Clinical trial • Phase II • Dermatology|Immunology

BFB759 for Atopic dermatitis

Phase II trial of BFB759 for Atopic dermatitis. Randomised, placebo (placebo; active substance n/a; dose and schedule not specified in record)-controlled.

Overview

Trial Therapeutic Area
Dermatology|Immunology
Trial Disease
Atopic dermatitis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
15-07-2025
First CTIS Authorization Date
31-10-2025

Trial design

Randomised, placebo (placebo; active substance n/a; dose and schedule not specified in record)-controlled Phase II trial in Germany, Czechia, Bulgaria and others.

Randomised
Yes
Comparator
Placebo (Placebo; active substance N/A; dose and schedule not specified in record)
Target Sample Size
103

Eligibility

Recruits 103 adults.

Pregnancy Exclusion
Are pregnant or breastfeeding.

Inclusion criteria

  • {"criterion_text":"- Are adults (18 to 75 years) with a diagnosis of atopic dermatitis for at least one year."}
  • {"criterion_text":"- Have moderate to severe disease not well controlled by topical treatments."}
  • {"criterion_text":"- Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study."}

Exclusion criteria

  • {"criterion_text":"- Have certain infections or other immune conditions."}
  • {"criterion_text":"- Recently used medications that could interfere with the study."}
  • {"criterion_text":"- Are pregnant or breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change from baseline at Week 16 in EASI (Eczema Area and Severity Index) for Active 1 and Active 2 groups compared to Placebo","definition_or_measurement_approach":"Percent change from baseline in EASI score at Week 16 versus baseline for Active 1 and Active 2 groups compared to Placebo (EASI score assessed per standard EASI assessment)."}

Secondary endpoints

  • {"endpoint_text":"- Analysis (Active 1 and Active 2 compared to Placebo): Proportion of participants meeting criteria for EASI75 defined as at least a 75% decrease in EASI score at Week 16 relative to baseline","definition_or_measurement_approach":"Proportion of participants achieving ≥75% reduction in EASI score at Week 16 versus baseline."}
  • {"endpoint_text":"- Proportion of participants meeting criteria for EASI50 defined as at least a 50% decrease in EASI score at Week 16 relative to baseline","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction in EASI score at Week 16 versus baseline."}
  • {"endpoint_text":"- Proportion of participants meeting criteria for EASI90 defined as at least a 90% decrease in EASI score at Week 16 relative to baseline","definition_or_measurement_approach":"Proportion of participants achieving ≥90% reduction in EASI score at Week 16 versus baseline."}
  • {"endpoint_text":"- Changes from baseline in Body Surface Area (BSA) at Week 16","definition_or_measurement_approach":"Change from baseline in percent Body Surface Area affected at Week 16."}
  • {"endpoint_text":"- Changes from baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16","definition_or_measurement_approach":"Change from baseline in SCORAD score at Week 16."}
  • {"endpoint_text":"- Changes from baseline in the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16","definition_or_measurement_approach":"Change from baseline in vIGA-AD score at Week 16 (validated investigator global assessment)."}
  • {"endpoint_text":"- Proportion of participants meeting the criteria of a vIGA-AD response of 0 or 1 at Week 16 relative to baseline","definition_or_measurement_approach":"Proportion of participants with vIGA-AD score of 0 or 1 at Week 16 versus baseline."}
  • {"endpoint_text":"- Changes from baseline in the weekly average Itch Numerical Rating Scale (NRS) at Week 16","definition_or_measurement_approach":"Change from baseline in weekly average itch NRS score at Week 16."}
  • {"endpoint_text":"- Proportion of participants with ≥ 4-point decrease in weekly average Itch NRS in participants with a weekly average Itch NRS ≥ 4 at baseline at Week 16 relative to baseline","definition_or_measurement_approach":"Proportion of participants (with baseline weekly average itch NRS ≥4) achieving ≥4-point decrease in weekly average itch NRS at Week 16 versus baseline."}
  • {"endpoint_text":"- Safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events (TEAEs) (described by Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0)","definition_or_measurement_approach":"Incidence and severity of TEAEs graded per CTCAE v5.0."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
103
Recruitment Window Months
26
Consent Approach
Informed consent is obtained from adult participants (inclusion: adults 18 to 75 years). Subject information and informed consent forms (L1_PIS-ICF_Main) and pregnancy information forms (L1_PIS-ICF_Pregnancy) are provided and are available in country/language-specific versions (documents present for DE, CZ, BG, ES, PL; some English redacted versions present e.g. BG_eng). Emergency card and Scout (site) ICF documents are also included. Specific assent procedures are not described in the record.

Methods

  • K1_Recruit Statement — country-specific recruitment statement documents present for Germany, Czechia, Bulgaria, Spain, Poland (document titles listed in CTIS).
  • K2_Advertisement Document — advertisement materials (titles present per country: DE, CZ, BG, ES, PL).
  • K2_Clinago Website Landing Page — website landing page documents present (digital recruitment) per country.
  • K2_Doctor to Patient Letter — letters for clinicians to inform patients (present per country).
  • K2_Flyer / K2_Patient Brochure / K2_Bookmark / K2_Central Advertisement Document — printed/digital patient-facing materials available per country.
  • K2_Contact Script — contact scripts (likely for phone or outreach) available per country.
  • L2_Other Subject Material_Emergency card — subject cards provided (per country).

