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Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00038922
Enrollment
Unknown
Registered
2002-06-07
Start date
Unknown
Completion date
Unknown
Last updated
2006-05-18

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

Conditions

Inflammatory Bowel Disease, Ulcerative Colitis

Keywords

Left-Sided, Ulcerative, Colitis

Brief summary

To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.

Interventions

DRUGrhIL-11

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Documented, signed informed consent to participate in this study * Age greater than or equal to 18 years * Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy

Exclusion criteria

* Crohn's disease * Ulcerative proctitis * Ulcerative colitis extending beyond the splenic flexure

Outcome results

None listed

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