A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Amgen

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: CCX282-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306215

CL004_282

Details and patient eligibility

About

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Full description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• moderate to severe Crohn's Disease
• CDAI 250-450
• CRP >7.5
• signed written informed consent

Key Exclusion Criteria:

• > 100 cm of small bowel resected
• ileostomy, colostomy or rectal pouch
• diagnosis of ulcerative colitis or indeterminate colitis
• evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
• hepatitis B, C or HIV infection
• history of infection requiring IV antibiotics
• serious or GI infection in the previous 12 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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436 participants in 4 patient groups

1

Experimental group

Description:

Blinded study arm

Treatment:

Drug: CCX282-B

2

Experimental group

Description:

Blinded study arm

Treatment:

Drug: CCX282-B

3

Experimental group

Description:

Blinded study arm

Treatment:

Drug: CCX282-B

4

Experimental group

Description:

Blinded study arm

Treatment:

Drug: CCX282-B