Clinical trial • Phase II • Dermatology
EVO756 POTASSIUM for Chronic spontaneous urticaria | Moderate to severe chronic spontaneous urticaria
Phase II trial of EVO756 POTASSIUM for Chronic spontaneous urticaria | Moderate to severe chronic spontaneous urticaria.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Chronic spontaneous urticaria | Moderate to severe chronic spontaneous urticaria
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 19-06-2025
Trial design
Randomised, placebo (oral tablet), dose/schedule not specified-controlled Phase II trial in Spain, Hungary, Poland and others.
- Randomised
- Yes
- Comparator
- PLACEBO (oral tablet), dose/schedule not specified
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 101
- Trial Duration For Participant
- 84
Eligibility
Recruits 101 The trial indicates vulnerable population selection (isVulnerablePopulationSelected: true). Inclusion requires participants to be capable of providing written informed consent; participants must be adults (≥18). No assent procedures for minors are provided..
- Vulnerable Population
- The trial indicates vulnerable population selection (isVulnerablePopulationSelected: true). Inclusion requires participants to be capable of providing written informed consent; participants must be adults (≥18). No assent procedures for minors are provided.
Inclusion criteria
- {"criterion_text":"- Male or female, ages ≥ 18 at Screening"}
- {"criterion_text":"- Capable of providing written informed consent and willing and able to comply with study requirements"}
- {"criterion_text":"- Confirmed CSU diagnosis for ≥ 3 months with an inadequate response to H1 antihistamines"}
- {"criterion_text":"- Urticaria Activity Score (UAS7) ≥ 16 at Day 1, with completed UAS entries for a minimum of 4 out of the 7 days prior to Day 1"}
- {"criterion_text":"- Subjects taking H1 antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study."}
Exclusion criteria
- {"criterion_text":"- Use of the following medications for the timeframes specified below and while on study: o\tBiologics (e.g., omalizumab, dupilumab, tezepelumab, ligelizumab) for 120 days or 5 half-lives (whichever is longer) prior to Day 1, o\tCyclosporine, methotrexate, sulfonamides, systemic glucocorticoids (e.g., prednisone), or mycophenolate for 28 days prior to Day 1, o\tLeukotriene inhibitors (e.g., montelukast, zafirlukast) for 14 days prior to Day 1 (if taken for CSU), o\tH2-receptor antagonists (e.g., ranitidine, famotidine) for 14 days prior to Day 1 (if taken for CSU)."}
- {"criterion_text":"- History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema."}
- {"criterion_text":"- Any other skin disease that might confound the assessment of CSU in the Investigator's opinion."}
- {"criterion_text":"- AST, ALT, alkaline phosphatase, or total bilirubin above the ULN at Screening."}
- {"criterion_text":"- (No additional explicit exclusion criteria provided beyond those listed.)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean change from baseline in UAS7 at Week 12","definition_or_measurement_approach":"Mean change from baseline in UAS7 score at Week 12"}
Secondary endpoints
- {"endpoint_text":"- Percent change from baseline in UAS7 at Week 12","definition_or_measurement_approach":"Percent change from baseline in UAS7 at Week 12"}
- {"endpoint_text":"- Mean and percent change from baseline in UAS7 at Weeks 1, 2, 4, 8","definition_or_measurement_approach":"Mean and percent change from baseline in UAS7 at Weeks 1, 2, 4, 8"}
- {"endpoint_text":"- Mean and percent change from baseline in ISS7 at Weeks 1, 2, 4, 8, 12","definition_or_measurement_approach":"Mean and percent change from baseline in ISS7 at Weeks 1, 2, 4, 8, 12"}
- {"endpoint_text":"- Mean and percent change from baseline in HSS7 at Weeks 1, 2, 4, 8, 12","definition_or_measurement_approach":"Mean and percent change from baseline in HSS7 at Weeks 1, 2, 4, 8, 12"}
- {"endpoint_text":"- Mean and percent change from baseline in AAS7 at Weeks 1, 2, 4, 8, 12","definition_or_measurement_approach":"Mean and percent change from baseline in AAS7 at Weeks 1, 2, 4, 8, 12"}
- {"endpoint_text":"- Proportion of subjects achieving UAS7 ≤ 6 and UAS7 = 0","definition_or_measurement_approach":"Proportion of subjects achieving specified UAS7 thresholds during treatment"}
Recruitment
- Planned Sample Size
- 101
- Recruitment Window Months
- 11
- Consent Approach
- Written informed consent by the participant (participants must be capable of providing written informed consent and are adults ≥18). Subject information and informed consent form (SIS and ICF) documents are provided; multiple language versions available (including English, Spanish, Bulgarian, Hungarian, Polish, German, Italian and localized versions). No assent for minors is described.
