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)
Sponsor: Genzyme, a Sanofi Company
Terminated
This trial was terminated. No reason was provided.
Other terminated trials from Genzyme, a Sanofi Company
Listed as NCT00329537, this PHASE2 trial focuses on Crohn's Disease and remains terminated or withdrawn. Sponsored by Genzyme, a Sanofi Company, it has been updated 6 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Terminated PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Terminated PHASE2
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE2
First recorded
Jun 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Genzyme, a Sanofi Company
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.