NCT06238622 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
| NCT ID | NCT06238622 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Boehringer Ingelheim |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,700 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2027-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,700 participants in total. It began in 2024-05-06 with a primary completion date of 2027-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06238622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06238622 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,700 participants.
Is NCT06238622 currently recruiting?
Yes, NCT06238622 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT06238622 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06238622 clinical trial?
NCT06238622 is sponsored by Boehringer Ingelheim. The trial plans to enroll 1,700 participants.