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Study identifier: NCT07497087 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

Condition: Systemic Sclerosis  ·  Sponsor: Boehringer Ingelheim

PhasePhase 3
Planned participants448
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis. 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 the tablets twice a day. Participants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-0127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (241)

University of Alabama at BirminghamBirmingham, Alabama, United StatesNot Yet Recruiting
Banner - University Medicine Rheumatology ClinicPhoenix, Arizona, United StatesNot Yet Recruiting
Arizona Arthritis and Rheumatology Associates - Paradise ValleyScottsdale, Arizona, United StatesNot Yet Recruiting
University of California Los AngelesLos Angeles, California, United StatesNot Yet Recruiting
Paradigm Clinical Research - San DiegoSan Diego, California, United StatesRecruiting
Stanford University School of MedicineStanford, California, United StatesNot Yet Recruiting
Medvin Clinical Research-Whittier-69033Whittier, California, United StatesRecruiting
University of Colorado DenverAurora, Colorado, United StatesNot Yet Recruiting
Georgetown UniversityWashington D.C., District of Columbia, United StatesNot Yet Recruiting
Millennium Research - Ormond BeachOrmond Beach, Florida, United StatesNot Yet Recruiting
Integral Rheumatology and Immunology SpecialistPlantation, Florida, United StatesNot Yet Recruiting
BioResearch Partner - South MiamiSouth Miami, Florida, United StatesRecruiting

+ 229 more locations — full list on the registry record.

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