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A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies

Study acronym: VERANDA™-IIM
StatusNot Yet Recruiting
PhasePhase 3
Started2026-11-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Trial sites expanded: 141 → 147 locations
2026-09-02
Study Status, Contacts/Locations v2
Study sites140→141
2026-08-27
Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Study sites138→140
Eligibility criteria-3,829 characters
[...] y were 15 years old or older at first onset of DM symptoms. For participants diagnosed with DM Disease activity defined by moderate to severe myopathy with manual muscle testing-8 (MMT-8) of ≥80 and ≤142/150 and cutaneous dermatomyositis disease area and severity index activity score (CDASI-A) ≥6 at screening and baseline and at least 2 of the following core set measures (CSM) abnormalities at screening: Patient global assessment (PtGA) ≥2 cm Phy [...] . For participants diagnosed with anti-synthetase syndrome (ASyS)* and OM*: Active disease based on at least 1 of the following criteria: CK ≥4× ULN a [...] [...]
Secondary endpoints12 entries, revised
Change from baseline in CDASIclinical-Areported outcome 1 at Week 12 (in participants with baseline CDASI-A ≥6) Change from baseline in 5clinical-Dreported itchoutcome 2 at Week 12 (in participants with baseline CDASI-A ≥6)
2026-08-24
Original filing
This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms. 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 nerandomilast or placebo twice a day for 1 year. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.
Trial Details
NCT Number NCT07789015
Lead Sponsor Boehringer Ingelheim
Conditions Idiopathic Inflammatory Myopathies
Enrollment 270 participants
Start Date 2026-11-09
Primary Completion 2030-03-21 (estimated)
Study Completion 2030-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-30