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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Krankenhaus Porz Am Rhein gGmbH Cologne Germany

Other Sites

Site Name City Country Status
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Frankfurt Germany
Semmelweis University Budapest Hungary
Hospital General Universitario De Valencia Valencia Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
University Of Szeged Szeged Hungary
Hospital General Universitario Gregorio Maranon Madrid Spain
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Revita Kft. Budapest Hungary
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Kardiocentrum AGEL a.s. Kosice Slovakia
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Basurto Bilbao Spain
Medical Plus s.r.o. Uherske Hradiste Czechia
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Medman s.r.o. Martin Slovakia
Qualiclinic Kft. Budapest Hungary
Thermium s.r.o. Piestany Slovakia
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Malopolskie Centrum Kliniczne Cracow Poland
Complex Rendelo Med Zrt. Szekesfehervar Hungary
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
PV Medical Services s.r.o. Zlin Czechia
Vital-Medicina Kft. Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Mlazmtneo Iiixwnqgwj Cmnpyvdi Sqvdkcec Snm z ohji Warsaw Poland
Hvxfknyx Ucyvpaeaqbjiu dw A Cqatkp A Coruna Galicia Spain
Hsuxbqpd Uiiibkndpkxzy Mvdykdz Dr Vrbjzmkksx Santander Spain
Piem Tqoda Hhzkbrel Uxblobylueby Sabadell Spain
Szhjrocqrte Lihwxcgotwyeylfboiwg Gpi Wetzlar Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
31.10.2025
Germany Germany
Recruiting
31.10.2025
Hungary Hungary
Recruiting
31.10.2025
Poland Poland
Not recruiting
31.10.2025
Slovakia Slovakia
Not recruiting
31.10.2025
Spain Spain
Not recruiting
31.10.2025

Trial locations

Investigated Drugs:

Based on the provided data, there are no specific medications listed in the source material. The trial is described as a Phase 2 platform study of targeted therapies for rheumatoid arthritis, but the actual medications are not specified in the given data. Without specific medication information in the source data, I cannot provide descriptions of individual drugs or therapies.

The only information available indicates this is a study examining targeted therapies for treating moderate to severe rheumatoid arthritis, both as monotherapy and combination therapy, but the specific medications are not disclosed in the provided data.

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 ID:
2025-520721-21-00
Protocol code:
M25-056
Trial Phase:
Therapeutic exploratory (Phase II)

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