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

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329537

Enrollment

Registered

2006-05-24

Start date

2006-06-30

Completion date

2007-05-31

Last updated

2013-12-04

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, Sargramostim, CDAI, Moderately to severely active Crohn's Disease

Brief 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.

Detailed 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.

Interventions

DRUGSargramostim (Leukine)

Self-subcutaneous injection

DRUGPlacebo

Self-subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CDAI [Crohn's Disease Active Index] improvements	Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w

Secondary

Measure	Time frame
PRO [Patient-reported outcome] variables (QOL [Quality of life]	Baseline, 1w, 4w, 8w, 12w
PGI-C [Patient global impression of change])	Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w

Outcome results

None listed

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