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A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

Study acronym: VERANDA™-SSc
StatusRecruiting
PhasePhase 3
Started2026-07-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v12
Trial sites expanded: 246 → 249 locations
2026-08-19
minor
Study Status, Contacts/Locations v11
Trial sites expanded: 242 → 246 locations
2026-08-05
minor
Study Status, Contacts/Locations v10
Study sites241→242
2026-07-29
notable
Study Status, Contacts/Locations, References v9
Recruitment opened
Trial sites expanded: 236 → 241 locations
Start dateestimated 2026-07-10→confirmed 2026-07-27
2026-07-07
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 233 → 236 locations
Start date2026-06-22→2026-07-10
Show 4 earlier versions
2026-06-23
minor
Study Status, Contacts/Locations v7
Study sites235→233
2026-06-09
minor
Study Status, Contacts/Locations v6
Start date2026-06-09→2026-06-22
Study sites233→235
2026-05-27
minor
Study Status, Contacts/Locations v5
Study sites232→233
2026-05-12
minor
Study Status, Contacts/Locations v4
Study sites230→232
2026-04-28
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 226 → 230 locations
2026-04-14
minor
Study Status, Contacts/Locations v2
Trial sites expanded: 211 → 226 locations
2026-04-01
minor
Study Status, Contacts/Locations v1
Trial sites expanded: 0 → 211 locations
2026-03-23
minor
Original filing
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.
Trial Details
NCT Number NCT07497087
Lead Sponsor Boehringer Ingelheim
Conditions Systemic Sclerosis
Enrollment 448 participants
Start Date 2026-07-27
Primary Completion 2030-02-26 (estimated)
Study Completion 2030-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-30