Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 March 2025
• Main ID: NCT00102921
• Date of registration: 04/02/2005
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
• Scientific title: Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn's Disease
• Date of first enrolment: August 2004
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00102921
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be
active at the time of study entry

- Use of adequate and approved methods of birth control throughout the study period

- Willing and able to sign an informed consent

Exclusion Criteria:

- Pregnant or breastfeeding

- Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; the
virus that causes AIDS)

- Abuse of alcohol or of illegal drugs


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: CCX282-B

Primary Outcome(s)

Safety (Adverse Events, tolerability)

Crohn's Disease Activity Index score

Secondary Outcome(s)

C-reactive protein

Endoscopic appearance and biopsy of colon and terminal ileum

Inflammatory Bowel Disease Questionnaire

Markers of leukocyte subsets and activation status

Secondary ID(s)

CL003_282

Source(s) of Monetary Support

Please refer to primary and secondary sponsors