Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

NCT00739986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-11-09

No results posted yet for this study

Summary

Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).

Conditions

Interventions

DRUG

Semapimod

semapimod 60 mg IV x 1 day, placebo x 2 days

DRUG

Semapimod

Semapimod 60 mg IV x 3 days

DRUG

Placebo

placebo IV x 3 days

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daan Hommes, MD · Academic Medical Center, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2004-06-30
Completion
2004-08-31

Countries

  • United States
  • Belgium
  • Germany
  • Israel
  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00739986 on ClinicalTrials.gov