A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies (VERANDA™-IIM)

September 2, 2026 updated by: Boehringer Ingelheim

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 (VERANDA™-IIM)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • C.a.b.a, Argentina, C1426BOD
      • CABA, Argentina, C1405BFN
      • CABA, Argentina, C1113
        • Centro Argentino de Investigacion (CADI)-Diagnostico Medico
        • Contact:
      • Capital Federal, Argentina, C1405BCH
      • La Plata, Argentina, B1902COS
      • Quilmes, Argentina, B1878DVB
      • Rosario, Argentina, S2000ORE
      • San Miguel de Tucumán, Argentina, 4000
      • Villa Nueva, Argentina, M5526DRW
  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
    • Victoria
      • Ivanhoe, Victoria, Australia, 3079
  • Belgium
      • Jette, Belgium, 1090
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
  • Brazil
      • Juiz de Fora, Brazil, 36010-570
      • Porto Alegre - RS, Brazil, CEP 90020-090
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Contact:
      • Salvador, Brazil, 40221-500
      • São Paulo, Brazil, 01246-903
        • Hospital das Clínicas da Faculdade de Medicina da USP
        • Contact:
      • Valinhos, Brazil, 13271-130
        • Azidus Centro de Pesquisa Clinica Avancada
        • Contact:
  • Bulgaria
      • Haskovo, Bulgaria, 6304
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1612
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • Quebec
      • Sherbrooke, Quebec, Canada, J1E 0N8
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
      • Chongqing, China, 400010
        • Second Affiliated Hospital Chongqing Medical University
        • Contact:
      • Dongguan, China, 523059
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Hefei, China, 230001
      • Luoyang, China, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanchang, China, 330038
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Nanjing, China, 210008
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China, 201112
        • Renji Hospital Shanghai Jiaotong University school of medicine
        • Contact:
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Xi'an, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
  • France
      • Angers, France, 49933
      • Bordeaux, France, 33076
      • Caen, France, 14000
      • Lyon, France, 69437
      • Paris, France, 75010
      • Paris, France, 75013
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
  • Germany
      • Bad Bramstedt, Germany, 24576
      • Berlin, Germany, 13125
      • Cologne, Germany, 51149
      • Erlangen, Germany, 91054
      • Freiburg im Breisgau, Germany, 79106
      • Halle, Germany, 06120
      • Kirchheim unter Teck, Germany, 73230
      • Tübingen, Germany, 72076
      • Ulm, Germany, 89081
  • Greece
      • Thessaloniki, Greece, 546 42
        • General Hospital of Thessaloniki "Ippokrateio"
        • Contact:
  • Hungary
  • Italy
      • Bari, Italy, 70124
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contact:
      • Catania, Italy, 95121
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Contact:
      • Padova, Italy, 35100
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
      • Torino, Italy, 10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
      • Kanagawa, Kawasaki, Japan, 216-8511
      • Kanagawa, Yokohama, Japan, 236-0004
      • Kyoto, Kyoto, Japan, 606-8507
      • Miyagi, Sendai, Japan, 983-8512
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contact:
      • Nara, Kashihara, Japan, 634-8522
      • Okayama, Okayama, Japan, 700-8558
      • Osaka, Suita, Japan, 565-0871
      • Tokyo, Bunkyo-ku, Japan, 113-8431
      • Tokyo, Bunkyo-ku, Japan, 113-8603
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Institute of Science Tokyo Hospital
        • Contact:
      • Tokyo, Ota-ku, Japan, 143-8541
        • Toho University Omori Medical Center
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-0023
      • Tokyo, Shinjuku-ku, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • Contact:
      • Guadalajara, Mexico, 44670
        • Panamerican Clinical Research Mexico
        • Contact:
      • Guadalajara, Mexico, 44160
        • Centro Integral en Reumatologia, SA. de CV.
        • Contact:
      • León, Mexico, 37000
      • Mexico City, Mexico, 14080
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
      • Mexico City, Mexico, 06700
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
        • Contact:
      • Mérida, Mexico, 97070
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
  • Poland
      • Bialystok, Poland, 15-707
        • Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fizjoterapeuty
        • Contact:
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
        • Contact:
      • Katowice, Poland, 40635
        • Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
        • Contact:
  • Portugal
      • Aveiro, Portugal, 3814-501
      • Coimbra, Portugal, 3004-561
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1649-035
  • Romania
      • Bucharest, Romania, 020475
      • Bucharest, Romania, 020983
        • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
        • Contact:
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de urgenta Cluj
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
      • Belgrade, Serbia, 11040
      • Kragujevac, Serbia, 34000
        • University Clinical Center of Kragujevac
        • Contact:
  • South Korea
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
        • Contact:
      • Seoul, South Korea, 03080
      • Seoul, South Korea, 02447
      • Seoul, South Korea, 04763
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
        • Contact:
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
        • Contact:
      • Valencia, Spain, 46017
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 40705
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 11217
  • Thailand
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakom Chiangmai Hospital
        • Contact:
      • Hat Yai, Thailand, 90110
      • Ratchathewi, Thailand, 10400
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
      • Scottsdale, Arizona, United States, 85259
    • California
      • Irvine, California, United States, 92697
      • Los Angeles, California, United States, 90095
      • San Francisco, California, United States, 94115
    • Florida
      • Orlando, Florida, United States, 32819
    • Kansas
      • Fairway, Kansas, United States, 66205
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5314
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St Louis, Missouri, United States, 63110
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Middleburg Heights, Ohio, United States, 44130
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Jackson, Tennessee, United States, 38305
    • Texas
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. 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.
  2. 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.
  3. Participants with overlap myositis (OM) must have IIM as the predominant disease.
  4. 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.
  5. Disease activity defined by moderate to severe myopathy.
  6. The participant must be on background therapy for IIM.
  7. 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.
  8. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  9. Further inclusion criteria apply.

