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Rheumatoid ArthritisPhase 2SPECIFI-RANCT06073093

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

A Phase 2 study testing SAR441566 in people with Rheumatoid Arthritis, run by Sanofi at 102 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
SAR441566
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
102 sitesin 19 countries
Study dates
7 Nov 2023to 2 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
  • Moderate-to-severely active RA, defined as:
  • persistently active disease >= 6 tender and >= 6 swollen joints
  • high sensitivity C-reactive protein ≥ 4 mg/L
  • Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit
  • MTX - 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs) and folic/folinic acid (as part of MTX regimen)
  • Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards
  • BMI within the range [18 - 35] kg/m^2 (inclusive)

Who cannot join

  • Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement
  • Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy
  • Uncontrolled polymyalgia rheumatica or fibromyalgia
  • History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
  • Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
  • History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol
Show all 27Show fewer
  • History of solid organ transplant
  • History of alcohol or drug abuse within the past 2 years
  • History of diagnosis of demyelinating disease such as but not limited to:
  • Multiple Sclerosis
  • Acute Disseminated Encephalomyelitis
  • Balo's Disease (Concentric Sclerosis)
  • Charcot-Marie-Tooth Disease
  • Guillain-Barre Syndrome
  • human T-lymphotropic virus 1 Associated Myelopathy
  • Neuromyelitis Optica (Devic's Disease)
  • Planned surgery during the treatment period
  • Participants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
  • Vaccination with live or live-attenuated virus vaccine within 3 months prior to screening or plan to receive one during the trial including at least 3 months after the last dose of study drug
  • Any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial
  • Participant with personal or family history of long QT syndrome
  • Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin
  • Previous or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RA
  • Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.
  • Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening
  • Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening
  • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial locations and contacts

102 sites in 19 countries.

102 sites in 19 countries

United States17 sites

  • Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400012

    Charlotte, North Carolina, 28207

  • Altoona Center for Clinical Research- Site Number : 8400002

    Duncansville, Pennsylvania, 16635

  • Prolato Clinical Research Center- Site Number : 8400021

    Houston, Texas, 77054

  • AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400031

    Irving, Texas, 75039

  • UF Health Deerwood Park- Site Number : 8400020

    Jacksonville, Florida, 32256

  • Life Clinical Trials- Site Number : 8400028

    Margate, Florida, 33063

  • Future Care Solution - Miami- Site Number : 8400019

    Miami, Florida, 33142

  • Innovia Research Center, Inc- Site Number : 8400026

    Miramar, Florida, 33027

  • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400023

    Northridge, California, 91324

  • Integral Rheumatology and Immunology Specialists- Site Number : 8400010

    Plantation, Florida, 33324

  • American Indian Clinical Trials Research Network - Rapid City- Site Number : 8400022

