Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Rosnilimab for Patients with Moderate to Severe Rheumatoid Arthritis

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Rosnilimab in individuals with Moderate to Severe Rheumatoid Arthritis. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study aims to evaluate how effective and safe Rosnilimab is in treating this condition. Rosnilimab is administered as a solution for injection under the skin.

The trial is designed to compare the effects of Rosnilimab with a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either Rosnilimab or the placebo. The study will last for several weeks, during which participants will receive regular injections and attend scheduled visits for monitoring. The main goal is to observe changes in the severity of rheumatoid arthritis symptoms over time.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they might experience. The study will assess various outcomes, such as the reduction in joint pain and swelling, and the overall improvement in disease activity. The results will help determine the potential benefits of Rosnilimab for people living with moderate to severe rheumatoid arthritis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the study medication, rosnilimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The study medication, rosnilimab, is administered as a solution for injection. It is given subcutaneously, which means it is injected under the skin.

    The dosage and frequency of administration will be determined by the study protocol and communicated to the participant at the start of the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring and assessments to evaluate the effectiveness and safety of the treatment.

    These assessments will include measuring changes in disease activity using the DAS28-CRP score, which is a measure of rheumatoid arthritis activity based on joint counts and blood tests.

  4. Step 4

    Primary evaluation

    The primary evaluation will occur at Week 12, where the main focus will be on the mean change from baseline in the DAS28-CRP score.

    This evaluation will help determine the primary efficacy of the treatment.

  5. Step 5

    Secondary evaluations

    Secondary evaluations will also take place at Week 12, assessing various response rates such as ACR20, ACR50, and ACR70, which indicate different levels of improvement in rheumatoid arthritis symptoms.

    Additional assessments will include the proportion of participants achieving low disease activity or remission based on DAS28-CRP and CDAI scores.

  6. Step 6

    Completion of study

    The study is expected to conclude by March 2026. Participants will be informed of the study's outcomes and any relevant findings related to their health and treatment.

Who can join the trial?

15 criteria

  • The person must be an adult, male or female, who is 18 years or older when they agree to join the study.
  • If the person is a woman who can have children, she must have a negative pregnancy test before starting the study and agree to use a strong method of birth control during the study and for 24 weeks after the last dose of the study treatment.
  • Women must agree not to donate eggs during the study and for 24 weeks after the last dose of the study treatment.
  • Men must use a condom during any sexual activity that could lead to pregnancy and use condoms with spermicide from the first dose of the study treatment until 150 days after the last dose if they are sexually active with a woman who can have children.
  • Men must agree not to donate sperm during the study and for 150 days after the last dose of the study treatment.
  • The person must be willing to participate, not be restricted by any local laws, and be able to give written consent to join the study.
  • The person must be willing to follow all study procedures and be available for the entire duration of the study.
  • The person must have a clinical diagnosis of active **Rheumatoid Arthritis (RA)**, which is a condition that causes joint pain and swelling, for at least 3 months before starting the study.
  • The person must be considered in good health by the study doctor, except for their RA, based on their medical history, lab tests, physical exam, and heart test results.
  • The person must have a positive test result for **Rheumatoid Factor (RF)** or antibodies to **Cyclic Citrullinated Peptide (CCP)**, which are markers often found in people with RA.
  • The person must have moderate to severe RA, shown by having at least 6 tender and 6 swollen joints at the start of the study.
  • The person must have a **high-sensitivity C-reactive protein (hs-CRP)** level of 3 mg/L or higher, which is a marker of inflammation in the body.
  • The person must be taking at least one, but not more than two, specific medications for RA for at least 3 months before the study and be on stable doses for at least 8 weeks before starting the study. These medications include Methotrexate, Leflunomide, Sulfasalazine, Hydroxychloroquine, or Chloroquine.
  • The person must meet certain criteria for **Tuberculosis (TB)** screening, which is a serious lung infection. They should have no history of active or latent TB, or if they have a history of latent TB, they must have completed or be receiving treatment for it. They must also have a negative TB test result before starting the study.
  • The person must have no signs of cancer or active infections, including TB, based on a chest X-ray or CT scan done within 6 months before starting the study.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other experimental drug within the last 30 days.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of allergic reactions to similar medications.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who have had a major surgery in the past three months.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Rosnilimab is a medication being studied for its effectiveness and safety in treating moderate to severe rheumatoid arthritis. It is designed to help reduce inflammation and pain in the joints, which are common symptoms of this condition. The trial aims to determine how well this medication works compared to not receiving the active treatment.

What is already known about the treatment

Rosnilimab – Rosnilimab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe rheumatoid arthritis. The medication works by targeting specific proteins in the immune system to reduce inflammation and slow down joint damage. It is classified as a biologic agent, which means it is derived from living organisms and designed to interfere with specific pathways in the immune response.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504564-42-00Protocol codeANB030-203Estimated enrolment420 patientsSponsorAnaptysbio Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).