Methods
- Flyer (patient-facing) - document titles include K2_Flyer and multiple localized flyer versions
- Dr to Patient letter (K2_Dr to Patient letter) - used to inform patients via their treating physician
- GP Letter (country-specific GP letters present e.g. K2_GP Letter)
- Brochure (Bifold and Trifold) - patient-facing brochures (multiple language versions)
- Inclusion/Exclusion card (K2_Inclusion Exclusion card) - quick eligibility summary
- Study Participation Card / Patient Card (L2_Study Participation Card)
- Recruitment arrangements documents (K1_Recruitment arrangements) including localized versions (e.g., DE, ITA, BGR)
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 63
Spain
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 19-06-2025
- Processing Time Days
- 24
- Number Of Sites
- 10
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Allergy
- Principal Investigator Name
- Francisca Gomez Perez
- Principal Investigator Email
- estudios.clinicos@ibima.eu
- Contact Person Name
- Francisca Gomez Perez
- Contact Person Email
- estudios.clinicos@ibima.eu
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Allergy
- Principal Investigator Name
- Montserrat Fernandez Rivas
- Principal Investigator Email
- mariamontserrat.fernandez@salud.madrid.org
- Contact Person Name
- Montserrat Fernandez Rivas
- Contact Person Email
- mariamontserrat.fernandez@salud.madrid.org
- Site Name
- Clínica de asma y alergia Dres. Ojeda
- Department Name
- Allergy
- Principal Investigator Name
- Pedro Ojeda
- Principal Investigator Email
- pedro.ojeda@clinicaojeda.es
- Contact Person Name
- Pedro Ojeda
- Contact Person Email
- pedro.ojeda@clinicaojeda.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Allergy
- Principal Investigator Name
- Moises Labrador Horrillo
- Principal Investigator Email
- moises.labrador@vallhebron.cat
- Contact Person Name
- Moises Labrador Horrillo
- Contact Person Email
- moises.labrador@vallhebron.cat
- Site Name
- Hospital Del Mar
- Department Name
- Dermatology
- Principal Investigator Name
- Ana Maria Gimenez Arnau
- Principal Investigator Email
- 22505aga@comb.cat
- Contact Person Name
- Ana Maria Gimenez Arnau
- Contact Person Email
- 22505aga@comb.cat
- Site Name
- Hospital Nuestra Senora De Sonsoles
- Department Name
- Allergy
- Principal Investigator Name
- Maria Aranzazu Jimenez Blanco
- Principal Investigator Email
- majimenezb@saludcastillayleon.es
- Contact Person Name
- Maria Aranzazu Jimenez Blanco
- Contact Person Email
- majimenezb@saludcastillayleon.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Jorge Luis Spertino
- Principal Investigator Email
- jspertino@santpau.cat
- Contact Person Name
- Jorge Luis Spertino
- Contact Person Email
- jspertino@santpau.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Allergy
- Principal Investigator Name
- Francisco Javier Muñoz Bellido
- Principal Investigator Email
- fjmbellido@saludcastillayleon.es
- Contact Person Name
- Francisco Javier Muñoz Bellido
- Contact Person Email
- fjmbellido@saludcastillayleon.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Allergy
- Principal Investigator Name
- Laura Victoria Carpio Escalona
- Principal Investigator Email
- lauvce@gmail.com
- Contact Person Name
- Laura Victoria Carpio Escalona
- Contact Person Email
- lauvce@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Allergy
- Principal Investigator Name
- Carlos Blanco Guerra
- Principal Investigator Email
- alg.hlpr@salud.madrid.org
- Contact Person Name
- Carlos Blanco Guerra
- Contact Person Email
- alg.hlpr@salud.madrid.org
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 20-06-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- University Of Debrecen
- Department Name
- Dermatology
- Principal Investigator Name
- Andrea Szegedi
- Principal Investigator Email
- aszegedi@med.unideb.hu
- Contact Person Name
- Andrea Szegedi
- Contact Person Email
- aszegedi@med.unideb.hu
- Site Name
- Geomedical Kft.
- Principal Investigator Name
- Marta Foldes
- Principal Investigator Email
- drfoldesmarta@gmail.com
- Contact Person Name
- Marta Foldes
- Contact Person Email
- drfoldesmarta@gmail.com
- Site Name
- KomplexLabor Kft.
