Clinical trials: sponsored by Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood
The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.
- Trial name
- NCT06028464
- Testing
- Zongertinib, Carbamazepine
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market.
- Trial name
- NCT05380947
- Testing
- BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), Rabeprazole sodium
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Lung Diseases, Interstitial
INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
The primary objective of this study is to investigate the correlation between changes from baseline to 52 weeks in Forced Vital Capacity (FVC) [% pred.] and changes from baseline to 52 weeks in dyspnea score [points] or cough…
- Trial name
- NCT05151640
- Testing
- Nintedanib
- Where
- 31 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim
Generalized Pustular Psoriasis
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study.
- Trial name
- NCT04399837
- Testing
- Spesolimab
- Where
- 72 sites in United States, Argentina and 21 more
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
Palmoplantar Pustulosis
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab.
- Trial name
- NCT04493424
- Testing
- Spesolimab
- Where
- 66 sites in United States, Australia and 12 more
- Volunteers
- 108 people
- Sponsor
- Boehringer Ingelheim
Generalized Pustular Psoriasis
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.
- Trial name
- NCT05670821
- Testing
- Spesolimab
- Where
- Japan
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body
The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous…
- Trial name
- NCT03617835
- Testing
- R - Low dose of BI 655130, T1 - Low dose of BI 655130, T2 - Low dose of BI 655130
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hidradenitis Suppurativa
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe…
- Trial name
- NCT04762277
- Testing
- Spesolimab - solution for infusion, Spesolimab- solution for injection
- Where
- 25 sites in United States, Australia and 10 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Generalized Pustular Psoriasis
An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
This Expanded Access Program in China is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP).
- Trial name
- NCT05239039
- Testing
- spesolimab
- Where
- 12 sites in China
- Volunteers
- 39 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older.
- Trial name
- NCT05321069
- Testing
- BI 1015550
- Where
- 334 sites in United States, Argentina and 35 more
- Volunteers
- 1,177 people
- Sponsor
- Boehringer Ingelheim
Dermatitis, Atopic
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.
- Trial name
- NCT03822832
- Testing
- BI 655130
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130…
- Trial name
- NCT03648541
- Testing
- Spesolimab
- Where
- 38 sites in United States, Austria and 10 more
- Volunteers
- 79 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite…
- Trial name
- NCT03123120
- Testing
- Spesolimab
- Where
- 16 sites in Denmark, Germany and 4 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Lupus Nephritis
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the…
- Trial name
- NCT02770170
- Testing
- BI 655064 dose 1, BI 655064 dose 2, BI 655064 dose 3
- Where
- 74 sites in United States, Australia and 18 more
- Volunteers
- 121 people
- Sponsor
- Boehringer Ingelheim
Crohn Disease
A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
This is a study in adults with Crohn's Disease who also have fistulas near the anus. The study has 2 parts. The first part is to find out more about what causes the fistulas.
- Trial name
- NCT03752970
- Testing
- Spesolimab
- Where
- 10 sites in Austria, Belgium and 6 more
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
Palmoplantar Pustulosis (PPP)
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16.
- Trial name
- NCT04015518
- Testing
- Spesolimab
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 152 people
- Sponsor
- Boehringer Ingelheim
Psoriasis
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
- Trial name
- NCT03135548
- Testing
- Spesolimab (low dose), Spesolimab (high dose)
- Where
- 18 sites in Canada, Denmark and 4 more
- Volunteers
- 59 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active…
- Trial name
- NCT03482635
- Testing
- Spesolimab
- Where
- 54 sites in United States, Austria and 10 more
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects
The primary objective of this trial is to investigate the relative bioavailability of BI 655130 following subcutaneous administration (Test, T) compared to BI 655130 following intravenous infusion (Reference, R).
- Trial name
- NCT03100903
- Testing
- BI 655130
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Generalized Pustular Psoriasis
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
- Trial name
- NCT03782792
- Testing
- Spesolimab
- Where
- 37 sites in United States, China and 10 more
- Volunteers
- 53 people
- Sponsor
- Boehringer Ingelheim
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