Recruiting
Phase 3

Nerandomilast

Sponsor:

Boehringer Ingelheim

Code:

NCT06238622

Conditions

Idiopathic Pulmonary Fibrosis

Progressive Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nerandomilast

Study Details

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Progressive Pulmonary Fibrosis

Study ID

NCT06238622

Start date

May 6, 2024

Status verified date

Aug, 2026

Completion date

May 5, 2027

Anticipated

Primary completion date

Apr 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BI 1015550 treatment group

Interventions

Nerandomilast

Nerandomilast

Primary outcome measure

  • Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99 [ Time Frame: Up to 99 weeks and 3 days ]

Central Contacts and Locations

Central contacts

Locations

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Creighton University

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Northern Westchester Hospital

Recruiting

Mount Kisco, New York, United States, 10549

Contacts

Clinical Trials Center of Middle Tennessee, LLC

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Renovatio Clinical-The Woodlands-69551

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

University of Alberta Hospital (University of Alberta)

Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contacts

Kelowna Respirology & Allergy Research

Recruiting

Kelowna, British Columbia, Canada, V1Y 3H5

Contacts

St. Paul's Hospital (Vancouver)

Recruiting

Vancouver, British Columbia, Canada, V1Y 1S1

Contacts

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Dr. Georges-L.-Dumont University Hospital Centre

Recruiting

Moncton, New Brunswick, Canada, E1C 2Z3

Contacts

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 1Y2

Contacts

Dr. Syed Anees Medicine Professional Corporation

Recruiting

Windsor, Ontario, Canada, N8X 1T3

Contacts

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

CIC Mauricie (Trois Rivieres)

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

Contacts

Royal University Hospital (Saskatoon)

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Recruiting

Québec, Canada, G1V 4G5

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-20.