SAR441566 for Crohn's Disease

(SPECIFI-CD Trial)

Recruiting at 171 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

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

Disqualifiers: Active UC, Active TB, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the effectiveness of different doses of the experimental drug SAR441566 for individuals with moderate to severe Crohn's Disease. Crohn's Disease causes inflammation in the digestive tract, leading to symptoms like frequent diarrhea and stomach pain. The study seeks to determine if SAR441566 can improve these symptoms compared to a placebo (a non-active treatment). Individuals who have had Crohn's Disease for at least three months and have not responded well to other treatments may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that SAR441566 is likely to be safe for humans?

Earlier research tested SAR441566 to assess its safety for people. Although detailed safety information from these studies is unavailable, its progression to a phase 2 trial indicates it passed initial safety tests in earlier stages. In these stages, researchers typically test a small group to determine safety and optimal dosage. Thus, being in phase 2 suggests SAR441566 has shown some promise regarding safety. However, phase 2 trials continue to monitor side effects and participants' tolerance of the drug. Study participants will be closely monitored for any unwanted effects, ensuring quick response to any safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for Crohn's Disease?

SAR441566 is unique because it offers a novel approach to treating Crohn's Disease by using a new active ingredient that hasn't been used in standard treatments. While most current treatments, like biologics and immunosuppressants, focus on dampening the immune response generally, SAR441566 targets specific pathways involved in inflammation more directly. This targeted mechanism could potentially lead to fewer side effects and improved efficacy, which is why researchers are excited about its potential.

What evidence suggests that SAR441566 could be an effective treatment for Crohn's Disease?

Studies have shown that SAR441566 may help reduce inflammation in people with Crohn's Disease (CD). This treatment targets specific parts of the immune system that cause gut inflammation. Earlier research on similar drugs has led some patients to experience significant symptom improvement, known as clinical remission. The trial aims to use SAR441566 to better manage symptoms and reduce flare-ups. While research continues, early findings suggest that SAR441566 could be a promising option for those with moderate to severe CD. Participants in this trial will receive different doses of SAR441566 or a placebo to evaluate its effectiveness and safety. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 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.

I tried standard cancer treatments but they didn't work or caused side effects.

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

Screening laboratory and other analyses show abnormal results

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SAR441566

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

The study developed a mouse model (NSG-CD) using immune cells from Crohn's disease patients, which exhibited key features of human Crohn's disease, including increased collagen deposition and specific immune cell profiles.

This model allows researchers to better understand the mechanisms of intestinal fibrosis in Crohn's disease, potentially leading to improved therapeutic strategies that reflect human disease conditions.

NCBI (Pubmed)

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. Unterweger, AL., Rüscher, A., Seuß, M., et al.[2021]

In a Phase I-2 trial involving 22 children aged 6-16 with moderate to severe Crohn's disease, sargramostim (SRG) was found to be safe and well tolerated at doses of 4 and 6 microg/kg, with mild injection-site reactions occurring in 90% of patients.

The study showed promising efficacy results, with 88% of patients achieving remission or a positive response, indicating that sargramostim may be an effective therapy for improving granulocyte function in Crohn's disease, although further trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of sargramostim in pediatric Crohn's disease. Kelsen, JR., Rosh, J., Heyman, M., et al.[2018]

In a study involving 11 Japanese patients with moderately to severely active Crohn's disease, sargramostim showed a dose-dependent increase in systemic exposure, with a notable decrease in median Crohn's Disease Activity Index (CDAI) scores after treatment.

Despite some improvement in CDAI scores, only a minority of patients achieved clinical remission or response, indicating that while sargramostim may have some efficacy, its overall effectiveness in this population appears limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sargramostim in patients with Crohn's disease: results of a phase 1-2 study. Takazoe, M., Matsui, T., Motoya, S., et al.[2021]

In patients with Crohn's disease (CD), there is a significant increase in the expression of co-stimulatory molecules CD86 and ICOS in the intestinal mucosa compared to normal controls, indicating their potential role in the disease's pathogenesis.

The study found that CD4 and CD8 positive lymphocytes were also significantly elevated in the intestinal tissue of CD patients, suggesting an active immune response that may contribute to the inflammation seen in Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Expression of co-stimulatory molecule CD86 and its inducible co-stimulator in Crohn disease and their pathologic significance]. Chen, AJ., Li, F., DU, J., et al.[2017]

Crohn's disease is linked to genetic susceptibility and environmental triggers that disrupt both innate and adaptive immune responses, leading to inflammation and a reduced diversity of gut microbiota.

The paper outlines new diagnostic and management strategies for Crohn's disease, including advanced imaging techniques and emerging therapeutic targets like integrins and stem-cell therapies, aimed at improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crohn's disease. Baumgart, DC., Sandborn, WJ.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06637631

NCT06637631 | A Study to Investigate Efficacy and Safety ... A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/547722

A Study to Investigate Efficacy and Safety of SAR441566 in ... Outcome measure. Proportion of participants achieving both clinical remission and endoscopic response · Measure description. Clinical remission and endoscopic ...

3. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=23538&isClinicalTrial=True

ANZCTR - Registration A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. ... inflammatory bowel disease. It consists of 32 ...

4. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312984/crohns-disease-for-sar441566/

Crohn's Disease for SAR441566 The purpose of this study is to compare the effectiveness of different doses of the investigational medication to a placebo, which is an inactive substance that ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660281/

Advancing therapeutic frontiers: a pipeline of novel drugs for ... Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that affects millions of people worldwide. Many people with CD do not respond ...

6. sanofi.com sanofi.com/en/clinical-trials/nct06637631

A Study to Investigate Efficacy and Safety of SAR441566 in ... This study investigates an investigational medication for adults with moderate to severe Crohn's Disease, a condition that causes inflammation in the ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=1803ffee-a3ed-45e0-8bcd-571ba5fa8577

balinatunfib (SAR441566) / Sanofi SPECIFI-CD: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (clinicaltrials.gov) - P2 | N=260 | Recruiting ...