RecruitingInterventionalPhase 3Updated May 28, 2026
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies | NCT07789015 | Trialant
Not yet recruitingInterventionalPhase 3Updated Aug 27, 2026
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
A Phase III, Parallel Design, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial to Evaluate the Efficacy and Safety of Nerandomilast Oral Therapy Added to Standard Background Therapy Over 52 Weeks in Adult Trial Participants With Active Idiopathic Inflammatory Myopathies (VERANDAâ„¢-IIM)
ClinicalTrials.gov ID
NCT07789015
Lead Sponsor
Boehringer IngelheimINDUSTRY
Overall Status
Not yet recruiting
Study Type
Interventional
Phase
Phase 3
Enrollment
270Estimated
Last Update Posted
Aug 27, 2026Actual
Start Date
Nov 9, 2026Estimated
Primary Completion Date
Mar 21, 2030Estimated
Completion Date
Mar 26, 2030Estimated
Official Title
A Phase III, Parallel Design, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial to Evaluate the Efficacy and Safety of Nerandomilast Oral Therapy Added to Standard Background Therapy Over 52 Weeks in Adult Trial Participants With Active Idiopathic Inflammatory Myopathies (VERANDAâ„¢-IIM)
Brief Summary
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.
Idiopathic Inflammatory Myopathies
Placebo
Nerandomilast
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male or female adult individuals from ≥18 years of age (or alternative age for adults based on local regulations) on the date of signing the informed consent.
A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 American college of rheumatology (ACR)/European alliance of associations of rheumatology (EULAR) classification criteria.
Participants with overlap myositis (OM) must have IIM as the predominant disease.
Participants ≥18 years of age (or alternative age for adults based on local regulations) with juvenile dermatomyositis (JDM) can only be included if they 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
Physician global activity (PhGA) derived from myositis disease activity assessment tool (MDAAT) ≥2 cm
Extramuscular disease activity as per MDAAT ≥2 cm
At least 1 muscle enzyme (aldolase, creatine kinase (CK), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or lactate dehydrogenase (LDH)) ≥1.5× upper limit of normal (ULN),
Health assessment questionnaire-disability index (HAQ-DI) ≥0.25.
For participants diagnosed with anti-synthetase syndrome (ASyS)* and OM*:
Active disease based on at least 1 of the following criteria:
CK ≥4× ULN at screening
Muscle biopsy indicative of active IIM within up to 6 months prior to screening
Evidence of active myositis by electromyography (EMG) within up to 6 months prior to screening
Magnetic resonance imaging with evidence of active myositis within up to 6 months prior to screening AND
Minimum disease activity defined by moderate to severe myopathy with MMT-8 of ≥ 80 and ≤142/150 at screening and baseline and at least 2 of the following CSM abnormalities at screening:
PtGA ≥2 cm
PhGA derived from MDAAT ≥2 cm
Extramuscular disease activity as per MDAAT ≥2 cm
At least 1 muscle enzyme ≥1.5× ULN
HAQ-DI ≥0.25. * Note: Inclusion Criteria #6a and #6b must be reviewed by the central eligibility committee.
The participant must be on background therapy for IIM. The standard treatments that are allowed as background therapy for IIM include:
Oral corticosteroid (OCS) monotherapy in doses ≤20 mg prednisone (or prednisone equivalent), OR
One of the following immunosuppressants/immunomodulators: azathioprine, mycophenolate mofetil or mycophenolic acid, methotrexate, 6 mercaptopurine, sulfasalazine, leflunomide, mizoribine, cyclosporine, tacrolimus in doses as per local guidelines (combinations of these treatments are not allowed), OR
One of the following antimalarials: hydroxychloroquine quinacrine, chloroquine, OR
Any combination of OCS in doses ≤20 mg prednisone (or prednisone equivalent), 1 of the above immunosuppressants/immunomodulators, and/or 1 of the above antimalarials
If using OCS for IIM, the participant must be introduced ≥4 weeks prior to screening. the dose must be stable and not exceed 20 mg/day of prednisone (or equivalent) 2 weeks prior to screening
If using immunosuppressants/immunomodulators and/or antimalarials the participant must have been on the same medication for ≥12 weeks before randomisation and on a stable dose for ≥4 weeks prior to randomisation
Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control for a period of 28 days before treatment initiation, throughout the trial, and for a period of at least 5 days after the last dose of investigational medicinal product (IMP). WOCBP taking oral contraceptives also have to use one barrier method.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Exclusion criteria:
Major surgery (major according to the investigator's assessment, e.g. hip replacement) performed within 6 weeks prior to randomisation or planned during the trial period.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Participants with uncontrolled IIM manifestations that, in the opinion of the investigator, would be likely to require treatment with restricted medications (e.g. cyclophosphamide) during the trial.
Participants diagnosed with advanced interstitial lung disease (ILD), with:
Forced vital capacity (FVC) <70% of predicted at screening OR
A history of any of the following up to 12 months prior to screening:
Diffusing capacity of the lung for carbon monoxide (DLCO) <70% of predicted
Hypoxemia requiring supplemental oxygen therapy, not attributable to sleep apnoea OR
Recent ILD exacerbation or respiratory hospitalisation related to ILD within the last 3 months.
Participants with Immune-mediated necrotizing myositis (IMNM); Inclusion body myositis (IBM), cancer-associated polymyositis (PM) or DM, and non-inflammatory myopathies (e.g. muscular dystrophies), antibody-negative PM, or amyopathic dermatomyositis (ADM) with a CDASI-A score ≤14.
Participants who experience improvement in MMT-8 (>10%) or PhGA (≥2 cm) from screening (Visit 1) to randomisation (Visit 2).
Severe muscle damage defined as a global muscle damage score of >5 on a 10-centimetre visual analogue scale (VAS) scale on the myositis damage Index (MDI).