In short

This article provides information about 2 ongoing clinical trials investigating treatments for rheumatic disorders. The trials are testing different approaches, including treatment for lung complications associated with systemic autoimmune rheumatic diseases and pain management in children with acute pain symptoms that may accompany rheumatic conditions.

Clinical trial locations

Austria
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
France
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
Germany
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
Italy
- Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
Netherlands
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
Norway
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases
Spain
- Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases

Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases

This clinical trial is investigating whether a medication called nerandomilast can help people who have developed a lung condition called Interstitial Lung Disease as a result of certain autoimmune conditions. These conditions cause the immune system to mistakenly attack the body's own tissues, leading to inflammation and scarring in the lungs, which can make breathing difficult.

Main inclusion criteria:

Participants must have a diagnosis of Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Disease, including conditions such as Rheumatoid Arthritis, Systemic Sclerosis (without anticentromere antibodies), Idiopathic Inflammatory Myopathy, Sjögren's disease, or Mixed Connective Tissue Disease
The lung damage must be visible on a high-resolution CT scan showing a specific pattern called fibrotic ILD
Lung function tests must show that the Forced Vital Capacity is at least 45% of normal and the ability to transfer oxygen is at least 25% of normal
Participants must have been on stable immune-suppressing treatment for at least 6 months (or 3 months for those with inflammatory myopathy), without improvement in lung function
If taking nintedanib, the dose must have been stable for at least 12 weeks

Main exclusion criteria:

Other serious health conditions that could interfere with the study
Recent infection requiring antibiotic treatment
Cancer diagnosis within the past five years (except certain skin cancers)
Pregnancy or breastfeeding
History of drug or alcohol abuse in the past year
Participation in another clinical trial
Major surgery in the past three months
Known allergy to the study medication or its ingredients

Focus and goal: The trial will last 26 weeks and aims to determine whether nerandomilast can reduce lung damage and improve lung function in people with autoimmune disease-related lung problems. Participants will receive either nerandomilast or a placebo (an inactive substance) in tablet form. Regular assessments will include detailed lung scans and monitoring of symptoms such as cough and shortness of breath. The study is double-blind, meaning neither participants nor doctors will know who is receiving the active medication until the study ends.

Investigational drugs: The main drug being tested is nerandomilast, an anti-inflammatory medication that works by modulating inflammatory pathways that contribute to lung tissue damage. The trial also involves nintedanib, which is already known to help slow down the worsening of lung function in certain lung conditions, and is being studied to see if it can provide better outcomes when used alongside other treatments.

Study Comparing the Speed of Action of Ibuprofen Lysine and Ibuprofen in Treating Acute Pain in Children

This clinical trial focuses on comparing how quickly two different forms of ibuprofen work to relieve acute pain in children. The study compares ibuprofen lysine suspension with regular ibuprofen suspension, both commonly used to treat pain and reduce fever in children.

Main inclusion criteria:

Children between 4 and 12 years old
Admitted to the emergency room with acute pain as a main or accompanying symptom, including sore throat, headache, ear pain, toothache, or pain from an injury
Pain level of 4 or higher on a 10-point scale (adjusted for age)
Written informed consent from parents or guardians, and from the child or adolescent where applicable
Willingness and ability to follow study requirements

Main exclusion criteria:

Other serious health conditions that might interfere with the study
Currently taking other medications that might affect study results
Allergies to ibuprofen or similar medications
History of stomach problems such as ulcers or bleeding
Kidney or liver problems
Asthma that is worsened by aspirin or other non-steroidal anti-inflammatory drugs
Participation in another clinical trial

Focus and goal: The primary goal is to evaluate how quickly each medication provides pain relief, with the first assessment taking place just five minutes after administration. Additional assessments will be conducted at 10, 20, and 30 minutes to further evaluate the effectiveness. The study uses age-appropriate pain scales such as the Wong-Baker Faces Pain Scale and the Numerical Rating Scale. It is designed as a single-blind study, meaning participants do not know which medication they are receiving, to ensure unbiased results. Throughout the study, children will be monitored for any side effects.

Investigational drugs: Lysin ibuprofen suspension is a liquid form of ibuprofen with lysine added to help the medication be absorbed faster by the body, potentially leading to quicker pain relief. It is being compared to standard ibuprofen suspension, a common pain reliever and anti-inflammatory medication used to reduce fever and relieve pain from various conditions including headache, toothache, and injuries.

Summary

The two ongoing clinical trials address different aspects of conditions related to or accompanying systemic autoimmune diseases. The first trial is a multi-country study spanning seven European nations (Germany, Netherlands, Austria, France, Spain, Italy, and Norway) and focuses specifically on lung complications that can develop in people with autoimmune conditions. This represents a significant area of research, as lung involvement can be a serious complication that affects quality of life and survival in people with these conditions.

The second trial, conducted in Italy, addresses the important aspect of pain management in children, which may be relevant for pediatric patients experiencing acute pain symptoms that can accompany various conditions. Both trials demonstrate the ongoing efforts to improve treatment options, whether by developing new medications for complex lung complications or by optimizing pain relief strategies for younger patients.

The nerandomilast trial is particularly notable for its broad geographic scope and its focus on a specific complication that affects multiple autoimmune conditions, potentially benefiting a wider patient population if successful.

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