Clinical trial
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
Name
CL003_282
Description
The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on the some of the symptoms of Crohn's Disease in patients who are experiencing an active flare-up of moderate to severe Crohn's Disease.
Trial arms
Trial start
2004-08-01
Trial end
2005-12-01
Status
Completed
Phase
Early phase I
Treatment
CCX282-B
Size
70
Primary endpoint
Crohn's Disease Activity Index score
Safety (Adverse Events, tolerability)
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 70}}
Updated at
2023-08-25
1 organization
1 product
1 indication
Organization
ChemoCentryxProduct
CCX282-BIndication
Crohn's Disease