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

Conditions

• Idiopathic Pulmonary Fibrosis
• Progressive Pulmonary Fibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nerandomilast — DRUG
  Nerandomilast

Study Details

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.

Key Dates

First listed

Feb 2, 2024

Start date

May 6, 2024

Status verified

Jul 2026

Primary completion

Apr 28, 2027

Completion

May 5, 2027

Study Design

Enrollment

1,700 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BI 1015550 treatment group

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

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (58)

Find similar trials in Birmingham, AL

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