Geography

Total Number Of Sites
39
Total Number Of Participants
94

Germany

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
59
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Dermatology
Contact Person Name
Wiebke Sondermann
Contact Person Email
Wiebke.sondermann@uk-essen.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Dermatology
Contact Person Name
Timo Buhl
Site Name
Universitaet Muenster
Department Name
Dermatology
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Dermatology
Contact Person Name
Knut Schaekel
Site Name
CRS Clinical Research Services Management GmbH
Department Name
Dermatology
Contact Person Name
Denise Barry
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatology
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de

Czechia

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
56
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Dermatovenerologicka ordinace MUDr. Blanka Havlickova
Department Name
Dermatology and venerology
Contact Person Name
Blanka Havlickova
Contact Person Email
maposta@email.cz
Site Name
Clintrial s.r.o.
Department Name
Dermatology
Contact Person Name
Otakar Komarek
Contact Person Email
o.komarek@clintrial.cz
Site Name
Pratia Pardubice a.s.
Department Name
Klinické hodnocení
Contact Person Name
Andrea Bartlova
Contact Person Email
Andrea.bartlova@pratia.com
Site Name
CCR Ostrava s.r.o.
Department Name
Dermatology
Contact Person Name
Ondrej Haton
Contact Person Email
ondrej.haton@ccrostrava.com

Bulgaria

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
140
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Asclepius Medical Center OOD
Department Name
Dermatology
Contact Person Name
Boyka Stoyanova
Contact Person Email
Dr.boyka.stoyanova@gmail.com
Site Name
Medical Center Medconsult Burgas EOOD
Department Name
Dermatology
Contact Person Name
Karen Manuelyan
Contact Person Email
doc.manuelyan_mcburgas@abv.bg
Site Name
Medical Center Medconsult Pleven OOD
Department Name
Dermatology
Contact Person Name
Krasimira Vasileva
Contact Person Email
Vasileva_mclovech@abv.bg
Site Name
Medical Center Medconsult Pleven OOD (second site address)
Department Name
Dermatology
Contact Person Name
Kamelia Vekovska
Contact Person Email
Kvekovska_medconsult@abv.bg

Spain

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
143
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Dermatology
Contact Person Name
Juan Ruano Ruiz
Contact Person Email
juanruanoruiz@mac.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatology
Contact Person Name
Juan Francisco Silvestre-Salvador
Contact Person Email
silvestre_jfr@gva.es
Site Name
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Department Name
Dermatology
Contact Person Name
Álvaro Gonzalez Cantero
Contact Person Email
alvarogc261893@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Dermatology
Contact Person Name
Eduardo López Bran
Site Name
Hospital General De Granollers
Department Name
Dermatology
Contact Person Name
Antonio Guilabert Vidal
Contact Person Email
aguilabert@fphag.org
Site Name
Hospital (Cordoba) - site entry
Department Name
Dermatology

Poland

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
143
Number Of Sites
19
Number Of Participants
39

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Aleksandra Badzian
Site Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Anna Ankudowicz
Contact Person Email
kontakt@klinikabadawcza.pl
Site Name
Manufaktura Urody Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Piotr Sobolewski
Site Name
Dermedic Jacek Zdybski
Department Name
Dermatology
Contact Person Name
Piotr Parcheta
Contact Person Email
piotr.parcheta@zdybski.pl
Site Name
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Hubert Arasiewicz
Contact Person Email
badania-kliniczne@czdir.pl
Site Name
Synexus Polska Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Joanna Renczynska-Matysko
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Leszek Bartoszak
Contact Person Email
bartoszak@twojaprzychodnia.com
Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
Dermatology
Contact Person Name
Marta Wilkowska-Trojniel
Contact Person Email
lipska@clinicmed.pl
Site Name
Renew Clinic Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Hanna Mysliwiec
Contact Person Email
badania.koordynator@gmail.com
Site Name
Jagiellonskie Centrum Innowacji Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Magdalena Nastalek
Contact Person Email
koordynatorzy@jci.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
Dermatology
Contact Person Name
Weronika Chorążyczewska
Contact Person Email
kinga.kieronczyk@emc-sa.pl
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Department Name
Dermatology
Contact Person Name
Albert Gornicki
Contact Person Email
kermed@kermed.pl
Site Name
Prywatna Praktyka Lekarska Ewa Ring
Department Name
Dermatology
Contact Person Name
Ewa Ring
Contact Person Email
eringtrial@gmail.com
Site Name
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska
Department Name
Dermatology
Contact Person Name
Edyta Gebska
Contact Person Email
egebska@dermapolis.pl
Site Name
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
Department Name
Dermatology
Contact Person Name
Joanna Rudowska-Okrasko
Contact Person Email
ic@mcbk.pl
Site Name
Therapia Nova Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Ryszard Galus
Contact Person Email
Kontakt.therapianova@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Dermatology
Contact Person Name
Alina Jankowska-Konsur
Contact Person Email
gosiaponikowska@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
Dermatology
Contact Person Name
Beata Imko-Walczuk
Contact Person Email
pihouse@pihouse.pl

Sponsor

Primary sponsor

Full Name
Bluefin Biomedicine Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
code:4
Name
Innovaderm Research Inc.
Responsibilities
codes:1,11,12,13,2,5,9
Name
Argus Techsol
Responsibilities
Safety database; code:8
Name
Fisher Clinical Services GmbH
Responsibilities
code:14

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment rental","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training Platform","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Argus Techsol","duties_or_roles":"Safety database; code:8","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Innovaderm Research Inc.","duties_or_roles":"codes:1,11,12,13,2,5,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc. (CDMS support)","duties_or_roles":"eCOA; codes:3,7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Archemedx Inc.","duties_or_roles":"Training Platform","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Meal Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Quantificare SA","duties_or_roles":"Medical photography and image analysis","organisation_type":"Industry"}

Investigational products

Investigational Product Name
BFB759
Active Substance
BFB759
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Investigational Product Name
Placebo
Modality
Other

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