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Study of lutikizumab and ravagalimab in adults with moderate to severe rheumatoid arthritis

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What is this trial about?

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

This clinical study focuses on patients with Rheumatoid Arthritis, a condition where the body's immune system mistakenly attacks the joints, causing pain, swelling, and stiffness. The study will test two medications: Lutikizumab and ravagalimab, which are given as injections under the skin. Some participants will receive a placebo instead of the active medications.

The purpose of this research is to evaluate how safe and effective these medications are in treating moderate to severe rheumatoid arthritis, either when used alone or in combination. The medications will be tested in patients who have previously tried other treatments for their condition but still have active disease symptoms.

During the study, participants will receive their assigned treatment for 12 months. All patients will continue taking methotrexate, a standard medication for rheumatoid arthritis, throughout the study period. The study will monitor how well the treatments work by measuring improvements in joint symptoms and overall disease activity.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive treatment for rheumatoid arthritis using one of the following medications:

    - Ravagalimab through subcutaneous injection (under the skin)

    - Lutikizumab through subcutaneous injection

    - A placebo (inactive substance) for comparison

    You will continue taking your current methotrexate medication at the same dose throughout the study

  2. Step 2

    12-week evaluation period

    Your response to the treatment will be monitored for 12 weeks

    The doctor will measure your improvement using several methods:

    - Checking if your joint symptoms have improved by 20%, 50%, or 70%

    - Measuring your overall disease activity

    - Testing your blood for signs of inflammation using a test called C-Reactive Protein (CRP)

    Regular assessments will track changes in your condition throughout this period

  3. Step 3

    Disease activity monitoring

    Your disease activity will be measured using two different methods:

    - Disease Activity Score-28 (DAS28): measures activity in 28 specific joints

    - Clinical Disease Activity Index (CDAI): another way to measure how active your arthritis is

    These measurements will help determine if you have achieved:

    - Low disease activity

    - Clinical remission (minimal to no active disease)

  4. Step 4

    Study completion

    The entire study is expected to run from October 2025 to February 2027

    Your participation will help evaluate how well these medications work for treating moderate to severe rheumatoid arthritis

    Regular monitoring of your health and safety will continue throughout the study period

Who can join the trial?

8 criteria

  • Must be an adult aged 18 years or older
  • Can be either male or female
  • Must have been previously treated for at least 3 months with at least one biological or targeted synthetic medication (special medications that target specific parts of the immune system) for rheumatoid arthritis but:
    • Still have active disease symptoms, OR
    • Had to stop the medication due to side effects or inability to tolerate it
    • Cannot have used more than 2 different biological or targeted synthetic medications in the past
    • Must be currently taking a stable dose of methotrexate (a common medication used to treat rheumatoid arthritis)
    • Must not be part of any vulnerable population groups
    • Must have moderate to severe active rheumatoid arthritis symptoms

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Current or recent serious infections, including tuberculosis (TB)
  • History of severe allergic reactions to medications
  • Active or recent cancer
  • Severe heart, liver, or kidney disease
  • Pregnancy or breastfeeding
  • Current treatment with other biological medications (specialized drugs that target specific parts of the immune system)
  • Uncontrolled high blood pressure
  • Active hepatitis B or C infection
  • History of blood disorders
  • Major surgery planned within 8 weeks of starting the study
  • Participation in another clinical trial within the past 30 days
  • Severe mental health conditions that could interfere with study participation
  • Alcohol or drug abuse within the past 6 months
  • Conditions that could interfere with study assessments
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Investigated drugs

  • Lutikizumab

    is an experimental drug being tested as a single treatment for adults with moderate to severe rheumatoid arthritis. It is given as a solution that is injected under the skin. In this study, researchers are looking to see if Lutikizumab can reduce joint pain, swelling, and damage, and whether it is safe for patients to use over time.

  • Ravagalimab

    (also known as USP/Ph. Eur.ABBV-323) is another experimental medication being evaluated for the same type of rheumatoid arthritis. Like Lutikizumab, it is administered as a subcutaneous injection. The trial will assess whether Ravagalimab can improve arthritis symptoms and halt disease progression, while also monitoring its safety profile.

What is already known about the treatment

  • Lutikizumab

    This medication is given as a solution for injection under the skin (subcutaneous injection). It is currently an investigational drug being studied in Phase 2 trials and is not yet approved for general medical use. It is being tested for the treatment of rheumatoid arthritis, a condition that causes joint pain and swelling. Lutikizumab works by attaching to specific proteins that cause inflammation, helping to reduce joint damage, and it belongs to the class of monoclonal antibodies that block interleukin‑1 activity.

  • Ravagalimab

    This drug is also administered as a solution for injection under the skin (subcutaneous injection) and can be given as an infusion. It is in the investigational stage, studied in Phase 2 trials, and has not been approved for routine clinical use. The medication is intended for rheumatoid arthritis to lessen pain and swelling in the joints. Ravagalimab blocks a key inflammatory protein, lowering the body’s inflammatory response, and it is classified as a monoclonal antibody that targets inflammatory pathways.

Investigated diseases

Rheumatoid Arthritis – A chronic inflammatory condition that primarily affects the joints throughout the body. The disease causes the immune system to mistakenly attack the body's own tissues, particularly the protective lining of the joints, leading to inflammation and swelling. Over time, this ongoing inflammation causes thickening of the joint lining, eventually damaging both cartilage and bone within the joints. The condition typically affects multiple joints symmetrically, meaning if one hand is affected, the other usually is too. Common symptoms include joint pain, stiffness (especially in the morning), swelling, and warmth in affected joints. The disease can also cause fatigue, occasional fever, and general weakness.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520721-21-00Protocol codeM25-056Estimated enrolment204 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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