A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Conditions

• Interstitial Lung Diseases
• Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nerandomilast — DRUG
  Nerandomilast
• Placebo matching nerandomilast — DRUG
  Placebo matching nerandomilast

Study Details

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Key Dates

Start date

Sep 13, 2025

Status verified

Jun 2026

Primary completion

Jul 17, 2027

Completion

Jul 30, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nerandomilast
  Participants with SARD-ILDs will receive nerandomilast.
• Placebo Comparator: Placebo
  Participants with SARD-ILDs will receive placebo.

Primary Outcome Measure

Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26 [ Time Frame: At baseline and at Week 26 ]

Central Contacts

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

Locations (33)

Find similar trials in Birmingham, AL

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