In short
Nerandomilast (also known as BI 1015550) is an investigational drug currently being tested in clinical trials for treating lung fibrosis, particularly in patients with systemic autoimmune rheumatic diseases. These trials aim to determine how effective and safe nerandomilast is in managing interstitial lung diseases (ILDs), a group of disorders that cause scarring of lung tissue. The ongoing studies examine not only the drug's ability to slow disease progression but also how it interacts with other medications and how its formulation affects its absorption. For patients with lung fibrosis who haven't responded well to standard treatments, nerandomilast may represent a promising alternative therapy currently under investigation.
Key points
- Nerandomilast is an investigational drug currently being tested in clinical trials for treating interstitial lung diseases associated with systemic autoimmune rheumatic conditions. The main trial is studying patients who haven't improved with standard immunosuppressive treatments, comparing the effects of twice-daily nerandomilast tablets versus placebo over 26 weeks. Researchers are primarily measuring changes in lung tissue scarring using specialized imaging techniques and lung function tests. Additional studies are examining how nerandomilast interacts with other medications like bosentan and carbamazepine, and how different formulations and food affect the drug's absorption. These trials aim to determine if nerandomilast could be an effective treatment option for this difficult-to-treat form of lung fibrosis.
At a glance
- Drug Name
- Nerandomilast (also known as BI 1015550)
- Conditions Studied
- Interstitial Lung Diseases (ILDs), specifically those associated with Systemic Autoimmune Rheumatic Diseases (SARD-ILD)
- Target Population
- Adults 18+ with lung fibrosis related to systemic autoimmune rheumatic disease who show no improvement after standard immunosuppressant treatment
- Administration
- Oral tablets taken twice daily
- Main Study Duration
- 26 weeks (approximately 7.5 months including follow-up)
- Primary Outcome Measures
- Change in quantitative interstitial lung disease (QILD) score measured via high-resolution computed tomography
- Secondary Outcome Measures
- Changes in lung fibrosis patterns (QLF), ground glass opacities (QGGO), forced vital capacity (FVC), symptom scores for breathing and cough, and occurrence of infection-related adverse events
- Additional Studies
- Drug interaction studies with bosentan and carbamazepine; comparison of different formulations; effects of food on drug absorption
- Current Status
- Investigational (in clinical trials)
What is Nerandomilast?
Nerandomilast (also known as BI 1015550) is an investigational medication being studied for the treatment of lung fibrosis related to autoimmune rheumatic diseases. It is currently undergoing clinical trials to evaluate its safety and effectiveness. As an investigational drug, it has not yet received full approval from regulatory agencies for widespread use, but the ongoing research aims to determine if it can help patients with specific lung conditions.
What Conditions Does Nerandomilast Treat?
Nerandomilast is being studied primarily for the treatment of Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD). This includes lung fibrosis (scarring) that develops as a complication of rheumatic diseases. Specifically, it is being investigated for:
- Interstitial Lung Diseases (ILD) - a group of disorders that cause scarring of lung tissue, making breathing difficult
- Interstitial Lung Disease secondary to Systemic Sclerosis (also known as scleroderma) - where lung scarring occurs as a complication of this autoimmune disease
These conditions typically affect adults and can significantly impact quality of life by causing symptoms like shortness of breath, cough, and fatigue. Nerandomilast is being studied in patients who haven't shown improvement with standard immunosuppressant treatments.
How Nerandomilast Works
While the specific mechanism isn't fully detailed in the clinical trial information, Nerandomilast appears to target the underlying processes involved in lung fibrosis. The medication is being studied for its potential to:
- Reduce lung scarring and inflammation
- Improve lung function in patients with rheumatic disease-related lung conditions
- Work alongside existing immunosuppressant treatments for the underlying rheumatic disease
The ongoing clinical trials are designed to measure how effectively Nerandomilast can slow or reduce the progression of lung damage compared to placebo (inactive treatment).
How Nerandomilast is Administered
Based on the clinical trial information, Nerandomilast is administered as:
- Oral tablets taken twice daily
- Film-coated tablets (in some trials)
In the main clinical study for SARD-ILD, participants take the medication twice daily for 26 weeks (about 6 months). Different formulations of the tablets are also being tested to determine the best way to administer the medication.
Current Clinical Research
Nerandomilast is currently being studied in several clinical trials:
- SARD-ILD Study: A double-blind, randomized, placebo-controlled trial evaluating the effectiveness and safety of Nerandomilast over 26 weeks in patients with lung fibrosis related to autoimmune rheumatic diseases. Participants are randomly assigned to receive either Nerandomilast or a placebo while continuing their standard immunosuppressant treatments.
- Platform Clinical Study for Conquering Scleroderma: A multicenter study evaluating various investigational products, including Nerandomilast, for interstitial lung disease secondary to systemic sclerosis (scleroderma). This study will follow participants for 52 weeks to evaluate changes in lung function.
- Formulation and Food Effect Studies: Research examining different tablet formulations of Nerandomilast and how food might affect how the body absorbs and processes the medication.
- Drug Interaction Studies: Investigations into how Nerandomilast interacts with other medications like bosentan and carbamazepine.
These clinical trials involve various assessments, including lung function tests, chest imaging, and questionnaires about symptoms and quality of life, to determine if Nerandomilast is effective and safe.
Drug Interactions
Researchers are studying how Nerandomilast interacts with other medications. Specific studies include:
- Bosentan: A study is investigating how bosentan (a moderate Cytochrome P450 3A inducer) affects the pharmacokinetics (how the body processes the drug) of Nerandomilast.
- Carbamazepine: Another study is looking at how carbamazepine might influence the amount of Nerandomilast in the blood.
These studies are important because they help researchers understand potential drug interactions that could affect how Nerandomilast works in patients who may be taking multiple medications.
Effects of Food on Nerandomilast
Researchers are also studying whether taking Nerandomilast with or without food affects how the body absorbs and processes the medication. A specific trial is comparing different formulations of Nerandomilast tablets when taken with and without food. This information will help determine the best instructions for patients on when to take the medication in relation to meals.
How Effectiveness is Measured
In the clinical trials, researchers are measuring the effectiveness of Nerandomilast in several ways:
- Quantitative Interstitial Lung Disease (QILD) score: Measures the extent of lung fibrosis using high-resolution computed tomography (HRCT) scans. This includes measuring: A reduction in these scores would indicate improvement.
- Quantitative Lung Fibrosis (QLF): A measure of reticulation with architectural distortion in the lungs
- Quantitative Ground Glass Opacity (QGGO): A measure of hazy or cloudy areas within the lung
- Forced Vital Capacity (FVC): A lung function test that measures the amount of air that can be forcibly exhaled after taking a deep breath. Improvements or stabilization in FVC would suggest the medication is helping.
- Patient-reported outcomes: Using questionnaires like the Living with Pulmonary Fibrosis (L-PF) to assess symptoms such as: Lower scores would indicate symptom improvement.
- Dyspnea (shortness of breath)
- Cough
- Fatigue
- Quality of life
- Safety assessments: Monitoring for adverse events, including infection-related adverse events.
For the scleroderma-specific study, researchers are also looking at the revised CRISS score (Composite Response Index in Systemic Sclerosis) to evaluate overall improvement in participants with diffuse cutaneous systemic sclerosis.