SAR441566 for Crohn's Disease

(SPECIFI-CD Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Must not be taking: Cyclosporine, Tacrolimus, Mycophenolate, Thalidomide

Disqualifiers: Active UC, Active TB, HIV, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks. The MS period include a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. At the end of 52 weeks in the MS period, eligible participants from MS period will be offered a Double-Blind Maintenance Extension (DBME) period for up to 52 weeks. Additionally, an Open Label (OL) period of up to 92 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks, while the sum of the DBME and OL periods may not exceed 52 weeks, depending on when participants switch.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be on stable doses of standard treatments before screening. Some medications like cyclosporine, tacrolimus, and certain others must not have been taken within 30 days before screening.

How is the drug SAR441566 different from other treatments for Crohn's disease?

SAR441566, also known as sargramostim, is unique because it aims to improve granulocyte function, which may help manage Crohn's disease by enhancing the body's immune response. This approach differs from other treatments that primarily focus on suppressing the immune system.

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Eligibility Criteria

Adults aged 18-75 with moderate to severe Crohn's Disease, diagnosed for at least 3 months. Participants must have tried standard treatments or advanced therapies without success or could not tolerate them. They should be on stable medication doses before the trial and use approved contraception methods.

Inclusion Criteria

I am between 18 and 75 years old.

I have been diagnosed with Crohn's disease for at least 3 months.

I am not pregnant or breastfeeding and will use approved birth control during the study.

Exclusion Criteria

I haven't taken cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide in the last 30 days.

Participants with stool sample positive for infectious pathogens

I have active ulcerative colitis, indeterminate colitis, or short bowel syndrome.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Double-Blind Induction Treatment

Participants receive SAR441566 or placebo for induction treatment

12 weeks

Regular visits (in-person)

Double-Blind Maintenance Treatment

Participants continue receiving SAR441566 or placebo for maintenance treatment

40 weeks

Regular visits (in-person)

Double-Blind Maintenance Extension

Eligible participants continue maintenance treatment

Up to 52 weeks

Open Label Extension

Participants may opt into continuation of treatment in an open-label format

Up to 92 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests SAR441566's effectiveness and safety in different doses compared to a placebo in patients with Crohn's Disease over a period of up to 144 weeks, including phases of double-blind treatment and an open-label extension for eligible participants.

Group I: SAR441566 dose 3 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose 3.

Group II: SAR441566 dose 2 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose 2.

Group III: SAR441566 dose 1 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose 1.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive SAR441566 matching placebo.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Frontier Clinical Research, LLC- Site Number : 8400009 Uniontown, PA

Washington Gastroenterology - Tacoma- Site Number : 8400008 Tacoma, WA

Clinical Research of Osceola- Site Number : 8400013 Kissimmee, FL

GI Alliance - Glenview- Site Number : 8400015 Glenview, IL

More Trial Locations

Who Is Running the Clinical Trial?

Sanofi Lead Sponsor

References

1. Japan pubmed.ncbi.nlm.nih.gov

Sargramostim in patients with Crohn's disease: results of a phase 1-2 study. [2021] We aimed to assess the tolerability, pharmacokinetics, safety, and efficacy of sargramostim in Japanese patients with active Crohn's disease (CD).

2. England pubmed.ncbi.nlm.nih.gov

Crohn's disease. [2022] Crohn's disease is a relapsing systemic inflammatory disease, mainly affecting the gastrointestinal tract with extraintestinal manifestations and associated immune disorders. Genome wide association studies identified susceptibility loci that--triggered by environmental factors--result in a disturbed innate (ie, disturbed intestinal barrier, Paneth cell dysfunction, endoplasmic reticulum stress, defective unfolded protein response and autophagy, impaired recognition of microbes by pattern recognition receptors, such as nucleotide binding domain and Toll like receptors on dendritic cells and macrophages) and adaptive (ie, imbalance of effector and regulatory T cells and cytokines, migration and retention of leukocytes) immune response towards a diminished diversity of commensal microbiota. We discuss the epidemiology, immunobiology, amd natural history of Crohn's disease; describe new treatment goals and risk stratification of patients; and provide an evidence based rational approach to diagnosis (ie, work-up algorithm, new imaging methods [ie, enhanced endoscopy, ultrasound, MRI and CT] and biomarkers), management, evolving therapeutic targets (ie, integrins, chemokine receptors, cell-based and stem-cell-based therapies), prevention, and surveillance.

3. China pubmed.ncbi.nlm.nih.gov

[Expression of co-stimulatory molecule CD86 and its inducible co-stimulator in Crohn disease and their pathologic significance]. [2017] To investigate the expression of co-stimulatory molecule CD86 and inducible co-stimulator(ICOS) in the intestinal mucosa of Crohn disease (CD) and to exlpore its pathologic significance.

4. England pubmed.ncbi.nlm.nih.gov

NOD/scid IL-2Rγnull mice reconstituted with peripheral blood mononuclear cells from patients with Crohn's disease reflect the human pathological phenotype. [2021] Label="INTRODUCTION">Crohn's disease (CD) is characterized by pronounced intestinal fibrosis and severe mucosal damage and conventional animal models are limited to reflect these pathological manifestations. The aim of this study was to examine whether the combination of patient immune-profiling and preclinical studies in a mouse model based on NOD/scid IL-2Rγnull (NSG) reconstituted with peripheral blood mononuclear cells (PBMC) from CD patients has the capacity to harmonize ex vivo human and in vivo animal studies.

5. England pubmed.ncbi.nlm.nih.gov

Phase I trial of sargramostim in pediatric Crohn's disease. [2018] Improving granulocyte function may represent an effective therapy for Crohn's disease (CD). We performed a Phase I-2 trial of sargramostim (SRG) in children with CD.