Study Evaluating rhIL-11 in Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00040521

Enrollment

Unknown

Registered

2002-06-28

Start date

2002-04-30

Completion date

2003-10-31

Last updated

2013-02-08

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

Conditions

Crohn Disease, Inflammatory Bowel Disease

Keywords

Crohn's Disease, Active Crohns Disease

Brief summary

The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index \[CDAI\] score from 220-400).

Interventions

DRUGRecombinant Human Interleukin-11 (rhIL-11)

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed. * Men and women age 16 years and over. * Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)

Exclusion criteria

Use of the following medications within the specified time period prior to randomization: * Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 \[COX-2\] inhibitors and \>500 mg/day acetylsalicylic acid) * Codeine-containing compounds * Corticosteroid enemas

Countries

United States

Outcome results

None listed

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