Clinical trial • Phase II • Immunology
IMEROPRUBART for Cutaneous lupus erythematosus | Subacute cutaneous lupus erythematosus (SCLE) | Chronic cutaneous lupus erythematosus (CCLE)
Phase II trial of IMEROPRUBART for Cutaneous lupus erythematosus | Subacute cutaneous lupus erythematosus (SCLE) | Chronic cutaneous lupus erythematosus (…
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Cutaneous lupus erythematosus | Subacute cutaneous lupus erythematosus (SCLE) | Chronic cutaneous lupus erythematosus (CCLE)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 24-06-2025
Trial design
Randomised, placebo (identical to the imp but with no active substance). dose/schedule not specified in the provided record.-controlled Phase II trial across 29 sites in Bulgaria, Greece, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo (identical to the IMP but with no active substance). Dose/schedule not specified in the provided record.
- Target Sample Size
- 46
Eligibility
Recruits 46 The record indicates isVulnerablePopulationSelected:false — no vulnerable populations selected; specific assent/consent handling for vulnerable groups is not specified in the provided record..
- Vulnerable Population
- The record indicates isVulnerablePopulationSelected:false — no vulnerable populations selected; specific assent/consent handling for vulnerable groups is not specified in the provided record.
Inclusion criteria
- {"criterion_text":"- Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations."}
- {"criterion_text":"- Have a total CLASI-A score of ≥ 10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions."}
- {"criterion_text":"- Have active CLE despite an adequate trial of conventional therapies (defined as either corticosteroids or an antimalarial agent used for at least 12-week prior to Screening) OR previously documented failure to respond to these agents when used for at least 12 weeks OR the requirement to discontinue these agents due to side effects and poor tolerability."}
- {"criterion_text":"- Are positive for at least one of the following as assessed at Screening: a. ANA; b. elevated anti-double-stranded DNA; c. anti-Ro/SSA; d. anti-La/SSB; e. anti-Sm; f. anti-RNP70; g. positive direct immunofluorescence confirming IgG deposition in a skin biopsy."}
Exclusion criteria
- {"criterion_text":"- Have known or suspected drug-induced CLE, anti-phospholipid disease, or neuropsychiatric SLE."}
- {"criterion_text":"- Have rapidly progressive nephritis."}
- {"criterion_text":"- Have current inflammatory skin disease other than SCLE / CCLE that, in the opinion of the investigator, could interfere with the inflammatory skin assessments or confound disease activity assessments."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent change from Period 1 baseline in CLASI-A score at Week 12.","definition_or_measurement_approach":"Percent change from Period 1 baseline in CLASI-A score measured at Week 12 (CLASI-A = Cutaneous Lupus Activity Severity Index - Activity score)."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ≥5-point reduction in CLASI-A from Period 1 baseline at Week 12."}
- {"endpoint_text":"- Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction in CLASI-A from Period 1 baseline at Week 12."}
- {"endpoint_text":"- Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ≥70% reduction in CLASI-A from Period 1 baseline at Week 12."}
Recruitment
- Registry Or Advocacy Recruitment
- True - Advocacy Group Study Alert materials are listed (country-specific). Additionally 'Training Program for Lupus (LFA-POINT Program)' is referenced in third-party duties.
- Digital Remote Recruitment
- True - materials include 'Innovative Trials Storyboard' and use of eCOA/eDiary (Clinical Ink) and digital brochures/storyboards; specific digital channel details are not further specified.
- Planned Sample Size
- 46
- Recruitment Window Months
- 20
- Consent Approach
- Informed consent is obtained using L1_SIS and ICF subject information and informed consent form documents; versions/translations are provided in English, Bulgarian, Greek, Spanish, Polish and German. A 'Pregnant Partner' information/ICF document is included. Consent is to be provided by the participant; no assent/minor-specific consent procedures are specified in the provided record.
Methods
- Study brochures and trifold brochures (country-specific) — printed/digital study brochures referenced for BG, GR, ES, PL, DE.
- Study posters (country-specific) — posters for BG, GR, ES, PL, DE.
- Dr-to-Dr letters (country-specific) — materials titled 'Dr to Dr Letter' for BG, GR, ES, PL, DE targeting physicians/investigators.
- Advocacy Group Study Alert (country-specific) — materials to notify advocacy groups (BG, GR, ES, PL, DE).
- Innovative Trials Storyboard (country-specific) — recruitment storyboard materials (likely digital/visual) for multiple countries.
- Clariness/Clariness EC Documents and local recruitment arrangements (country-specific) — vendor-supported patient recruitment activities listed for several countries.
- Patient reimbursement and patient recruitment support by third parties (e.g., Scout Clinical, Clariness, Innovative Trials) as indicated in third-party duties.
