Nerandomilast for Pulmonary Fibrosis

Not yet recruiting at 49 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must not be taking: Nerandomilast, Nintedanib, Pirfenidone

Disqualifiers: Pulmonary fibrosis, Connective tissue disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 104-156 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether nerandomilast can slow lung scarring in individuals with a family history of pulmonary fibrosis, a condition where lung tissue becomes scarred, making breathing difficult. Participants will randomly receive either nerandomilast or a placebo, which resembles the medicine but contains no active ingredients. The trial spans 2 to 3 years and includes regular check-ups and lung tests to assess nerandomilast's effectiveness. Suitable candidates have a relative with pulmonary fibrosis and show early lung changes on a scan. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that nerandomilast is likely to be safe for humans?

Research has shown that nerandomilast is generally well-tolerated. In earlier studies with patients who have idiopathic pulmonary fibrosis (IPF), side effects were manageable. While some participants experienced unwanted effects, these were not severe enough to halt treatment. The data indicated that the treatment reduced the risk of death in patients with lung conditions similar to pulmonary fibrosis. Although these results are promising, it is important to note that the safety and effectiveness of nerandomilast have not been studied in children. The drug is typically used for older adults with lung problems. This trial will closely monitor participants to ensure safety and assess how well the treatment works over time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nerandomilast is unique because, unlike current treatments for pulmonary fibrosis like antifibrotic drugs (such as pirfenidone and nintedanib), it works by targeting specific inflammatory pathways involved in the disease. Researchers are excited about Nerandomilast because it introduces a novel approach by potentially reducing lung inflammation more effectively, which could slow down disease progression. This innovative mechanism of action sets it apart from existing therapies, offering hope for improved outcomes for patients with this challenging condition.

What evidence suggests that nerandomilast might be an effective treatment for pulmonary fibrosis?

Studies have shown that nerandomilast, which participants in this trial may receive, can slow the decline in lung function for people with pulmonary fibrosis. In patients with idiopathic pulmonary fibrosis, those taking nerandomilast experienced a smaller decrease in lung capacity compared to those on a placebo over a year. Research also suggests that nerandomilast may lower the risk of death in people with pulmonary fibrosis. It blocks an enzyme called PDE4B, which contributes to inflammation—a key factor in lung damage. The evidence supports that nerandomilast can effectively slow the progression of lung scarring in pulmonary fibrosis. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people aged 40+ with a family history of pulmonary fibrosis and early lung changes on scans. It's not suitable for those without these specific lung abnormalities or other conditions that might interfere with the study.

Inclusion Criteria

Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b

Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b

I am 40 years old or older.

Exclusion Criteria

Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1b

HRCT findings consistent with probable or definite UIP pattern

I have been treated for pulmonary fibrosis before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take nerandomilast or placebo tablets twice a day to assess the efficacy in slowing lung changes

104-156 weeks

Every 3 months for the first 2 years, then every 6 months; phone calls every 3 months in the 3rd year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerandomilast
• Placebo

Trial Overview The study tests if nerandomilast can slow down lung tissue scarring in at-risk individuals. Participants are randomly assigned to receive either nerandomilast or a placebo, taken twice daily for up to three years, with regular health checks.

How Is the Trial Designed?

Group I: Nerandomilast Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2414108

Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis In patients with idiopathic pulmonary fibrosis, treatment with nerandomilast resulted in a smaller decline in the FVC than placebo over a period of 52 weeks.

2. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/nerandomilast-monotherapy-ipf-ppf-death-reduction

Nerandomilast monotherapy IPF PPF death reduction Pooled data presented at ERS: nerandomilast monotherapy linked to nominally significant reduction in risk of death in IPF and PPF.

3. pulmonaryfibrosis.org pulmonaryfibrosis.org/about-us/news-and-media/news/article/2025/10/07/fda-approves-nerandomilast-(jascayd)-for-idiopathic-pulmonary-fibrosis

FDA approves Nerandomilast (Jascayd) for Idiopathic ... Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, demonstrated statistically significant efficacy in slowing the rate of lung ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40388329/

Nerandomilast in Patients with Progressive Pulmonary ... Conclusions: In patients with progressive pulmonary fibrosis, treatment with nerandomilast led to a smaller decline in the FVC than placebo ...

5. medcentral.com medcentral.com/pulmonology/new-data-add-support-for-nerandomilast-in-ipf-treatment

New Data Add Support for Nerandomilast in IPF Treatment Among all patients, the adjusted mean change in FVC at week 52 was -183.5 with placebo, -138.6 with nerandomilast 9 mg, and -114.7 with ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/218764s000lbl.pdf

JASCAYD® (nerandomilast tablets), for oral use The safety and effectiveness of JASCAYD for the treatment of idiopathic pulmonary fibrosis have not been established in pediatric patients. 8.5 Geriatric Use.