Clinical trial • Phase IV • Dermatology

GALVOKIMIG for Atopic dermatitis

Phase IV trial of GALVOKIMIG for Atopic dermatitis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Atopic dermatitis
Trial Stage
Phase IV
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
04-11-2025
First CTIS Authorization Date
09-03-2026

Trial design

Randomised, placebo matching test 0.9% sodium chloride solution for injection (placebo); dose/schedule not specified in provided documents-controlled Phase IV trial across 40 sites in Bulgaria, Czechia, Germany and others.

Randomised
Yes
Comparator
Placebo matching Test 0.9% sodium chloride solution for injection (placebo); dose/schedule not specified in provided documents
Target Sample Size
72
Trial Duration For Participant
112

Eligibility

Recruits 72 Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be aged ≥18 and provide written informed consent; subject information and informed consent forms (ICF) are provided (multiple country/language versions present). Assent is not applicable because minors are excluded..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be aged ≥18 and provide written informed consent; subject information and informed consent forms (ICF) are provided (multiple country/language versions present). Assent is not applicable because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent\n- Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form [ICF]) and with: a. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline b. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline c. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline d. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline e. Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy"}

Exclusion criteria

  • {"criterion_text":"- Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant’s ability to participate in this study\n- Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis\n- Presence or family history (first degree) of inflammatory bowel disease (includes Crohn’s disease and ulcerative colitis)\n- History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator\n- Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria\n- Previous treatment with galvokimig\n- Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment\n- All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline\n- Treatment with biologic agents must discontinued at least 3 months prior to baseline"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16","definition_or_measurement_approach":"Proportion of participants achieving EASI75 (Eczema Area and Severity Index 75 response) at Week 16 compared with baseline (i.e., percentage of participants with ≥75% improvement in EASI at Week 16)."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16","definition_or_measurement_approach":"Proportion of participants achieving a validated Investigator Global Assessment (vIGA) response at Week 16 (as defined by the study vIGA criteria)."}
  • {"endpoint_text":"- Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16","definition_or_measurement_approach":"Change from baseline to Week 16 in the weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) score."}
  • {"endpoint_text":"- Incidence of Treatment-Emergent (TE) Adverse Events (AE)","definition_or_measurement_approach":"Incidence (frequency) of adverse events emerging during treatment (TEAEs) captured during the study period."}
  • {"endpoint_text":"- Incidence of TE Serious Adverse Events (SAEs)","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent serious adverse events (SAEs) captured during the study period."}

Recruitment

Registry Or Advocacy Recruitment
True, Center For Information And Study On Clinical Research Participation Inc.
Digital Remote Recruitment
True, use of social media campaigns, website/webscreen recruitment pages, digital graphics for stories/posts, online referral materials, and electronic clinical outcome capture (eCOA/ePRO) services provided by third parties
Planned Sample Size
92
Recruitment Window Months
22
Consent Approach
Written informed consent is required from each participant (all participants must be ≥18). Subject information and ICF documents are provided (multiple country/language versions present: English/generic public, Bulgarian (BG), Czech (CS), German (DE), Hungarian (HU), Polish (PL)). Specific ICFs for pregnancy and for genetic research/optional future research are available where indicated.

Methods

  • Poland: brochures, posters, website screens/web adverts, social media graphics and stories, recruitment web content, text for posts and graphic assets (documents: K2_45001-PL-Zakrzewski-Brochure, K2_PL-recruitment-poster, K2_45001-PL-Zakrzewski-graphicforstories, K2_45001_PL_Zakrzewski_textforpost, K2_45001_PL_Zakrzewski_textwebsite)
  • Hungary: brochures, study posters, social media, webscreen recruitment pages (documents: K2_HU-recruit-brochure, K2_HU-recruit-studyposter, K2_HU-recruit-Social_Media, K2_HU-recruitment-webscreen)
  • Czechia: brochures, posters, websitescreen, media awareness materials, referral materials (documents: K2_CZ-recruitment-brochure, K2_CZ-recruitment-poster, K2_CZ-recruitment-websitescreen, K2_CZ-recruit-process-ATD002, K2_CZ-recruitment-mediaawareness)
  • Bulgaria: brochures, posters, webscreen, advocacy and media recruitment materials, referral slides (documents: K2_BG-recruitment-brochure, K2_BG-recruitment-poster, K2_BG-recruitment-webscreen, K2_BG-recruitment-advocacy, K2_BG-recruitment-media)
  • Germany: recruitment posters, factsheets, webscreen, referral slide decks and media materials (documents: K2_DE-recruitment-poster, K2_DE-recruitment-factsheet, K1_DE-recruit-proced-descr, K2_DE-recruitment-webscreen)
  • Use of patient advocacy materials and referral slide decks across multiple countries (documents labelled "recruitment-advocacy" and "ReferralSlideDeck")
  • Digital eCOA/ePRO platforms for remote data capture (third-party eCOA/ePRO vendor listed)

