Testing a new injection for lung disease linked to rheumatoid arthritis or scleroderma

Plain-English translation of NCT06189495 on ClinicalTrials.gov ↗ · Source last updated January 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a new medication called Genakumab to see if it can help treat lung disease that develops in people with rheumatoid arthritis or systemic sclerosis (a connective tissue disease). The medication is given as an injection under the skin every 4 weeks. Researchers want to understand whether this treatment is safe, well-tolerated, and actually helps improve lung function in patients with these conditions.

Lung disease is a serious complication that can develop in people with rheumatoid arthritis and systemic sclerosis, and current treatment options are limited. This trial is exploring whether the new treatment might offer patients another option to slow or improve this lung involvement.

Do you qualify?

You likely qualify if…

you have been diagnosed with rheumatoid arthritis or systemic sclerosis according to official medical criteria
you have lung disease (confirmed by a CT scan within the past year) related to your rheumatoid arthritis or systemic sclerosis
your lung function is at least 40% of what is expected for your age and size (measured by breathing tests)
you are between 18 and 75 years old
you agree to use reliable birth control during the trial and for 6 months after your last dose if you are of childbearing age
you are willing to keep any other immune-suppressing medications you take at a stable dose throughout the study

You likely don't qualify if…

you have a known allergy to the study drug or other biological agents, or a history of severe allergic reactions
you have other types of airway or lung problems, such as asthma or significant airway obstruction
you are taking high doses of steroids (more than 15 mg of prednisone per day) or certain other immunosuppressive medications within recent weeks or months
you have significant pulmonary hypertension (high blood pressure in the lungs) or signs of right heart failure
you have an active infection requiring treatment, active tuberculosis, a bleeding disorder, or are taking blood-thinning medications

What participation looks like

If you join this trial, you will receive an injection of the medication (or placebo) under your skin in the abdomen every 4 weeks. The main study phase lasts 24 weeks, during which you'll receive 6 injections total. After that, you may continue receiving the medication in an open-label phase (where you know you're getting the active treatment) until the study ends or until the doctors determine it's no longer beneficial or causing problems. Throughout the trial, you'll have visits to check your lung function, blood work, and overall health.

AI-generated summary from trial data · Jun 14, 2026 · Not medical advice

Trial locations(4 sites)

China

Peking University Third Hospital, Beijing, Beijing Municipality

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei

Qilu Hospital of Shandong University, Jinan, Shandong

West China Hospital of Sichuan University, Chengdu, Sichuan