    Rapid City, South Dakota, 57701

  • Perceptive Pharma Research- Site Number : 8400009

    Richmond, Texas, 77407

  • Inspire Santa Fe Medical Group- Site Number : 8400029

    Santa Fe, New Mexico, 87505

  • Carolina Specialty Care- Site Number : 8400007

    Statesville, North Carolina, 28625

  • Low Country Rheumatology- Site Number : 8400018

    Summerville, South Carolina, 29486

  • Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8400017

    Tampa, Florida, 33606

  • Inland Rheumatology & Osteoporosis Medical Group- Site Number : 8400004

    Upland, California, 91786

Other trials in United States

Japan10 sites

  • Investigational Site Number : 3920002

    Fuchū, Tokyo, 183-8524

  • Investigational Site Number : 3920007

    Kamogawa, Chiba, 296-0041

  • Investigational Site Number : 3920004

    Kawachi-Nagano, Osaka, 586-0008

  • Investigational Site Number : 3920008

    Nagasaki, 850-0832

  • Investigational Site Number : 3920005

    Nagoya, Aichi-ken, 457-8511

  • Investigational Site Number : 3920006

    Sapporo, Hokkaido, 060-0001

  • Investigational Site Number : 3920009

    Sapporo, Hokkaido, 063-0811

  • Investigational Site Number : 3920011

    Tokorozawa, 359-1111

  • Investigational Site Number : 3920003

    Toyonaka, Osaka, 560-8552

  • Investigational Site Number : 3920001

    Toyota, 470-0396

Other trials in Japan

Chile9 sites

  • Investigational Site Number : 1520001

    La Serena, Coquimbo Region, 1720430

  • Investigational Site Number : 1520003

    Osorno, Los Lagos Region, 5311092

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8320325

  • Investigational Site Number : 1520009

    Santiago, 8330032

  • Investigational Site Number : 1520002

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520005

    Valdivia, Los Ríos Region, 5110683

  • Investigational Site Number : 1520007

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Argentina8 sites

  • Investigational Site Number : 0320005

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320004

    Buenos Aires, Buenos Aires F.D., 1114

  • Investigational Site Number : 0320001

    Buenos Aires, Buenos Aires F.D., 1430

  • Investigational Site Number : 0320003

    Buenos Aires, 1121

  • Investigational Site Number : 0320007

    Buenos Aires, 1221

  • Investigational Site Number : 0320006

    Mar del Plata, 7600

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, 4000

  • Investigational Site Number : 0320002

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Spain8 sites

  • Investigational Site Number : 7240001

    A Coruña, A Coruña [La Coruña], 15006

  • Investigational Site Number : 7240008

    Chiclana de la Frontera, 11139

  • Investigational Site Number : 7240007

    Madrid, 28003

  • Investigational Site Number : 7240003

    Málaga, 29010

  • Investigational Site Number : 7240004

    Sabadell, Castille and León, 08208

  • Investigational Site Number : 7240002

    Santiago de Compostela, A Coruña [La Coruña], 15702

  • Investigational Site Number : 7240006

    Santiago de Compostela, A Coruña [La Coruña], 15705

  • Investigational Site Number : 7240005

    Seville, Andalusia, 41010

Other trials in Spain

India7 sites

  • Investigational Site Number : 3560006

    Ahmedabad, 380016

  • Investigational Site Number : 3560002

    Bengaluru, 560079

  • Investigational Site Number : 3560001

    Chennai, 600004

  • Investigational Site Number : 3560010

    Hyderabad, 500072

  • Investigational Site Number : 3560007

    Kolkata, 700020

  • Investigational Site Number : 3560011

    Nashik, 422101

  • Investigational Site Number : 3560005

    Surat, 395002

Other trials in India

Poland6 sites

  • Investigational Site Number : 6160003

    Bialystok, Podlaskie Voivodeship, 15-879

  • Investigational Site Number : 6160005

    Bytom, Silesian Voivodeship, 41-902

  • Investigational Site Number : 6160006

    Grodzisk Mazowiecki, 05-825

  • Investigational Site Number : 6160001

    Lublin, Lubusz Voivodeship, 20-363

  • Investigational Site Number : 6160002

    Lublin, Lubusz Voivodeship, 20-607

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 61-397

Other trials in Poland

South Africa6 sites

  • Investigational Site Number : 7100002

    Cape Town, 7405

  • Investigational Site Number : 7100003

    Cape Town, 7500

  • Investigational Site Number : 7100001

    Pretoria, 0002

  • Investigational Site Number : 7100005

    Pretoria, 0002

  • Investigational Site Number : 7100004

    Pretoria, 0184

  • Investigational Site Number : 7100007

    Stellenbosch, 7600

Other trials in South Africa

Brazil5 sites

  • Centro de Estudos em Terapias Inovadoras- Site Number : 0760004

    Curitiba, Paraná, 80030-110

  • Centro Mineiro de Pesquisa- Site Number : 0760003

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital São Lucas Copacabana- Site Number : 0760007

