A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (VERANDA™-SSc)

May 27, 2026 updated by: Boehringer Ingelheim

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

448

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
      • CABA, Argentina, C1128AAF
      • CABA, Argentina, C1405BFN
      • CABA, Argentina, 1015
      • Maipu, Argentina, M5515DQA
      • Quilmes, Argentina, B1878GEG
        • Instituto de Investigaciones Clínicas de Quilmes
        • Contact:
      • Rosario, Argentina, S2000ORE
  • Australia
    • New South Wales
      • Camperdown, Sydney, New South Wales, Australia, 2050
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
  • Austria
  • Belgium
  • Brazil
      • Curitiba, Brazil, 80810-000
        • SAPIENS - Instituto de Estudos e Pesquisa Clínica
        • Contact:
      • Porto Alegre, Brazil, 90035-074
        • Santa Casa de Misericordia de Porto Alegre
        • Contact:
      • Recife, Brazil, 50740900
        • Hospital das Clínicas da Universidade Federal de Pernambuco
        • Contact:
      • Salvador, Brazil, 40221-500
      • São Paulo, Brazil, 04038-002
        • Fundacao Oswaldo Ramos (Hospital do Rim)
        • Contact:
      • Valinhos, Brazil, 13271-130
        • Azidus Centro de Pesquisa Clinica Avancada
        • Contact:
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1431
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
      • Edmonton, Alberta, Canada, T6G 1Z1
        • University of Alberta Hospital (University of Alberta)
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care (London, Ontario)
        • Contact:
  • Chile
      • Comuna de Recoleta, Chile, 8420383
        • Centro Internacional de Estudios Clínicos (CIEC)
        • Contact:
      • Providencia, Chile, 7500571
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100034
        • Peking University First Hospital
        • Contact:
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
      • Changchun, China, 130021
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410008
        • Xiangya Hospital, Central South University
        • Contact:
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
        • Contact:
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510630
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Hangzhou, China, 310009
        • the Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hefei, China, 230001
      • Luoyang, China, 471003
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
      • Nanchang, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China, 210008
      • Ningbo, China, 315010
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 201112
        • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
        • Contact:
      • Shenzhen, China, 518033
        • The Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Sichuan, China, 610031
        • People's Hospital of Sichuan Province
        • Contact:
      • Tianjin, China, 30052
        • Tianjin Medical University General Hospital
        • 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:
      • Xiamen, China, 361003
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Xuzhou, China, 221006
        • Affiliated Hospital, Xuzhou Medical college
        • Contact:
      • Zhuzhou, China, 412007
  • Colombia
      • Bogotá, Colombia, 110231
        • CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
        • Contact:
      • Bogotá, Colombia, 110231
        • Hospital Universitario San Ignacio de Bogotá
        • Contact:
      • Bogotá, Colombia, 111411
        • Corporación Hospitalaria Juan Ciudad, Sede denominada Méderi
        • Contact:
      • Medellín, Colombia, 50034
        • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana
        • Contact:
  • Croatia
      • Osijek, Croatia, 31000
      • Rijeka, Croatia, 51000
      • Zagreb, Croatia, 10000
  • Czechia
      • Brno, Czechia, 625 00
      • Prague, Czechia, 12800
  • Denmark
      • Copenhagen, Denmark, 2100
      • Odense C, Denmark, 5000
  • Estonia
      • Tallinn, Estonia, 11312
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation, Tallinn
        • Contact:
      • Tartu, Estonia, 50406
  • Finland
      • Helsinki, Finland, 00290
      • Oulu, Finland, 90150
        • Northern Clinical Trial Coordinators
        • Contact:
      • Turku, Finland, 20520
        • Turku University Hospital / TYKS
        • Contact:
  • France
      • Bordeaux, France, 33076
      • Brest, France, 29200
      • Caen, France, 14000
      • Epagny Metz-Tessy, France, 74370
      • Paris, France, 75014
      • Rennes, France, 35000
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
      • Tours, France, 37044
  • Georgia
      • Tbilisi, Georgia, 0159
        • Emergency Cardiology Center by Academician G. Chapidze
        • Contact:
      • Tbilisi, Georgia, 112
        • LTD Israeli-Georgian Medical Research Clinic Healthycore
        • Contact:
      • Tbilisi, Georgia, 141
        • LEPL The First University Clinic of Tbilisi State Medical University
        • Contact:
      • Tbilisi, Georgia, 179
  • Germany
      • Bad Bramstedt, Germany, 24576
      • Berlin, Germany, 13125
      • Dresden, Germany
      • Hanover, Germany, 30625
      • Heidelberg, Germany, 69120
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Contact:
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • Münster, Germany
      • Oberhausen, Germany, 46045
      • Tübingen, Germany, 72076
      • Vogelsang, Germany, 39245
  • Greece
      • Athens, Greece, 151 23
      • Ioannina, Greece, 45 500
      • Thessaloniki, Greece, 546 42
        • General Hospital of Thessaloniki "Ippokrateio"
        • Contact:
  • Hungary
  • India
      • Bhubaneswar, India, 751019
      • Hyderabad, India, 500082
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Kochi, India, 682040
      • Maharashtra, India, 400053
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
        • Contact:
      • New Delhi, India, 110029
  • Israel
      • Kfar Saba, Israel, 44281
      • Ramat Gan, Israel, 52621
