Study of Sargramostim in Moderately to Severely Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00329537
• Other study ID #: 309240
• Secondary ID: 91510
• Status: Terminated
• Phase: Phase 2
• First received: May 23, 2006
• Last updated: December 2, 2013
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.

Description:

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug

• Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index [CDAI] >220 and <475 points)

Exclusion Criteria:

• Colostomy or ileostomy

• Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage

• GI surgery within 6 months prior to receiving the 1st dose of study drug

• Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Sargramostim (Leukine)
Self-subcutaneous injection
• Placebo
Self-subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDAI [Crohn's Disease Active Index] improvements		Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w
Secondary	PRO [Patient-reported outcome] variables (QOL [Quality of life]		Baseline, 1w, 4w, 8w, 12w
Secondary	PGI-C [Patient global impression of change])		Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w

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