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

NCT06806592 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Nerandomilast

Nerandomilast

DRUG

Placebo matching nerandomilast

Placebo matching nerandomilast

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-13
Primary Completion
2027-07-17
Completion
2027-07-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Puerto Rico
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06806592 on ClinicalTrials.gov