  • Italy
      • Ancona, Italy, 60123
        • Azienda Ospedaliero Universitaria delle Marche
        • Contact:
      • Bari, Italy, 70124
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contact:
      • Florence, Italy, 50134
      • Milan, Italy, 20132
      • Milan, Italy, 20122
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena
        • Contact:
      • Naples, Italy, 80131
        • AOU Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
      • Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Aichi, Toyoake, Japan, 470-1192
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Gifu, Gifu, Japan, 500-8717
        • Gifu Prefectural General Medical Center
        • Contact:
      • Hiroshima, Hiroshima, Japan, 734-8551
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
      • Ishikawa, Kanazawa, Japan, 920-8641
      • Kagawa, Kita-gun, Japan, 761-0793
      • Kanagawa, Kawasaki, Japan, 216-8511
      • Kanagawa, Sagamihara, Japan, 252-0375
      • Kanagawa, Yokohama, Japan, 236-0004
      • Kyoto, Kyoto, Japan, 606-8507
      • Miyagi, Sendai, Japan, 983-8512
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
      • Osaka, Takatsuki, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
      • Saitama, Iruma-gun, Japan, 350-0495
        • Saitama Medical University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
      • Tokyo, Shinjuku-ku, Japan, 160-8582
      • Toyama, Toyama, Japan, 930-0194
  • Lithuania
      • Kaunas, Lithuania, 51270
      • Vilnius, Lithuania, 08406
  • Malaysia
      • Batu Caves, Malaysia, 68100
      • Kuala Lumpur, Malaysia, 59100
      • Kuching, Malaysia, 93586
  • Mexico
      • Chihuahua City, Mexico, 31020
        • Investigacion y Biomedicina de Chihuahua S.C.
        • Contact:
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • Contact:
      • Guadalajara, Mexico, 44160
        • Centro Integral en Reumatologia, SA. de CV.
        • Contact:
      • Jalisco, Mexico, 45170
      • 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:
      • Tlalnepantla, Mexico, 54055
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
      • Nijmegen, Netherlands, 6525 GA
      • Utrecht, Netherlands, 3584 CX
  • New Zealand
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
  • Norway
      • Kristiansand, Norway, 4615
        • Sørlandet sykehus HF Kristiansand
        • Contact:
      • Levanger, Norway, 7600
      • Lillehammer, Norway, 2609
      • Oslo, Norway, 0372
        • Oslo Universitetssykehus HF, Rikshospitalet
        • Contact:
      • Stavanger, Norway, 4011
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Philippines
      • Manila, Philippines, 1000
      • Metro Manil, Philippines, 1218
      • Taft, Manila, Philippines, 1000
  • Poland
      • Bialystok, Poland, 15-276
        • University Clinical Hospital in Bialystok I
        • Contact:
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
        • Contact:
      • Krakow, Poland, 30-002
      • Poznan, Poland, 60-218
      • Warsaw, Poland, 00874
        • Medicover Integrated Clinical Services Sp. z o.o.
        • Contact:
  • Portugal
      • Almada, Portugal, 2801-951
        • ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
        • Contact:
      • Coimbra, Portugal, 3000-075
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1649-035
      • Ponte de Lima, Portugal, 4990-041
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário São João,EPE
        • Contact:
      • Porto, Portugal, 4434-502
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
        • Contact:
  • Romania
      • Bucharest, Romania, 030463
      • Bucharest, Romania, 014142
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean De Urgenta Cluj
        • Contact:
      • Constanța, Romania, 900622
        • Aqua Clinic (AquaMed Consulting SRL- juridic)
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
  • South Africa
      • Stellenbosch, South Africa, 7599
  • South Korea
      • Seoul, South Korea, 03080
      • Seoul, South Korea, 04401
        • Soonchunhyang University Hospital Seoul
        • Contact:
      • Seoul, South Korea, 02447
      • Suwon, South Korea, 16499
  • Spain
      • Badalona, Spain, 08916
      • Barakaldo, Spain, 48903
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Huelva, Spain, 21005
      • L'Hospitalet Del Llobregat, Spain, 08907
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Sabadell, Spain, 08208
      • Valencia, Spain, 46017
  • Sweden
      • Stockholm, Sweden, 171 76
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
  • Taiwan
      • Taichung, Taiwan, 404
      • Taichung, Taiwan, 40705
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Thailand, 10400
      • Bangkoknoi, Thailand, 10700
      • Khon Kaen, Thailand, 40002
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Scottsdale, Arizona, United States, 85032
        • Arizona Arthritis and Rheumatology Associates - Paradise Valley
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92108
      • Stanford, California, United States, 94305
      • Whittier, California, United States, 90602
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
    • Florida
      • Ormond Beach, Florida, United States, 32174
      • Plantation, Florida, United States, 33324
      • South Miami, Florida, United States, 33143
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Saint Clair Shores, Michigan, United States, 48081
        • Clinical Research Institute of Michigan, LLC - St. Clair Shores
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • New York, New York, United States, 10029
      • New York, New York, United States, 10021
      • New York, New York, United States, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
    • Tennessee
      • Jackson, Tennessee, United States, 38305
    • Texas
      • Allen, Texas, United States, 75013
      • Austin, Texas, United States, 78745
      • Houston, Texas, United States, 77030
  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
      • Hà Nội, Vietnam

