SAR441566 for Rheumatoid Arthritis

(SPECIFI-RA Trial)

Recruiting at 155 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Must be taking: Methotrexate

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Immunologic disorder, Infections, Heart failure, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. 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-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

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.

What makes the drug SAR441566 unique for treating rheumatoid arthritis?

SAR441566 is unique because it targets the IL-6 pathway, similar to other treatments like sarilumab and sirukumab, but may have a different structure or binding affinity, potentially offering a novel approach to managing rheumatoid arthritis symptoms. ^{1 2 3 4 5}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• SAR441566 (Monoclonal Antibodies)

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. [2022]

3. England 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. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Interleukin-6 inhibitors in the treatment of rheumatoid arthritis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. [2007]