- Use of eCOA/eDiary (Clinical Ink) for patient-reported data capture (linked to study conduct and retention).
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 46
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 187
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Diagnostic Consultation Center XX-Sofia EOOD
- Department Name
- Diagnostic Consultative Center XX - Sofia EOOD
- Principal Investigator Name
- Toma Tomov
- Principal Investigator Email
- dr.toma.tomov2015@gmail.com
- Contact Person Name
- Toma Tomov
- Contact Person Email
- dr.toma.tomov2015@gmail.com
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- Diagnostic Consultative Center
- Principal Investigator Name
- Vladimira Boyadzhieva
- Principal Investigator Email
- vladimira.boyadzhieva@gmail.com
- Contact Person Name
- Vladimira Boyadzhieva
- Contact Person Email
- vladimira.boyadzhieva@gmail.com
- Site Name
- Alexandrovska University Hospital
- Department Name
- Clinic of Skin and Venereal diseases
- Principal Investigator Name
- Krassimir Yanev
- Principal Investigator Email
- dr_k.yanev@yahoo.com
- Contact Person Name
- Krassimir Yanev
- Contact Person Email
- dr_k.yanev@yahoo.com
- Site Name
- Military Medical Academy
- Department Name
- Dermatology and Venereology Clinic
- Principal Investigator Name
- Vessel Kantardjiev
- Principal Investigator Email
- v.kantarjiev@vma.bg
- Contact Person Name
- Vessel Kantardjiev
- Contact Person Email
- v.kantarjiev@vma.bg
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Clinic of Medical Oncology
- Principal Investigator Name
- Petranka Troyanova
- Principal Investigator Email
- prof.petranka.troyanova@gmail.com
- Contact Person Name
- Petranka Troyanova
- Contact Person Email
- prof.petranka.troyanova@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 255
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 2nd Department of Dermatology-Venereology
- Principal Investigator Name
- Elizabeth Lazaridou
- Principal Investigator Email
- bethlaz@auth.gr
- Contact Person Name
- Elizabeth Lazaridou
- Contact Person Email
- bethlaz@auth.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Dimitrios Boumpas
- Principal Investigator Email
- boumpasd@uoc.gr
- Contact Person Name
- Dimitrios Boumpas
- Contact Person Email
- boumpasd@uoc.gr
- Site Name
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
- Department Name
- 1st Department of Dermatology-Venereology
- Principal Investigator Name
- Alexandros Stratigos
- Principal Investigator Email
- alstrat2@gmail.com
- Contact Person Name
- Alexandros Stratigos
- Contact Person Email
- alstrat2@gmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- Dermatology
- Principal Investigator Name
- Efterpi Zafeiriou
- Principal Investigator Email
- zafevi@o365.uth.gr
- Contact Person Name
- Efterpi Zafeiriou
- Contact Person Email
- zafevi@o365.uth.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Dermatology
- Principal Investigator Name
- Konstantinos Krasagakis
- Principal Investigator Email
- krasagak@med.uoc.gr
- Contact Person Name
- Konstantinos Krasagakis
- Contact Person Email
- krasagak@med.uoc.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Clinic of Venereal and Dermatology Diseases
- Principal Investigator Name
- Evangelia Papadavid
- Principal Investigator Email
- papadavev@yahoo.gr
- Contact Person Name
- Evangelia Papadavid
- Contact Person Email
- papadavev@yahoo.gr
- Site Name
- Euromedica Kyanous Stavros
- Department Name
- Rheumatology
- Principal Investigator Name
- Lucas Settas
- Principal Investigator Email
- loukassettas@gmail.com
- Contact Person Name
- Lucas Settas
- Contact Person Email
- loukassettas@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 12-06-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 228
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Imed Valencia
- Department Name
- Dermatology
- Principal Investigator Name
- Magdalena Silla Prosper
- Principal Investigator Email
- mmsilla@imedhospitales.com
- Contact Person Name
- Magdalena Silla Prosper
- Contact Person Email
- mmsilla@imedhospitales.com
- Site Name
- Futuremeds Spain S.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Jacqueline Uson Jaeger
- Principal Investigator Email
- emag@futuremeds.com
- Contact Person Name
- Jacqueline Uson Jaeger
- Contact Person Email
- emag@futuremeds.com
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Internal Medicine
- Principal Investigator Name
- Patricia Fanlo Mateo
- Principal Investigator Email
- patricia.fanlo.mateo@navarra.es
- Contact Person Name
- Patricia Fanlo Mateo
- Contact Person Email
- patricia.fanlo.mateo@navarra.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Dermatology Venereology
- Principal Investigator Name
- Jon Fulgencio Barbarin
- Principal Investigator Email
- jonfulgencio@hotmail.com
- Contact Person Name
- Jon Fulgencio Barbarin
- Contact Person Email
- jonfulgencio@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Dermatology
- Principal Investigator Name
- Maria Isabel Bielsa Marsol
- Principal Investigator Email
- mariaisabel.bielsa@uab.cat
- Contact Person Name
- Maria Isabel Bielsa Marsol
- Contact Person Email
- mariaisabel.bielsa@uab.cat
- Site Name
- Hospital Vithas Parque San Antonio
- Department Name
- Internal Medicine
- Principal Investigator Name
- Enrique Iglesias Julian
- Principal Investigator Email
- enrique.iglesias@vithas.es
- Contact Person Name
- Enrique Iglesias Julian
- Contact Person Email
- enrique.iglesias@vithas.es
Poland
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 264
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Katarzyna Romanowska-Prochnicka
- Principal Investigator Email
- kontakt@medycynakliniczna.pl
- Contact Person Name
- Katarzyna Romanowska-Prochnicka
- Contact Person Email
- kontakt@medycynakliniczna.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Dermatology Venereology
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Synexus Polska Sp. z o.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Karolina Antkowiak-Piatyszek
- Principal Investigator Email
- karolina.antkowiak@globalaes.com
- Contact Person Name
- Karolina Antkowiak-Piatyszek
- Contact Person Email
- karolina.antkowiak@globalaes.com
- Site Name
- Klinika Osipowicz & Turkowski Sp. z o.o.
