Resolve-Lung
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis
IRAS ID
1005105
Contact name
Laure Maury
Contact email
Sponsor organisation
Kinevant Sciences GmbH
Eudract number
2021-004794-31
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out how well the study drug namilumab works and how safe it is for the treatment of chronic pulmonary sarcoidosis. In addition, the study may also provide a scientific basis for advising and treating patients with namilumab.
Namilumab is an experimental drug which is not approved by Health Authorities including for the treatment of chronic pulmonary sarcoidosis. Experimental means that namilumab is not yet approved as a medicine and not yet available for prescription in your country.
Sarcoidosis is a rare condition in which granulomas (small clumps of white blood cells and other tissue) appear in one or more organs of the body. If many granulomas form in an organ, the organ may not work normally. Most commonly this disease will affect the lungs, but it can also affect the eyes, skin, heart, and other organs. When sarcoidosis affects the lungs, the major symptoms are shortness of breath and coughing. These symptoms will develop gradually and for some people may continue over time and get worse, to the point where they become severely affected and require long-term treatment. This is known as chronic pulmonary sarcoidosis.
The exact cause of sarcoidosis is unknown. However, it is thought that sarcoidosis happens due to the over-activity of the immune system leading to granulomas. A protein called granulocyte-macrophage colony-stimulating factor (GM-CSF) is believed to be important in regulating the process of granuloma formation.
The study drug, namilumab, is a human monoclonal antibody (mAb) that binds to GM-CSF in the blood and tissues, limiting the ability of GM-CSF to form granulomas. The idea is that the study drug may reduce your immune system’s response and prevent ongoing damage to the lungs and other affected organs from sarcoidosis.
Patients, who qualify for this study will be randomly assigned by a computer, to one of the two treatment groups:
• Treatment 1: Namilumab 150 mg
• Treatment 2: PlaceboLAY SUMMARY OF STUDY RESULTS:
"There were 106 participants with pulmonary sarcoidosis who received treatment in this study. The participants were between 26 and 79 years old when they joined. There were 61 men and 45 women. Of these participants, 52 received namilumab and 54 received the placebo. Both treatments were given as injections. The placebo was an injection with no drug in it.In the first part of the study (Part 1), the participants received their assigned treatment for about 6 months. The main goal of the study was to learn whether namilumab helped control participants’ sarcoidosis better than the placebo did in Part 1.
Participants who finished Part 1 were allowed to move on to Part 2. In Part 2, all of the participants were to receive namilumab once a month for another 6 months. Part 2 of the study was stopped early. This happened because researchers looked at the results from Part 1 and learned that namilumab did not help participants more than the placebo did.
Another goal of the study was to evaluate the safety and tolerability of namilumab. One way to do this is to look at any new or worsening health issues that participants had during the study that study doctors thought might have been related to their study treatment. These health issues are called “adverse reactions”. Some adverse reactions are considered “serious”. Examples of serious adverse reactions are those that are life-threatening, cause lasting problems, or need hospital care.
None of the participants in this study had a serious adverse reaction.
A summary of the non-serious adverse reactions that participants had in Part 1 and Part 2 is below.
In Part 1:
20 of the 52 participants who received namilumab (38%) had at least 1 adverse reaction. One of these participants stopped taking namilumab because of an adverse reaction. The most common adverse reaction with namilumab was pain at the study drug injection site. This adverse reaction happened to 5 participants (10%) in the namilumab group and 2 participants (4%) in the placebo group.
-16 of the 54 participants who received the placebo (30%) had at least 1 adverse reaction. The most common adverse reaction with the placebo was fatigue. This adverse reaction happened to 3 participants (6%) in the placebo group and 2 participants (4%) in the namilumab group.
There were 96 participants who moved on to Part 2. This included 47 participants who received namilumab in Part 1 and 49 participants who received the placebo in Part 1.In Part 2:
9 of the 47 participants (19%) who received namilumab in Part 1 and Part 2 had at least 1 adverse reaction. One of these participants stopped taking namilumab because of an adverse reaction.
11 of the 49 participants (22%) who received the placebo in Part 1 and namilumab in Part 2 had at least 1 adverse reaction.
There were no adverse reactions in Part 2 that affected more than 2 participants.The results of this study helped researchers learn more about the effects of namilumab on chronic pulmonary sarcoidosis. Clinical studies like this one help researchers learn what they cannot learn in a lab, which is how potential new treatments affect the people who take them. Also, because this study was one of the largest studies done with participants who have pulmonary sarcoidosis, it may help researchers learn more about how to conduct studies in pulmonary sarcoidosis in the future.
This summary only shows the results from this study. Other studies might have different results. Researchers and health authorities look at the results of multiple studies to understand how a treatment works and how safe it is for patients to take.
No other clinical studies with namilumab in pulmonary sarcoidosis are currently planned or under way.
This study started in August 2022 and ended in April 2025. It was done in 7 countries: the United States, Türkiye, the United Kingdom, Belgium, Germany, France, and the Netherlands.
For more information about this study, please visit this website:
https://euclinicaltrials.eu/ - Click on “Search clinical trials”, enter this ID number into the top search field: 2024-511115-25-00, scroll down, and then click “Search”. Click on the trial title, and then click on “Trial results.” Or email the study sponsor: kinevant.resolve-lung@kinevant.com"REC name
London - South East Research Ethics Committee
REC reference
22/LO/0602
Date of REC Opinion
27 Oct 2022
REC opinion
Further Information Favourable Opinion