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

A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00306215

Enrollment

436

Registered

2006-03-23

Start date

2006-03-31

Completion date

2009-06-30

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

double-blind, placebo-controlled, multicenter, efficacy, safety

Brief summary

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

Detailed description

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

Interventions

DRUGCCX282-B

CCX282-B or placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57	Day 57

Secondary

Measure	Time frame
Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57	Day 57

Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Netherlands, Poland, South Africa, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026