Exclusion criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Participants diagnosed with advanced interstitial lung disease (ILD).
  5. Severe muscle damage.
  6. Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerandomilast
Drug: Nerandomilast
Nerandomilast
Placebo Comparator: Placebo
Placebo matching nerandomilast
Drug: Placebo
Placebo-matching nerandomilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total improvement score (TIS) score (continuous) at Week 52
Time Frame: At Week 52.
The TIS composite score includes 6 core set measures: manual muscle testing (MMT8), extra-muscular disease activity (MDAAT), patient global disease activity (PtGA), physician global disease activity (PhGA), health assessment questionnaire disability index (HAQ-DI), and muscle enzymes. An improvement score for each core set measure will be assigned using the absolute percent change, based on predetermined ranges. The TIS will be the sum of the all core set measure, scoring from 0 to 100, with higher scores corresponding to a greater degree of improvement.
At Week 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of a TIS-40 response (yes/no; defined as TIS ≥40) at Week 52
Time Frame: At Week 52.
Number of participants with 40 TIS points or higher.
At Week 52.
Achievement of a successful tapering of oral corticosteroids (OCS) (yes/no) at Week 52
Time Frame: At Week 52.
Number of participants achieving a TIS-40 response at Week 52 and ≤5 mg/day of prednisone (or equivalent) at Week 52
At Week 52.
Change from baseline in cutaneous dermatomyositis disease area and severity index activity score (CDASI-A) at Week 52 (in participants with baseline CDASI-A ≥6)
Time Frame: At baseline and at Week 52.
The Cutaneous Dermatomyositis Disease Area and Severity Index activity score (CDASI-A) is a questionnaire assessing skin disease activity and damage in patients with dermatomyositis (DM). It ranges from 0 to 100, with higher values indicating more severe active skin involvement.
At baseline and at Week 52.
Change from baseline in extra-muscular disease activity as per myositis disease activity assessment tool (MDAAT) at Week 52
Time Frame: At baseline and at Week 52.
Myositis Disease Activity Assessment Tool (MDAAT) is a questionnaire assessing the disease activity of extra-muscular organ systems and muscle in participants with IIM. It is a combined tool with two parallel scores: the MYOACT VAS and the MITAX. The Myositis disease activity assessment (MYOACT) visual analogue scale (VAS) scores the overall severity of disease activity. The sum of the individual scores ranges from 0 to 70, The higher the more severe. For the Myositis Intention-to-Treat Activity Index (MITAX), each question is answered with either: 0 = not present; 1 = improving; 2 = the same; 3 = worse; 4 = new. The summed scores are summed to obtain a total MITAX score with a range of 0 to 63, the higher the more severe.
At baseline and at Week 52.
Change from baseline in PtGA at Week 52
Time Frame: At baseline and at Week 52.
Patient global disease activity (PtGA) measures the participant's self-assessment of the disease. It is composed of a 100 mm visual analogue scale. Patients will mark their assessment between "extremely poor" (0) and "excellent" (100). The difference between 0 (extremely poor) and the patient assessment is the PtGA, where higher distances indicate a better health status.
At baseline and at Week 52.
Change from baseline in PhGA at Week 52
Time Frame: At baseline and at Week 52.
Physician global activity (PhGA) captures the physician's assessment of the participant's overall health. It is composed of a 100 mm visual analogue scale. Physicians will mark their assessment between "extremely poor" (0) and "excellent" (100). The difference between 0 (extremely poor) and the physician assessment is the PhGA, where higher distances indicate a better health status.
At baseline and at Week 52.
Change from baseline in HAQ-DI at Week 52
Time Frame: At baseline and at Week 52.
The health assessment questionnaire disability index (HAQ-DI) assesses difficulties in performing activities of daily living across 8 domains. Each domain is rated on a scale of 0-3. The higher the score, the higher the disability.
At baseline and at Week 52.
Change from baseline in MMT-8 score at Week 52
Time Frame: At baseline and at Week 52.
Manual Muscle Testing (MMT-8) assesses the muscle strength of 8 proximal, distal, and axial muscle groups. Each item is rated from 0 to 10, with the total score ranging from 0 to 150, where higher scores mean better muscle strength condition.
At baseline and at Week 52.
Achievement of a TIS-60 response (yes/no; defined as TIS ≥60) at Week 52
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Change from baseline in the most abnormal baseline muscle enzymes (aldolase, CK, AST, ALT, or LDH) at Week 52
Time Frame: At baseline and at Week 52.
CK means creatine kinase, AST means aspartate aminotransferase, ALT means alanine aminotransferase, and LDH means lactate dehydrogenase.
At baseline and at Week 52.
Change from baseline in clinical-reported outcome 1 at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.
Change from baseline in clinical-reported outcome 2 at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 9, 2026

Primary Completion (Estimated)

March 21, 2030

Study Completion (Estimated)

March 26, 2030

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0146
  • U1111-1338-2454 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-526365-24-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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