SAR441566 for Rheumatoid Arthritis

(SPECIFI-RA Trial)

No longer recruiting at 164 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Methotrexate

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Immunologic disorder, Infections, Heart failure, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR441566, an experimental drug, for individuals with moderate-to-severe rheumatoid arthritis (RA) who haven't found relief with methotrexate, a common RA medication. Researchers aim to evaluate the effectiveness of different doses of SAR441566 over 12 weeks compared to a placebo, a substance with no active ingredient. Participants will continue their methotrexate treatment while adding SAR441566 or a placebo. Candidates may be suitable if they have experienced RA symptoms for at least six months and still suffer from frequent joint pain and swelling despite methotrexate use. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

You will need to continue taking methotrexate (MTX) as part of the trial, but the protocol does not specify if you need to stop other medications. It's best to discuss your current medications with the trial team to get specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SAR441566 is being tested for safety and effectiveness in treating rheumatoid arthritis. Since the drug is in Phase 2 of testing, it has already been tried in a smaller group to assess safety, suggesting early results likely indicate general safety for humans. However, detailed information about side effects is not yet available.

SAR441566 is also undergoing tests for other autoimmune diseases, which may help confirm its safety. Prospective trial participants should discuss any concerns with the clinical team to understand what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for rheumatoid arthritis (RA) aim to reduce inflammation and pain through mechanisms like TNF inhibitors or methotrexate. But SAR441566 works differently, targeting specific pathways involved in the immune response that current treatments don't directly address. This novel approach could potentially offer relief to patients who don't respond well to existing therapies. Researchers are excited about SAR441566 because it may provide a new way to manage RA symptoms, with the possibility of improved effectiveness and fewer side effects compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for rheumatoid arthritis?

Research has shown that SAR441566, taken as a pill, can effectively reduce arthritis symptoms, with higher doses leading to better results. In this trial, participants will receive one of several dose regimens of SAR441566 or a placebo. Studies have found that SAR441566 works by blocking TNFR1 signaling, a key process in causing inflammation. This action may help manage rheumatoid arthritis symptoms. Early clinical data suggest that SAR441566 is generally safe and well-tolerated. These promising findings make it a potential new treatment for people with moderate-to-severe rheumatoid arthritis. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults with moderate-to-severe rheumatoid arthritis not well-controlled on methotrexate, who haven't used biologic or targeted synthetic DMARDs. Participants must have had RA symptoms for at least 6 months, be taking a stable dose of methotrexate for 12 weeks prior to the trial, and have a BMI between 18-35 kg/m^2.

Inclusion Criteria

Your body mass index is within the range of 18 to 35 kilograms per square metre.

I have been diagnosed with adult-onset rheumatoid arthritis for at least 6 months.

I am taking 10-25 mg of methotrexate weekly for RA, with folic acid.

Timeline for a Trial Participant

Run-in

Participants undergo a run-in period to determine eligibility before randomization

4 to 6 weeks

1 visit (in-person)

Treatment

Participants receive SAR441566 or placebo added to methotrexate for 12 weeks

12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SAR441566

Trial Overview The study is testing SAR441566's effectiveness and safety in treating rheumatoid arthritis over a period of 12 weeks. It compares different doses of SAR441566 against a placebo while all participants continue their regular methotrexate therapy.

How Is the Trial Designed?

Group I: SAR441566 dose regimen D Experimental Treatment 1 Intervention

Participant will receive dose regimen D of SAR441566 for 12 weeks

Group II: SAR441566 dose regimen C Experimental Treatment 1 Intervention

Participant will receive dose regimen C of SAR441566 for 12 weeks

Group III: SAR441566 dose regimen B Experimental Treatment 1 Intervention

Participant will receive dose regimen B of SAR441566 for 12 weeks

Group IV: SAR441566 dose regimen A Experimental Treatment 1 Intervention

Participant will receive dose regimen A of SAR441566 for 12 weeks

Group V: Placebo Placebo Group 1 Intervention

Participant will receive SAR441566-matching placebo for 12 weeks

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

Sarilumab, a human monoclonal antibody targeting the IL-6α receptor, has shown significant efficacy in improving symptoms and function in rheumatoid arthritis patients who did not respond adequately to other treatments, with benefits observed over 52 weeks in 6 randomized clinical trials.