Geography

Total Number Of Sites
40
Total Number Of Participants
92

Bulgaria

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
9
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Medical Center Medconsult Pleven OOD
Department Name
41001
Contact Person Name
Kamelia Vekovska
Contact Person Email
kvekovska_medconsult@abv.bg
Site Name
Medical Center Hera EOOD
Department Name
41005
Contact Person Name
Maria Ratkova
Contact Person Email
maria.ratkova@heraclinics.com
Site Name
Dkc Fokus-5 Lzip OOD
Department Name
41006
Contact Person Name
Grisha Mateev
Contact Person Email
grisha_mateev@yahoo.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
41004
Contact Person Name
Krasimira Vasileva
Contact Person Email
vasileva_mclovech@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
41007:Clinic of dermatology and venereology diseases
Contact Person Name
Teodor Aleksiev
Contact Person Email
dr.teodor.aleksiev@gmail.com
Site Name
Military Medical Academy
Department Name
41003: Clinic of dermatology, venereology and allergology
Contact Person Name
Vessel Kantardjiev
Contact Person Email
v.kantarjiev@vma.bg
Site Name
UNIMED Medical Center EOOD
Department Name
41002
Contact Person Name
Marina Sankeva
Contact Person Email
dr_sankeva@abv.bg
Site Name
Medical Center Medconsult Pleven OOD
Department Name
41001
Contact Person Name
Kamelia Vekovska
Contact Person Email
kvekovska_medconsult@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
6
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Kozni ambulance Fialova s.r.o.
Department Name
42004: Dermatologie / Dermatology
Contact Person Name
Alena Fialová
Site Name
Dermatovenerologicka ordinace MUDr. Blanka Havlickova, PhD.
Department Name
42007
Contact Person Name
Blanka Havlíčková
Contact Person Email
maposta@email.cz
Site Name
Clintrial s.r.o.
Department Name
42005: Dermatologie / Dermatology
Contact Person Name
Otakar Komárek
Contact Person Email
o.komarek@clintrial.cz
Site Name
Dermamedica s.r.o.
Department Name
42002
Contact Person Name
Romana Macháčková
Contact Person Email
romana.machackova@seznam.cz
Site Name
Praglandia s.r.o.
Department Name
42001
Contact Person Name
Tereza Sýkorová
Contact Person Email
t.sykor@praglandia.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
42003: Dermatovenerologická klinika / Dermatovenerological clinic
Contact Person Name
Filip Rob
Contact Person Email
filip.rob@bulovka.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
42006: Kožní oddělení / Department of Dermatology
Contact Person Name
Yvetta Vantuchová
Contact Person Email
Yvetta.vantuchova@fno.cz
Site Name
Clintrial s.r.o.
Department Name
42005: Dermatologie / Dermatology
Contact Person Name
Otakar Komárek
Contact Person Email
o.komarek@clintrial.cz

Germany

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
22
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Technische Universitaet Dresden
Department Name
43005: Klinik und Poliklinik für Dermatologie
Contact Person Name
Roland ASCHOFF
Contact Person Email
roland.aschoff@ukdd.de
Site Name
Universitaet Leipzig
Department Name
43004: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Jan Christoph SIMON
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Lübeck campus)
Department Name
43003: Campus Lübeck, Institut für Entzündungsmedizin
Contact Person Name
Diamant THACI
Contact Person Email
Diamant.Thaci@uksh.de
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Department Name
43007
Contact Person Name
Michael SEBASTIAN
Contact Person Email
m.sebastian@derma-mahlow.de
Site Name
Goethe University Frankfurt
Department Name
43002: Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas PINTER
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel campus)
Department Name
43006: Campus Kiel, Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Stephan WEIDINGER
Contact Person Email
stephan.weidinger@uksh.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
43001: Fachklinik Bad Bentheim Klinisches Studienzentrum
Contact Person Name
Athanasios TSIANAKAS
Contact Person Email
A.Tsianakas@fk-bentheim.de