- Principal Investigator Name
- Doniz Degovics
- Principal Investigator Email
- degovicsd@hotmail.com
- Contact Person Name
- Doniz Degovics
- Contact Person Email
- degovicsd@hotmail.com
- Site Name
- University Of Szeged
- Department Name
- Dermatology
- Principal Investigator Name
- Zsuzsanna Bata
- Principal Investigator Email
- bata.zsuzsa@med.u-szeged.hu
- Contact Person Name
- Zsuzsanna Bata
- Contact Person Email
- bata.zsuzsa@med.u-szeged.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 24-06-2025
- Processing Time Days
- 32
- Number Of Sites
- 10
- Number Of Participants
- 11
Sites
- Site Name
- Dr Sekowska Leczenie Bolu
- Principal Investigator Name
- Alicja Parysek Burdach
- Principal Investigator Email
- alicja.parysek@gmail.com
- Contact Person Name
- Alicja Parysek Burdach
- Contact Person Email
- alicja.parysek@gmail.com
- Site Name
- Vita Longa Sp. z o.o.
- Principal Investigator Name
- Elzbieta Meszynska
- Principal Investigator Email
- biuro@researchsolutions.pl
- Contact Person Name
- Elzbieta Meszynska
- Contact Person Email
- biuro@researchsolutions.pl
- Site Name
- Jagiellońskie Centrum Innowacji Sp. z o.o.
- Principal Investigator Name
- Magdalena Nastalek
- Principal Investigator Email
- nastalekmag@gmail.com
- Contact Person Name
- Magdalena Nastalek
- Contact Person Email
- nastalekmag@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
- Department Name
- Klinika Dermatologii
- Principal Investigator Name
- Reich Adam
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Reich Adam
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Gyncentrum Sp. z o.o.
- Principal Investigator Name
- Marcin Zakrzewski
- Principal Investigator Email
- m.zemelka@holsaclinical.com
- Contact Person Name
- Marcin Zakrzewski
- Contact Person Email
- m.zemelka@holsaclinical.com
- Site Name
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
- Principal Investigator Name
- Jacek Szepietowski
- Principal Investigator Email
- jacek.szepietowski.work@gmail.com
- Contact Person Name
- Jacek Szepietowski
- Contact Person Email
- jacek.szepietowski.work@gmail.com
- Site Name
- Klinika Osipowicz & Turkowski Sp. z o.o.
- Principal Investigator Name
- Katarzyna Osipowicz
- Principal Investigator Email
- badaniakliniczne@klinikaotco.pl
- Contact Person Name
- Katarzyna Osipowicz
- Contact Person Email
- badaniakliniczne@klinikaotco.pl
- Site Name
- Twoja-Med
- Principal Investigator Name
- Santa Vanaga-Besser
- Principal Investigator Email
- s.vanaga-besser@twoja-klinika.pl
- Contact Person Name
- Santa Vanaga-Besser
- Contact Person Email
- s.vanaga-besser@twoja-klinika.pl
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak
- Principal Investigator Name
- Magdalena Boczarska- Jedynak
- Principal Investigator Email
- m.boczarskajedynak@gmail.com
- Contact Person Name
- Magdalena Boczarska- Jedynak
- Contact Person Email
- m.boczarskajedynak@gmail.com
- Site Name
- Therapia Nova Sp. z o.o.
