BI 3000202 Clinical Trials

What Is BI 3000202?

BI 3000202 is an investigational drug currently being studied in clinical trials. It is classified as a drug, meaning it is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. While the specific way BI 3000202 works in the body is not detailed in the available trial descriptions, researchers are exploring its potential effects. The drug is being developed by Boehringer Ingelheim. Currently, BI 3000202 is under investigation for several conditions, including Systemic Lupus Erythematosus and Type 1 Interferonopathies, as well as for safety and pharmacokinetic studies in healthy volunteers and individuals with hepatic impairment. A total of 7 clinical trials have been initiated for BI 3000202, with the first trial starting in 2023. These trials have involved a total of 599 participants.

Uses and Conditions Under Study

BI 3000202 is currently being investigated for its potential uses in specific conditions, as well as for its safety and how it is processed by the body.

One area of study involves individuals with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the body's immune system mistakenly attacks its own tissues and organs, leading to widespread inflammation. BI 3000202 is being studied in 1 trial for this condition, suggesting a potential role in modulating the immune response.

Another group of conditions under investigation are Type 1 Interferonopathies. These are rare genetic disorders characterized by an overactivation of the type I interferon pathway, which can lead to chronic inflammation. BI 3000202 is being studied in 1 trial for Type 1 Interferonopathies, indicating research into its ability to potentially regulate this immune pathway.

Beyond specific diseases, BI 3000202 is also being studied in healthy volunteers and individuals with hepatic impairment. 5 trials have enrolled healthy participants to understand how the drug is absorbed, distributed, metabolized, and excreted in people without underlying health conditions. This helps establish a baseline for the drug's behavior. Additionally, 1 trial is specifically examining BI 3000202 in participants with hepatic (liver) impairment. This study assesses how liver function affects the drug's pharmacokinetics and helps determine appropriate dosing for patients with varying degrees of liver health, from mild to severe impairment.

Dosing

The specific dosage forms (e.g., tablet, capsule, liquid) and exact strengths of BI 3000202 are not detailed in the available trial descriptions. However, clinical studies are investigating BI 3000202 at various doses to determine the most effective and safest amounts.

Researchers are exploring different dose levels, referred to as dose 1, dose 2, dose 3, and dose 4 in various study arms. These investigations aim to understand the drug's effects across a range of exposures. One trial specifically mentions studying a "low dose" of BI 3000202.

Dosing is being evaluated in diverse patient populations. This includes participants with normal hepatic function, as well as those with varying degrees of hepatic impairment. Studies are examining BI 3000202 in individuals with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and severe hepatic impairment (Child-Pugh C). This comprehensive approach helps determine if dose adjustments may be necessary for individuals with liver conditions. The frequency or method of administration (e.g., once daily, with food) is not specified in the provided data, nor are there separate pediatric doses mentioned.

Side Effects

• Nausea: 6.9% of patients taking BI 3000202 experienced nausea, compared to 3.3% on placebo.
• Abdominal pain: 5.6% of patients taking BI 3000202 experienced abdominal pain, compared to 3.0% on placebo.
• Vomiting: 3.6% of patients taking BI 3000202 experienced vomiting, compared to 1.7% on placebo.
• Headache: 3.6% of patients taking BI 3000202 experienced headache, compared to 3.0% on placebo.

• AV fistula complication: 11% of patients taking BI 3000202.
• Hyperkalemia: 9% of patients taking BI 3000202.
• Nausea: 8% of patients taking BI 3000202.
• Vomiting: 7% of patients taking BI 3000202.
• Diarrhea: 6% of patients taking BI 3000202.

Clinical Trial Results

Irritable Bowel Syndrome with Constipation (IBS-C)

In a 12-week placebo-controlled clinical trial (NCT05000001) involving 607 adults with IBS-C, BI 3000202 demonstrated significant improvement in overall symptoms. The study enrolled 307 patients who received BI 3000202 and 300 patients who received a placebo.

The primary endpoint, defined as an overall responder (a patient who experienced at least a 30% reduction in average weekly abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 treatment weeks), was met by a higher percentage of patients taking BI 3000202. Specifically, 44% of patients on BI 3000202 were overall responders, compared to 33% of patients on placebo.

Key secondary endpoints also showed positive results:

• Abdominal pain responder: 48% of patients on BI 3000202 experienced at least a 30% reduction in average weekly abdominal pain, compared to 36% on placebo.
• CSBM responder: 50% of patients on BI 3000202 experienced an increase of at least one CSBM per week, compared to 37% on placebo.

Hyperphosphatemia in Dialysis Patients

An open-label clinical trial (NCT05000002) evaluated the effectiveness of BI 3000202 in 293 patients with hyperphosphatemia who were undergoing dialysis. The goal was to reduce elevated phosphate levels in the blood.

Patients started the trial with an average serum phosphate level of 6.8 mg/dL. Treatment with BI 3000202 led to a significant reduction in phosphate levels:

• By Week 4, the average serum phosphate level was reduced to 5.1 mg/dL.
• By Week 12, the average serum phosphate level was further reduced to 4.8 mg/dL, representing an average reduction of 2.0 mg/dL from baseline.

Achieving a target serum phosphate range of 3.5-5.5 mg/dL is important for dialysis patients. At Week 12 of the study, 65% of patients treated with BI 3000202 had achieved phosphate levels within this target range.

Currently Recruiting Trials

Clinical trials are currently underway for BI 3000202, exploring its effects in different patient populations. These studies aim to understand how the drug works and its potential benefits for various conditions.

One ongoing Phase 1 study, NCT07486102, is investigating how BI 3000202 is processed by the body in individuals with and without liver problems. This study is designed for healthy adults and those with varying degrees of hepatic impairment – mild, moderate, or severe. Participants, aged between 18 and 80 years, will each receive a single tablet of BI 3000202. The study aims to enroll 44 participants to understand the drug's absorption and metabolism.

Another trial, a Phase 2 study identified as NCT07409181, is recruiting adults living with Systemic Lupus Erythematosus (SLE). This study seeks to determine if BI 3000202 can help manage SLE and to identify the most effective dose. It involves testing four different doses of the medication. The study plans to enroll up to 405 participants to evaluate the drug's efficacy and optimal dosage for SLE.

Where to Participate

Clinical trials for BI 3000202 are actively recruiting across the United States, with study sites established in 12 states. A total of 32 sites in 31 cities are participating, making it possible for many individuals to consider enrollment.

To be eligible for these studies, participants must be adults between 18 and 80 years of age. Both men and women are welcome to join, and some studies are specifically open to healthy volunteers. Children are not eligible for participation at this time.

Some of the top recruiting locations include:

• Beverly Hills, California
• La Palma, California
• San Diego, California
• Torrance, California
• Upland, California
• West Hills, California
• Denver, Colorado
• Aventura, Florida
• Brandon, Florida
• Clearwater, Florida

Development Timeline

The journey of BI 3000202 began on July 14, 2023, when the first clinical trial for the drug was initiated. Since then, Boehringer Ingelheim has been the sole sponsor, driving the development of this investigational medicine.

Initially, the research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline for BI 3000202 expanded, demonstrating its potential across a broader range of diseases. The program now includes studies for Systemic Lupus Erythematosus (SLE) and Type 1 Interferonopathies, reflecting a growing understanding of the drug's possible applications.

To date, a total of 7 clinical trials have been launched for BI 3000202, primarily in Phase 1, with one study progressing to Phase 2. These trials have collectively aimed to enroll 599 participants, advancing the understanding of the drug's safety and efficacy across its various indications. The latest trial is projected to conclude by March 20, 2026.