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New pill for rheumatoid arthritis passes first safety check in small study

NCT ID NCT05858788

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study tested a new oral drug called SAR441566 in 10 healthy Japanese men to see how safe it is and how the body processes it. The drug is being developed for rheumatoid arthritis, an autoimmune disease that causes joint pain and swelling. The study only looked at safety and drug levels in the blood, not whether it actually treats arthritis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR441566 (oral tablet)
What this could lead to
If successful, this could lead to a new oral treatment option for rheumatoid arthritis, helping control the disease with fewer side effects.
What could go wrong
This is a very early Phase 1 study in only 10 healthy men, not patients. It only checks safety and drug levels, not whether it works for arthritis. Many drugs fail in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

May 2023

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan. * Male participants between the ages of 18 and 55 years, inclusive * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests) * Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness. * Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study. * History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2 * Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Parexel International-Site Number:8400001

    Glendale, California, 91206, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.