Not recruiting

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

Fast replyInvestigationalNo placebo

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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.

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
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
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)
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
check
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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Verified sites

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

Responsive
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Frankfurt, Germany
Verified
Hospital General Universitario De Valencia
Valencia, Spain
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

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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.

Lutikizumab

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create descriptions of individual medications. The trial data only indicates that it's a Phase 2 platform study for treating Rheumatoid Arthritis, but doesn't specify which targeted therapies are being tested. If you provide the names of the specific medications being studied in this trial, I can create detailed descriptions following the requested format: Medication Name – description of administration, status, indications, mechanism of action, and classification.

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.