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Sargramostim

Phase 3

Crohn Disease | Small molecule | Gastrointestinal |Sanofi|Last Updated: Dec 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment413

FDA Designations

No designations recorded

Clinical trial landscape

Sargramostim · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00206674Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseaseCrohn Disease
COMPLETED286 Analytics
PHASE3COMPLETED
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Crohn DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Induction of clinical response and/or remission as defined by decrease in CDAI score
After 8 weeks of treatment
Corticosteroid-free remission
At the end of the study treatment

Secondary Endpoints

Time and duration to response/remission
During the 8 weeks of treatment
QoL (different methods)
During the whole study
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
About 20 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Sargramostim (Leukine)DRUG6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
PlaceboDRUGSterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites70

Inclusion Criteria: * Stable but active Crohn's disease at the time of screening * Must be able to self-inject or have another person who can help with the injection Exclusion Criteria: * Not have a colostomy or ileostomy * Not be taking prohibited medications as defined in the protocol * Not hav...

Countries:ArgentinaAustraliaBrazilCanadaNew ZealandRussiaSwitzerlandUkraineUnited Kingdom
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Frequently asked questions about Sargramostim

What is Sargramostim used for in Crohn Disease?

Sargramostim is an investigational small molecule being studied for the treatment of Crohn Disease. It is being developed by Sanofi (SNY) and has completed clinical trials in patients with moderate to severe Crohn's disease, as well as in steroid-dependent patients. The drug is not approved and remains in clinical development.

How does Sargramostim work?

Sargramostim is a small molecule being investigated for Crohn Disease. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here. The drug is being evaluated for its ability to induce response and remission in patients with moderate to severe Crohn's disease.

Who makes Sargramostim?

Sargramostim is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials of Sargramostim in patients with Crohn Disease, including a Phase 3 study in moderate to severe disease and a Phase 2 study in steroid-dependent patients.

What phase is Sargramostim in?

Sargramostim is in Phase 3 clinical development for Crohn Disease. A Phase 3 trial, NCT00206674, has been completed, along with a Phase 2 trial, NCT00206596. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Sargramostim in?

Sargramostim has been studied in two completed clinical trials for Crohn Disease. NCT00206674 was a Phase 3 study in 286 patients with moderate to severe Crohn's disease, conducted across multiple countries. NCT00206596 was a Phase 2 study in 127 steroid-dependent patients. Both trials were randomized, double-blind, and placebo-controlled.

Is Sargramostim the same as other drugs?

Sargramostim is not known to have alternative names in the available information. It is being studied specifically for Crohn Disease by Sanofi. No other names for this drug have been reported in clinical trial records.