🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06238622
Recruiting Phase 3

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622 · tracked via the Priya Life Science India tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2024-05-06
Last updated
2026-08-20

Condition(s) studied

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

Nerandomilast

Nerandomilast: Nerandomilast

Study summary

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.

The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.

Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.

Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption) 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control Exclusion Criteria: 1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion. 2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1: * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) 3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1. 4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1. 5. Patient will undergo lung transplantation, with an assigned date of surgery. 6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial 7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial 8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (373)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Active Not Recruiting
University of Arizona Tucson Arizona Active Not Recruiting
University of Southern California Los Angeles California Active Not Recruiting
Cedars-Sinai Medical Center Los Angeles California Active Not Recruiting
University of California Los Angeles Los Angeles California Active Not Recruiting
University of California Davis Sacramento California Recruiting
National Jewish Health Denver Colorado Active Not Recruiting
Yale University School of Medicine New Haven Connecticut Active Not Recruiting
Christiana Hospital Newark Delaware Completed
Georgetown University Washington D.C. District of Columbia Active Not Recruiting
St. Francis Medical Institute Clearwater Florida Completed
University of Florida Gainesville Florida Active Not Recruiting
Clinical Research Specialists LLC - Kissimmee Kissimmee Florida Active Not Recruiting
Advanced Pulmonary Research Institute Loxahatchee Groves Florida Active Not Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead Atlanta Georgia Active Not Recruiting
The Emory Clinic Atlanta Georgia Active Not Recruiting
Northshore University Health System Evanston Illinois Active Not Recruiting
University of Kansas Medical Center Kansas City Kansas Active Not Recruiting
Tulane Medical Center New Orleans Louisiana Active Not Recruiting
Johns Hopkins Hospital Baltimore Maryland Active Not Recruiting
Massachusetts General Hospital Boston Massachusetts Active Not Recruiting
Brigham and Women's Hospital Boston Massachusetts Active Not Recruiting
St. Elizabeth's Medical Center Boston Massachusetts Active Not Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Active Not Recruiting
University of Michigan Ann Arbor Michigan Active Not Recruiting
Corewell Health William Beaumont University Hospital Royal Oak Michigan Active Not Recruiting
University of Minnesota Minneapolis Minnesota Active Not Recruiting
Mayo Clinic, Rochester Rochester Minnesota Active Not Recruiting
The Lung Research Center, LLC Chesterfield Missouri Active Not Recruiting
Creighton University Omaha Nebraska Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Renown Regional Medical Center Reno Nevada Active Not Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Completed
Northern Westchester Hospital Mount Kisco New York Recruiting
Columbia University Medical Center-New York Presbyterian Hospital New York New York Active Not Recruiting
NewYork-Presbyterian/Weill Cornell Medical Center New York New York Active Not Recruiting
Duke University Medical Center Durham North Carolina Active Not Recruiting
Southeastern Research Center-Winston Salem-69289 Winston-Salem North Carolina Active Not Recruiting
University of Cincinnati Cincinnati Ohio Active Not Recruiting
Cleveland Clinic Cleveland Ohio Active Not Recruiting

+ 333 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06238622 on ClinicalTrials.gov ↗ ← All trials in India