Long-term treatment with nerandomilast for pulmonary fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on individuals with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously participated in trials involving nerandomilast. The primary aim is to evaluate the long-term tolerance of nerandomilast and its effectiveness in improving lung function and delaying the progression of symptoms. Participants will take nerandomilast tablets for up to 1 year and 10 months while continuing their regular pulmonary fibrosis treatments. Regular doctor visits will be conducted to monitor health and perform lung function tests.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• University of California Davis
  Sacramento, California, United States Recruiting

+323 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

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• Registry for individuals affected by pulmonary fibrosis

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• Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

  This study tests whether nerandomilast helps slow lung function decline in adults with IPF or progressive fibrotic lung disease in routine clinical care.

  Recruiting at 4 sites Tel Aviv Medical Center · Ashkelon and 3 other locations · NCT07919015

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• Treprostinil Palmitil Inhalation Powder for Progressive Pulmonary Fibrosis

  A 52-week study will test whether once-daily Treprostinil Palmitil Inhalation Powder helps lung function in adults with progressive pulmonary fibrosis compared to placebo.

  Recruiting Phase 3 Insmed Incorporated · DuBois, Pennsylvania · NCT07805785

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.