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)
2 other identifiers
interventional
11
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2006
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedDecember 4, 2013
December 1, 2013
11 months
May 23, 2006
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CDAI [Crohn's Disease Active Index] improvements
Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w
Secondary Outcomes (2)
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
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 24, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
December 4, 2013
Record last verified: 2013-12