- Department Name
- Dermatology Venereology
- Principal Investigator Name
- Katarzyna Osipowicz
- Principal Investigator Email
- osipowicz.kasia@gmail.com
- Contact Person Name
- Katarzyna Osipowicz
- Contact Person Email
- osipowicz.kasia@gmail.com
- Site Name
- Somed Cr Sp. z o.o. sp.k.
- Principal Investigator Name
- Jerzy Maciag
- Principal Investigator Email
- jerzy.maciag@somed.pl
- Contact Person Name
- Jerzy Maciag
- Contact Person Email
- jerzy.maciag@somed.pl
- Site Name
- Dermoklinika-Centrum Medyczne s.c
- Department Name
- Dermatology Venereology
- Principal Investigator Name
- Joanna Narbutt
- Principal Investigator Email
- joanna.narbutt@onet.pl
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- joanna.narbutt@onet.pl
- Site Name
- P&P Beauty Clinic s.c
- Department Name
- Dermatology Venereology
- Principal Investigator Name
- Zofia Polakowska
- Principal Investigator Email
- zpolakowska@gmail.com
- Contact Person Name
- Zofia Polakowska
- Contact Person Email
- zpolakowska@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 264
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Psoriasis Zentrum - Hautklinik, Internistisches Zentrum
- Principal Investigator Name
- Michael Sticherling
- Principal Investigator Email
- michael.sticherling@uk-erlangen.de
- Contact Person Name
- Michael Sticherling
- Contact Person Email
- michael.sticherling@uk-erlangen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Immundermatologie
- Principal Investigator Name
- Matthias Hahn
- Principal Investigator Email
- Matthias.hahn@med.uni-tuebingen.de
- Contact Person Name
- Matthias Hahn
- Contact Person Email
- Matthias.hahn@med.uni-tuebingen.de
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- Dermatologie und Allergologie
- Principal Investigator Name
- Nikolaos Patsinakidis
- Principal Investigator Email
- Patsinakidis.nikolaos@klinikum-oldenburg.de
- Contact Person Name
- Nikolaos Patsinakidis
- Contact Person Email
- Patsinakidis.nikolaos@klinikum-oldenburg.de
- Site Name
- St. Josef-Hospital
- Department Name
- Dermatology
- Principal Investigator Name
- Falk Georges Bechara
- Principal Investigator Email
- falk.bechara@klinikum-bochum.de
- Contact Person Name
- Falk Georges Bechara
- Contact Person Email
- falk.bechara@klinikum-bochum.de
Sponsor
Primary sponsor
- Full Name
- Immunovant Sciences GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties codes: 1; 5
- Name
- PPD Global Ltd.
- Responsibilities
- sponsorDuties codes: 1; 5
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- sponsorDuties code: 4
- Name
- Medpace Reference Laboratories LLC
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"United States","full_name":"Crisalis","duties_or_roles":"Training Program for Lupus (LFA-POINT Program)","organisation_type":"Industry"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography / Equipment Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Exagen Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1; 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA and eDiary","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: 1; 5","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient recruitement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Avance Biosciences Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursment","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Recruitment support","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long-term storage","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences (additional entry)","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- IMVT-1402
- Active Substance
- IMEROPRUBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- Max daily dose 600 mg; max total dose 31200 mg
- Investigational Product Name
- Placebo is identical to the IMP but with no active substance.
- Modality
- Other
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