- Principal Investigator Name
- Ryszard Galus
- Principal Investigator Email
- GALUSMED@GMAIL.COM
- Contact Person Name
- Ryszard Galus
- Contact Person Email
- GALUSMED@GMAIL.COM
Germany
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 23-06-2025
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Institute of Allergology (IFA)
- Principal Investigator Name
- Martin Metz
- Principal Investigator Email
- martin.metz@charite.de
- Contact Person Name
- Martin Metz
- Contact Person Email
- martin.metz@charite.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Clinic for Dermatology, Venereology and Allergology
- Principal Investigator Name
- Andreas Pinter
- Principal Investigator Email
- Andreas.Pinter@unimedizin-ffm.de
- Contact Person Name
- Andreas Pinter
- Contact Person Email
- Andreas.Pinter@unimedizin-ffm.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Wiebke Sondermann
- Principal Investigator Email
- Wiebke.sondermann@uk-essen.de
- Contact Person Name
- Wiebke Sondermann
- Contact Person Email
- Wiebke.sondermann@uk-essen.de
- Site Name
- Emovis GmbH (Offenbach Am Main)
- Principal Investigator Name
- Reinhard Hermann Alois Stöhring
- Principal Investigator Email
- reinhard.stoehring@futuremeds.com
- Contact Person Name
- Reinhard Hermann Alois Stöhring
- Contact Person Email
- reinhard.stoehring@futuremeds.com
- Site Name
- Emovis GmbH (Berlin)
- Principal Investigator Name
- Saskia Kerschischnik
- Principal Investigator Email
- Saskia.kerschischnik@futuremeds.com
- Contact Person Name
- Saskia Kerschischnik
- Contact Person Email
- Saskia.kerschischnik@futuremeds.com
- Site Name
- Technische Universitaet Dresden
- Department Name
- Dermatology
- Principal Investigator Name
- Andrea Bauer
- Principal Investigator Email
- Andrea.Bauer@uniklinikum-dresden.de
- Contact Person Name
- Andrea Bauer
- Contact Person Email
- Andrea.Bauer@uniklinikum-dresden.de
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 09-06-2025
- Latest Decision Or Authorization Date
- 20-06-2025
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Alexandrovska University Hospital
- Department Name
- Department of immunopathology at the clinic of clinical allergology
- Principal Investigator Name
- Mariya Staevska
- Principal Investigator Email
- mariya.staevska@gmail.com
- Contact Person Name
- Mariya Staevska
- Contact Person Email
- mariya.staevska@gmail.com
- Site Name
- Diagnostics And Consultancy Center Sveti Georgi EOOD
- Principal Investigator Name
- Irida Vasileva
- Principal Investigator Email
- iridavasileva@gmail.com
- Contact Person Name
- Irida Vasileva
- Contact Person Email
- iridavasileva@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- Multiprofile emergency department, cabinet of allergology
- Principal Investigator Name
- Sonya Genova
- Principal Investigator Email
- sonya.genova@pirogov.bg
- Contact Person Name
- Sonya Genova
- Contact Person Email
- sonya.genova@pirogov.bg
- Site Name
- Medical Center Excelsior OOD
- Principal Investigator Name
- Todor Popov
- Principal Investigator Email
- ted.popov@gmail.com
- Contact Person Name
- Todor Popov
- Contact Person Email
- ted.popov@gmail.com
- Site Name
- Ambulatoria Za Individualna Praktika Za Specializirana Izvunbolnichna Medicinska Pomost Po Alergologia Doktor Talyat Sali Cholak EOOD
- Principal Investigator Name
- Talyat Sally Cholak
- Principal Investigator Email
- raz35doc@abv.bg
- Contact Person Name
- Talyat Sally Cholak
- Contact Person Email
- raz35doc@abv.bg
Italy
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 02-07-2025
- Processing Time Days
- 110
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Advanced Multidisciplinary Center Asthma, Food and Drug Allergies
- Principal Investigator Name
- Mona-Rita Yacoub
- Principal Investigator Email
- yacoub.monarita@hsr.it
- Contact Person Name
- Mona-Rita Yacoub
- Contact Person Email
- yacoub.monarita@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Marco Adriano Chessa
- Principal Investigator Email
- marcoadriano.chessa2@unibo.it
- Contact Person Name
- Marco Adriano Chessa
- Contact Person Email
- marcoadriano.chessa2@unibo.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Dermatology Clinic, Department of Medicine
- Principal Investigator Name
- Camilla Vassallo
- Principal Investigator Email
- c.vassallo@smatteo.pv.it
- Contact Person Name
- Camilla Vassallo
- Contact Person Email
- c.vassallo@smatteo.pv.it
Sponsor
Primary sponsor
- Full Name
- Evommune Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Premier Research Group S.L.
- Responsibilities
- Investigator Recruitment; Regulatory submissions; other listed duties (codes 1,10,11,12,13,15)
- Name
- Medpace Inc.
- Responsibilities
- Laboratory/clinical operations support (sponsorDuties code 4)
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- Support services (sponsorDuties code 14; contact fcsinfo@thermofisher.com)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic data capture/eClinical platform (sponsorDuties code 7)
Third parties
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 14; contact fcsinfo@thermofisher.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"Investigator Recruitment; Regulatory submissions; duties codes include 1,10,11,12,13,15 (as listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Gene By Gene Ltd.","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Pharmaron (Germantown) Lab Services Inc.","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"Laboratory/clinical operations support (sponsorDuties code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic data capture/eClinical platform (sponsorDuties code 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"Laboratory/testing (sponsorDuties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- EVO756 Potassium
- Active Substance
- EVO756 POTASSIUM
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1 (as per productDictionaryInfo)
- Maximum Dose
- 1 mg
Related trials
Other published trials that may interest you.