Hungary

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
8
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
University Of Debrecen
Department Name
44001: Clinical Centre, Clinics of Dermatology
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.uni-deb.hu
Site Name
University Of Pecs
Department Name
44002 :Clinical Centre, Clinics of Dermatology, Venerology and Oncodermatology
Contact Person Name
Adriana Csernus
Contact Person Email
csernus.adriana@pte.hu
Site Name
Clinexpert Kft.
Department Name
44003
Contact Person Name
Dorottya Asboth
Contact Person Email
dr.asboth.dorottya@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
9
Number Of Sites
14
Number Of Participants
43

Sites

Site Name
Diamond Clinic Sp. z o.o.
Department Name
#45007: Diamond Medical Center
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu
Site Name
Santa Sp. z o.o.
Department Name
#45013: Santa Familia PTG Łódź
Contact Person Name
Cezary Chwała
Contact Person Email
cezary.chwala@ptg-network.com
Site Name
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Department Name
#45005: CENTRUM ZDROWIA DZIECKA I RODZINY IM. JANA PAWŁA II W SOSNOWCU - OŚRODEK BADAŃ KLINICZNYCH
Contact Person Name
Hubert Arasiewicz
Contact Person Email
Badania-kliniczne@czdir.pl
Site Name
Gyncentrum Sp. z o.o.
Department Name
#45001: NZOZ Holsamed- Oddzial Libero
Contact Person Name
Marcin Zakrzewski
Site Name
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
Department Name
#45011:SPECJALISTYCZNA PRAKTYKA LEKARSKA GABINET DERMATOLOGICZNY DR N. MED. EDYTA GĘBSKA
Contact Person Name
Edyta Gębska
Contact Person Email
biuro@dermapolis.pl
Site Name
Dermedic Iwona Zdybska
Department Name
#45012:NZOZ Dermedic
Contact Person Name
Joanna Nowak-Guzowska
Contact Person Email
joanna.nowak@zdybski.pl
Site Name
Dermaceum Sp. z o.o.
Department Name
#45008:DERMACEUM Centrum Medyczne
Contact Person Name
Michal Torz
Contact Person Email
m.torz@dermaceum.pl
Site Name
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Department Name
#45009
Contact Person Name
Bernadetta Majorek-Olechowska
Contact Person Email
bernadettaolechowska@gmail.com
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
#45014
Contact Person Name
Grazyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
#45002: Klinika Ambroziak Dermatologia
Contact Person Name
Monika Kałowska
Contact Person Email
michal@klinikaambroziak.pl
Site Name
Etg Warszawa Sp. z o.o.
Department Name
#45006: ETG Warszawa
Contact Person Name
Maria Zegadło-Mylik
Contact Person Email
m.zegadlomylik@etg-network.com
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
#45004:Niepubliczny Zaklad Opieki Zdrowotnej "DERMED" Centrum Medyczne
Contact Person Name
Aleksandra Kaszuba
Contact Person Email
akaszuba@op.pl
Site Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Department Name
#45010
Contact Person Name
Malgorzata Dyczek
Site Name
Pratia S.A.
Department Name
#45003: Pratia MCM Kraków
Contact Person Name
Dorota Kołodziejczyk
Contact Person Email
biuro.mcm@pratia.com

Sponsor

Primary sponsor

Full Name
UCB Biopharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
code: 4
Name
Icon Clinical Research Limited
Responsibilities
codes: 1,5,6
Name
Pharmaceutical Research Associates Group B.V.
Responsibilities
code: 4
Name
4G Clinical B.V.
Responsibilities
code: 3

Third parties

  • {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment supply","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA/ePRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Patient Reimbursment/Concierge Service","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"advocacy / patient information (code: 11)","organisation_type":"Patient organisation/association"}
  • {"country":"France","full_name":"Quantificare","duties_or_roles":"Photography","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Clinical Services International Limited","duties_or_roles":"Rescue medication supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Galvokimig
Active Substance
GALVOKIMIG
Modality
Bispecific antibody
Routes Of Administration
Subcutaneous (SUBCUTANEOUS USE)
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Placebo matching Test 0.9% sodium chloride solution for injection
Modality
Other

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