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Bi 1015550

BI 1015550, also known as Nerandomilast, is a drug currently being studied in various clinical trials. These trials aim to investigate its safety, tolerability, and how it’s processed in the body (pharmacokinetics) in different populations, including healthy volunteers and those with specific health conditions. The studies explore different dosages, formulations, and administration methods to better understand the drug’s potential therapeutic use.

Table of Contents

What is BI 1015550?

BI 1015550, also known as Nerandomilast, is an investigational drug being developed by Boehringer Ingelheim for the treatment of pulmonary fibrosis[1]. It is currently undergoing clinical trials to evaluate its safety and effectiveness in treating various forms of lung fibrosis, particularly idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).

What Conditions Does BI 1015550 Treat?

BI 1015550 is primarily being studied for the treatment of two main conditions:

  • Idiopathic Pulmonary Fibrosis (IPF): This is a chronic, progressive lung disease characterized by the formation of scar tissue in the lungs, making it difficult to breathe[2].
  • Progressive Pulmonary Fibrosis (PPF): This term encompasses various forms of progressive fibrotic lung diseases that share similarities with IPF[1].

Both of these conditions involve the gradual scarring of lung tissue, which can lead to breathing difficulties and reduced quality of life for patients.

How Does BI 1015550 Work?

While the exact mechanism of action is not fully described in the provided clinical trial information, BI 1015550 is being studied for its potential to slow down the worsening of lung function in patients with pulmonary fibrosis[2]. The drug is believed to have anti-fibrotic properties, which means it may help reduce the formation of scar tissue in the lungs.

Clinical Trials and Research

BI 1015550 is currently being evaluated in several clinical trials:

  • Phase 2 Trial: A 12-week study was conducted to test how BI 1015550 affects lung function in people with IPF. This trial compared the drug to a placebo and included patients who were already taking standard IPF medications like nintedanib or pirfenidone[2].
  • Phase 3 Trial: A longer-term study (at least 52 weeks) is ongoing to further evaluate the efficacy and safety of BI 1015550 in IPF patients. This trial is testing different doses of the drug against a placebo[3].
  • Extension Study: An open-label extension trial is being conducted to assess the long-term safety and efficacy of BI 1015550 in patients with IPF and PPF who have completed previous studies with the drug[1].

These trials are measuring various outcomes, including changes in lung function (measured by Forced Vital Capacity or FVC), time to disease progression, and quality of life measures.

How is BI 1015550 Administered?

BI 1015550 is taken orally in the form of tablets. In clinical trials, it has been administered in various ways:

  • Twice daily dosing (morning and evening)[2]
  • Different dosage strengths are being tested (e.g., low dose and high dose)[3]
  • Some trials have used a combination of tablet strengths (e.g., 1x 6mg tablet + 1x 12mg tablet) to achieve the desired daily dose[2]

The exact dosing regimen may vary depending on the specific trial and patient characteristics.

Potential Side Effects

As BI 1015550 is still in clinical trials, the full range of potential side effects is not yet known. However, the trials are closely monitoring for any adverse events (unwanted effects) that may occur during treatment[3]. Patients participating in these studies are regularly checked for any health issues that may arise.

Future Prospects

BI 1015550 shows promise as a potential new treatment option for patients with pulmonary fibrosis. If successful in clinical trials, it could offer an alternative or complementary therapy to existing treatments. The ongoing long-term studies will provide more information about its effectiveness and safety over extended periods[1].

It’s important to note that as an investigational drug, BI 1015550 is not yet approved for general use. Patients interested in this treatment should discuss current clinical trial opportunities with their healthcare providers.

Aspect Details
Drug Name BI 1015550 (Nerandomilast)
Study Types Safety, tolerability, pharmacokinetics
Populations Studied Healthy volunteers, individuals with renal impairment
Formulations Powder for oral solution, tablets
Key Measurements AUC, Cmax, adverse events
Special Considerations Food effects, different dosages, bioequivalence of formulations
Study Designs Single-dose, multiple-dose, crossover, parallel group

FAQ

  • What is BI 1015550? BI 1015550, also known as Nerandomilast, is an investigational drug being studied in clinical trials. It's being tested in various formulations, including powder for oral solution and tablets.
  • What are the main objectives of the clinical trials for BI 1015550? The main objectives include assessing the safety and tolerability of the drug, studying its pharmacokinetics (how the body processes the drug), and investigating the effects of food, different dosages, and various formulations on the drug's absorption and effectiveness.
  • Who can participate in these clinical trials? Most of the trials involve healthy volunteers, but some studies also include people with specific conditions, such as those with moderate to severe kidney problems. The eligibility criteria vary depending on the specific trial.
  • What are some of the outcomes being measured in these trials? Key outcomes include the area under the concentration-time curve (AUC) and maximum concentration (Cmax) of the drug in plasma, which help researchers understand how the drug is absorbed and processed by the body. Safety outcomes, such as the occurrence of adverse events, are also closely monitored.
  • How long do these clinical trials typically last? The duration varies depending on the specific trial design. Some studies involve single doses and last only a few days, while others involve multiple doses over several weeks. Follow-up periods for safety monitoring may extend the total study duration.

Ongoing Clinical Trials on Bi 1015550

  • A study to evaluate the effectiveness of BI 1015550 in people with lung abnormalities and a family history of pulmonary fibrosis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • Study of Amlitelimab and BI 1015550 for Patients with Interstitial Lung Disease Due to Scleroderma

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark France Germany Italy +5

  • Long-Term Study of BI 1015550 for Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark Estonia +14

  • Study on the Effects of Food on Two Formulations of Nerandomilast in Healthy Adults

    Not recruiting

    1 1
    Investigated drugs:
    Germany

  • Study on BI 1015550 for Improving Lung Function in Patients with Progressive Fibrosing Interstitial Lung Diseases

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark Estonia +13

Glossary

  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • AUC (Area Under the Curve): A measure of the total exposure to a drug over time, used to assess how much of the drug is absorbed by the body.
  • Cmax: The maximum concentration of a drug observed in the blood plasma after administration.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Bioequivalence: The absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of drug action when administered in the same dose under similar conditions.
  • Renal Impairment: A condition where the kidneys are not functioning at full capacity, which can affect how drugs are processed and eliminated from the body.
  • Formulation: The way a drug is prepared and presented for use, such as a tablet, capsule, or liquid solution.
  • Single-dose Study: A clinical trial where participants receive only one dose of the study drug to assess its immediate effects and how it's processed by the body.

References

  1. https://clinicaltrials.gov/study/NCT06238622
  2. https://clinicaltrials.gov/study/NCT04419506
  3. https://clinicaltrials.gov/study/NCT05321069