Study Evaluating ERB-041 in Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245947

Enrollment

Registered

2005-10-28

Start date

2004-04-30

Completion date

2005-04-30

Last updated

2009-09-10

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

Conditions

Crohn's Disease

Keywords

Crohn's Disease, Inflammation

Brief summary

Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.

Interventions

DRUGERB-041

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months, * Eligible subjects must have adequate hematologic, renal, and hepatic function. Other inclusions apply

Exclusion criteria

* Use of the following medications within the specified time period before randomization is prohibited: Within 48 hours before randomization * Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization * Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components). Other exclusions applies

Design outcomes

Primary

Measure	Time frame
Inflammatory serum markers	—
Pharmacogenomics	—
Safety	—

Secondary

Measure	Time frame
Crohn's Disease Activity Index (CDAI) scores.	—
Cell surface markers	—
Fecal markers	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026