    Rio de Janeiro, 22061-080

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760005

    Rio de Janeiro, 22241-180

  • Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760001

    São Paulo, 04265-000

Other trials in Brazil

Czechia5 sites

  • Investigational Site Number : 2030006

    Brno, 638 00

  • Investigational Site Number : 2030002

    Ostrava, 702 00

  • Investigational Site Number : 2030008

    Pardubice, 530 02

  • Investigational Site Number : 2030001

    Prague, 128 00

  • Investigational Site Number : 2030003

    Uherské Hradiště, 686 01

Other trials in Czechia

Canada4 sites

  • Investigational Site Number : 1240001

    Brampton, Ontario, L6T 0G1

  • Investigational Site Number : 1240006

    Calgary, Alberta, T2N 4L7

  • Investigational Site Number : 1240002

    Sherbrooke, Quebec, J1G 2E8

  • Investigational Site Number : 1240004

    Windsor, Ontario, N8X 1T3

Other trials in Canada

China3 sites

  • Investigational Site Number : 1560004

    Chengdu, 610041

  • Investigational Site Number : 1560003

    Hefei, 230001

  • Investigational Site Number : 1560001

    Shanghai, 200040

Other trials in China

Germany3 sites

  • Investigational Site Number : 2760002

    Berlin, 12161

  • Investigational Site Number : 2760001

    Hamburg, 20095

  • Investigational Site Number : 2760003

    Ratingen, 40882

Other trials in Germany

Greece3 sites

  • Investigational Site Number : 3000001

    Athens, 124 62

  • Investigational Site Number : 3000002

    Heraklion, 711 10

  • Investigational Site Number : 3000003

    Thessaloniki, 546 36

Other trials in Greece

Mexico3 sites

  • Investigational Site Number : 4840001

    Chihuahua City, 31210

  • Investigational Site Number : 4840003

    Mérida, 97070

  • Investigational Site Number : 4840002

    Mexico City, Mexico City, 06700

Other trials in Mexico

Slovakia2 sites

  • Investigational Site Number : 7030003

    Nové Mesto nad Váhom, 915 01

  • Investigational Site Number : 7030001

    Piešťany, 921 01

Other trials in Slovakia

Georgia1 site

  • Investigational Site Number : 2680001

    Tbilisi, 0112

Other trials in Georgia

Mauritius1 site

  • Investigational Site Number : 4800001

    Vacoas, 72218

Other trials in Mauritius

Puerto Rico1 site

  • Caribbean Medical Research Center- Site Number : 8400027

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis

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.

Read the detailed description

The overall study duration for each participant will be approximately up to 149 days.

Being tested
SAR441566, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR441566Drug

    Tablet

  • PlaceboDrug

    Tablet

Study groups in NCT06073093
Study groupRoleWhat they receive
SAR441566 dose regimen AExperimentalParticipant will receive dose regimen A of SAR441566 for 12 weeks
Receives: Drug: SAR441566
SAR441566 dose regimen BExperimentalParticipant will receive dose regimen B of SAR441566 for 12 weeks
Receives: Drug: SAR441566
SAR441566 dose regimen CExperimentalParticipant will receive dose regimen C of SAR441566 for 12 weeks
Receives: Drug: SAR441566
SAR441566 dose regimen DExperimentalParticipant will receive dose regimen D of SAR441566 for 12 weeks
Receives: Drug: SAR441566
PlaceboPlacebo comparatorParticipant will receive SAR441566-matching placebo for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12

    ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.

    Measured: Baseline to Week 12

Secondary outcomes (5)

  1. Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12

    The DAS28-CRP is a composite endpoint. DAS28-CRP is comprised of clinical assessment of 28 swollen joint count (SJC)/ tender joint count (TJC), patient assessment of global disease activity and CRP mg/dL. It is a continuous measure allowing for measurement of absolute change in disease burden and percentage improvement.

    The DAS28 can be calculated using the following formula:

    DAS28 = 0.56 x 28TJC + 0.28 x 28SJC + 0.36 x Log(CRP+1) + 0.014 x GH + 0.96 The DAS28 provides a number indicating the current activity of the RA. A DAS28 above 5.1 means high disease activity, whereas a DAS28 below 3.2 indicates low disease activity and a DAS28 below 2.6 means disease remission.

    Measured: Baseline to Week 12

  2. Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12

    ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR50 is ≥ 50% improvement. ACR50 responders include ACR20 responders

    Measured: Baseline to week 12

  3. Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

    Incidence of TEAEs, SAEs, and AESIs

    Measured: Baseline to week 14

  4. Plasma pre-dose concentrations of SAR441566

    Measured: Week 2 to week 12

  5. Plasma post-dose concentrations of SAR441566

    Measured: Week 0 to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start7 Nov 2023
  3. Primary completion18 Jun 2025
  4. Study completion2 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06073093
Sponsor's protocol ID
DRI17821
Other IDs
U1111-1288-8641, 2023-503910-60-00, 2023
Acronym
SPECIFI-RA
Status last verified
Jul 2025
First submitted
4 Oct 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441566 in people with Rheumatoid Arthritis, run by Sanofi at 102 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Japan, Chile, Argentina, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06073093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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