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. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria for SSc.
  3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).
  4. Disease onset (defined by first non-RP [Raynaud's phenomenon] symptom) must be within 7 years of Visit 1.
  5. Trial participants with dcSSc must have evidence of active disease during screening.
  6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.
  7. FVC % predicted ≥45% at Visit 1.
  8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.
  9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.
  10. Patients may be either untreated or on stable treatment with permitted immunosuppressive/immunomodulatory agents and/or nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period

Exclusion criteria:

  1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.
  2. Any suicidal behaviour in the past 2 years.
  3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. 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
Placebo Comparator: Placebo
Drug: Placebo matching nerandomilast formulation 1
Film-coated tablets
Drug: Placebo matching nerandomilast formulation 2
Film-coated tablets
Experimental: Nerandomilast
Drug: Nerandomilast formulation 1
Film-coated tablets
Drug: Nerandomilast formulation 2
Film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to the first occurrence of disease progression or all-cause death
Time Frame: up to 4 years
up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mRSS at Week 52
Time Frame: At baseline and at Week 52.

The modified Rodnan Skin Score (mRSS) measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold).

The total mRSS ranges from 0 (best possible outcome) to 51 (worst possible outcome).
At baseline and at Week 52.
Change from baseline in HAQ-DI score at Week 52
Time Frame: At baseline and at Week 52.

Health Assessment Questionnaire Disability Index (HAQ-DI) is used frequently in rheumatological disorders including SSc, assessing function/activities of daily living with 20 items in 8 categories, namely dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities.

Each category has at least 2 sub-category questions. Within each category, patients report the amount of difficulty they have in performing the specific sub-category items.

There are four response options ranging from "no difficulty" to "unable to do", scored 0 to 3.

A global score will be calculated from the category scores with higher scores indicating more severe disability.
At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
Time Frame: At baseline and at Week 52.
Forced vital capacity (FVC)
At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 at Week 52
Time Frame: At baseline and at Week 52.

Revised composite response index in systemic sclerosis (rCRISS) is a composite outcome measure developed for SSc that includes PRO and clinician-reported outcome (ClinRO) measures:

  • mRSS
  • FVC %
  • HAQ-DI
  • Patient Global Assessment (PGA) of overall health status
  • Clinician Global Assessment (CGA) of overall health status

For rCRISS-25 a patient has improvement on at least 2 of the 5 core set measures and without worsening on more than 1 core set measure. The improvement or worsening must be at least 25% relative change from the baseline for 4 core set measures (or ≥5% relative change from baseline for FVC % predicted).
At baseline and at Week 52.
Time to first occurrence of confirmed absolute decline from baseline in FVC % predicted ≥5% (for patients with ILD at baseline) or newly diagnosed ILD (for patients without ILD at baseline) or death
Time Frame: up to 4 years
up to 4 years
Time to first occurrence of absolute increase in mRSS ≥5 points and relative increase from baseline in mRSS ≥25% or death
Time Frame: up to 4 years
up to 4 years
Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death
Time Frame: up to 4 years
up to 4 years
Time to all-cause death
Time Frame: up to 4 years
up to 4 years
Change from baseline in Systemic Sclerosis Impact of Disease (ScleroID) score at Week 52
Time Frame: At baseline and at Week 52.

The Systemic Sclerosis Impact of Disease (ScleroID) is a patient reported outcome (PRO) measure specifically developed to assess how SSc affects a person's life.

The ScleroID has 10 items and it covers 10 domains. Every item is rated on a 0-10 numeric rating scale and the individual scores are computed using a weighted sum, resulting in a final score ranging from 0 to 10.

A higher score means a higher impact of disease.
At baseline and at Week 52.
Change from baseline in digital ulcer total burden at Week 52
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.

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)

June 9, 2026

Primary Completion (Estimated)

February 26, 2030

Study Completion (Estimated)

March 17, 2030

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0052
  • 2025-523884-39-00 (Registry Identifier: CTIS (EU))
  • U1111-1329-6365 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

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'spublication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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