
- Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,ischemic colitis, and radiation colitis.
- Has evidence of treatment for C.difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
- Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)infection.
- Has active or latent tuberculosis.
- Has any identified congenital or acquired immunodeficiency (e.g., common variableimmunodeficiency, human immunodeficiency virus [HIV] infection, organtransplantation).
- Has any history of malignancy, except for the following: (a) adequately-treatednonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has beenadequately treated and that has not recurred for at least 1 year prior torandomization; and (c) history of cervical carcinoma in situ that has been adequatelytreated and that has not recurred for at least 3 years prior to randomization.Participants with remote history of malignancy (e.g., >10 years since completion ofcurative therapy without recurrence) will be considered based on the nature of themalignancy and the therapy received and must be discussed with the sponsor on acase-by-case basis prior to randomization.
- Has a history of any major neurological disorders, including stroke, multiplesclerosis, brain tumor, or neurodegenerative disease.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptomchecklist at Screening or prior to the administration of the first dose of study drugat Week 0.
Study Design
Study Description
Connect with a study center
Gastroenterology
Hefei, Anhui 230024
ChinaSite Not Available
Gastroenterology
Beijing, Beijing 100050
ChinaSite Not Available
Gastroenterology
Chongqing, Chongqing 400037
ChinaSite Not Available
Gastroenterology
Fuzhou, Fujian 350025
ChinaSite Not Available
Gastroenterology
Xiamen, Fujian 361004
ChinaSite Not Available
Gastroenterology
Guangzhou, Guangdong 510080
ChinaSite Not Available
Gastroenterology
Wuhan, Hubei 430060
ChinaSite Not Available
Gastroenterology
Changsha, Hunan 410013
ChinaSite Not Available
Gastroenterology
Nanjing, Jiangsu 210008
ChinaSite Not Available
Gastroenterology
Wuxi, Jiangsu 241023
ChinaSite Not Available
Gastroenterology
Nanchang, Jiangxi 330006
ChinaSite Not Available
Gastroenterology
Changchun, Jilin 130000
ChinaSite Not Available
Gastroenterology
Shenyang, Liaoning 110022
ChinaSite Not Available
Gastroenterology
Shanghai, Shanghai 200092
ChinaSite Not Available
Gastroenterology
Chengdu, Sichuan 610041
ChinaSite Not Available
Gastroenterology
Tianjin, Tianjin 300052
ChinaSite Not Available
Gastroenterology
Kunming, Yunnan 650032
ChinaSite Not Available
Gastroenterology
Hangzhou, Zhejiang 310009
ChinaSite Not Available

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