While sarilumab is effective, it is associated with common adverse events like infections and neutropenia, highlighting the need for careful monitoring and further long-term studies to fully understand its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update of sarilumb to treat rheumatoid arthritis based on randomized clinical trials: a systematic review. Aly, AM., Furst, DE.[2022]

In a phase III study involving 1670 patients with rheumatoid arthritis (RA) who did not respond to other treatments, sirukumab significantly improved symptoms, with 53.5% of patients on the 100 mg dose and 54.8% on the 50 mg dose achieving a 20% improvement in RA symptoms compared to 26.4% in the placebo group.

Sirukumab also effectively inhibited structural damage in joints, as shown by a significantly lower change in the modified Sharp/van der Heijde score at week 52, while maintaining a safety profile consistent with common adverse events like elevated liver enzymes and respiratory infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. Takeuchi, T., Thorne, C., Karpouzas, G., et al.[2022]

In a 5-year study involving 1197 patients with rheumatoid arthritis, sarilumab combined with methotrexate significantly reduced disease activity and inhibited radiographic progression compared to placebo, demonstrating sustained clinical efficacy over time.

The safety profile of sarilumab remained stable throughout the 5 years, with no increased infection rates despite some patients experiencing low neutrophil counts, indicating it is a safe long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. Genovese, MC., van der Heijde, D., Lin, Y., et al.[2020]

Tocilizumab, an IL-6 receptor inhibitor, has shown significant efficacy in treating rheumatoid arthritis (RA) through a series of progressively rigorous clinical trials, indicating its potential as a valuable therapy for this autoimmune disease.

The ongoing research into tocilizumab's long-term safety and effectiveness across diverse RA patient populations will further clarify its role and the potential of other IL-6 inhibitors in managing RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interleukin-6 inhibitors in the treatment of rheumatoid arthritis. Hennigan, S., Kavanaugh, A.[2022]

Current treatments for rheumatoid arthritis, including analgesics and immunomodulators, often have limited efficacy or cause significant side effects, leading to a need for safer alternatives.

The article reviews several new pharmaceutical agents under investigation, such as zileuton and tenidap for inflammation, and leflunomide and mycophenolic acid for immunosuppression, which may offer better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. Merkel, PA., Letourneau, EN., Polisson, RP.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06073093

NCT06073093 | A Study to Evaluate SAR441566 Efficacy ... It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate- ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06073093

A Study to Evaluate SAR441566 Efficacy and Safety in Adults ... It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166256/

First‐in‐Human Single and Multiple Ascending Dose ... 38. A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritis. <https://clinicaltrials.gov/study/NCT06073093>.

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1037983/full

An orally available small molecule that targets soluble TNF ... The combined data set clearly shows that oral administration of SAR441566 results in a dose dependent inhibition in signs of arthritis. SAR441566 dosed at 10 mg ...

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

balinatunfib (SAR441566) / Sanofi Balinatunfib, as the first clinically tested oral TNFR1 signal inhibitor, demonstrated a good safety profile along with favorable PK/PD characteristics.

6. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312881/a-study-to-evaluate-8/

A Study to Evaluate SAR441566 Efficacy and Safety Clinical Studies for Rheumatoid Arthritis , A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis.

7. clinicaltrials.eu clinicaltrials.eu/inn/sar441566/

Sar441566 – Application in Therapy and Current Clinical ... SAR441566 is an investigational drug being studied for its potential in treating various autoimmune conditions, including Crohn's disease, rheumatoid arthritis ...