Clinical trial • Phase II • Dermatology
APG777 for Atopic dermatitis
Phase II trial of APG777 for Atopic dermatitis.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Atopic dermatitis
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 11-08-2025
Trial design
open-label, none/not specified (placebo is listed as a product but no comparator arms, doses or schedules are specified in the lte documentation)-controlled Phase II trial across 39 sites in Czechia, France, Hungary and others.
- Open Label
- Yes
- Comparator
- None/Not specified (Placebo is listed as a product but no comparator arms, doses or schedules are specified in the LTE documentation)
- Target Sample Size
- 271
- Trial Duration For Participant
- 1095
Eligibility
Recruits 271 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Inclusion criteria
- {"criterion_text":"- Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator’s opinion, compliant with the study protocol"}
- {"criterion_text":"- Participants who, in the Investigator’s opinion, would benefit from long-term treatment with APG777"}
- {"criterion_text":"- Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study"}
Exclusion criteria
- {"criterion_text":"- Participants who have developed an AE while participating in the Parent Study which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient"}
- {"criterion_text":"- Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study"}
- {"criterion_text":"- Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study"}
- {"criterion_text":"- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments"}
- {"criterion_text":"- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 3 years]","definition_or_measurement_approach":"Number of participants with treatment-emergent adverse events counted over a time frame up to 3 years."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Percent achieving EASI 50/75/90/100 calculated relative to Parent Study baseline over the extended treatment period (average 2 years)."}
- {"endpoint_text":"- Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline. [Time Frame: Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Percent achieving vIGA-AD 0 or 1 plus ≥2-point reduction versus Parent Study baseline over extended treatment (average 2 years)."}
- {"endpoint_text":"- Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Percent achieving ≥4-point improvement in weekly mean daily I-NRS versus Parent Study baseline over extended treatment (average 2 years)."}
- {"endpoint_text":"- Percentage of Participants who use Rescue Therapy [Time Frame: Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Percent of participants using rescue therapy during the extended treatment period (average 2 years)."}
- {"endpoint_text":"- Percentage of Participants Who Continue to Exhibit EASI 75 Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Among those achieving EASI 75 at Week 52 of the Parent Study, percent who continue to show EASI 75 from Week 52 through the extended treatment period (avg 2 years)."}
- {"endpoint_text":"- Percentage of Participants Who Continue to Exhibit vIGA-AD Response Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Among those achieving vIGA-AD response at Week 52 of the Parent Study, percent who continue to exhibit that response from Week 52 through the extended treatment period (avg 2 years)."}
- {"endpoint_text":"- Percentage of Participants Who Continue to Exhibit I-NRS Response Of the participants who achieve a ≥ 4-point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]","definition_or_measurement_approach":"Among those achieving ≥4-point I-NRS improvement at Week 52 of the Parent Study, percent who continue to exhibit that response from Week 52 through the extended treatment period (avg 2 years)."}
- {"endpoint_text":"- Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs [Time Frame: Up to 3 years]","definition_or_measurement_approach":"Count of participants discontinuing treatment due to treatment-related TEAEs and SAEs over up to 3 years."}
- {"endpoint_text":"- Serum Concentrations of APG777 Over Time [Time Frame: Up to 3 years]","definition_or_measurement_approach":"Serial measurement of serum APG777 concentrations over a time frame up to 3 years (PK monitoring)."}
- {"endpoint_text":"- Predose Serum Concentrations of APG777 [Time Frame: Up to 3 years]","definition_or_measurement_approach":"Measurement of predose (trough) serum concentrations of APG777 over up to 3 years."}
Recruitment
- Planned Sample Size
- 271
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent obtained via subject information sheets and informed consent forms (L1 SIS and ICF documents). Multiple language versions provided (Czech, French, Polish, German, Hungarian, Spanish, English). Consent is provided by participants; no paediatric assent or special vulnerable-population consent procedures are described in the available documents.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 175
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Sanatorium profesora Arenbergera
- Principal Investigator Name
- Petr Arenberger
- Principal Investigator Email
- avemedica@email.cz
- Contact Person Name
- Petr Arenberger
- Contact Person Email
- avemedica@email.cz
- Site Name
- Clintrial s.r.o.
- Principal Investigator Name
- Otakar Komárek
- Principal Investigator Email
- o.komarek@clintrial.cz
- Contact Person Name
- Otakar Komárek
- Contact Person Email
- o.komarek@clintrial.cz
- Site Name
- Kozni ambulance Fialova s.r.o.
- Principal Investigator Name
- Alena Fialová
- Principal Investigator Email
- alenka.fialova@seznam.cz
- Contact Person Name
- Alena Fialová
- Contact Person Email
- alenka.fialova@seznam.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Dermatovenerologické oddělení
- Principal Investigator Name
- Alena Machovcová
- Principal Investigator Email
- alena.machovcova@fnmotol.cz
- Contact Person Name
- Alena Machovcová
- Contact Person Email
- alena.machovcova@fnmotol.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Dermatovenerologická klinika
- Principal Investigator Name
- Spyridon Gkalpakiotis
- Principal Investigator Email
- spyridon.gkalpakiotis@fnkv.cz
- Contact Person Name
- Spyridon Gkalpakiotis
- Contact Person Email
- spyridon.gkalpakiotis@fnkv.cz
France
- Earliest CTIS Part Ii Submission Date
- 02-12-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 36
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Du Docteur Ruer S.E.L.A.R.L.
- Department Name
- Dermatologie
- Principal Investigator Name
- Mireille RUER-MULARD
- Principal Investigator Email
- ruerdoc@gmail.com
- Contact Person Name
- Mireille RUER-MULARD
- Contact Person Email
- ruerdoc@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 36
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Semmelweis University
- Department Name
- Dermatology, Venerology and Dermatooncology
- Principal Investigator Name
- Péter Holló
- Principal Investigator Email
- hollo.peter@semmelweis.hu
- Contact Person Name
- Péter Holló
- Contact Person Email
- hollo.peter@semmelweis.hu
- Site Name
- University Of Debrecen
- Department Name
- Department of 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
- University Of Szeged
- Department Name
- Albert Szent-Györgyi Health Center, Department of Dermatology and Allergology
- Principal Investigator Name
- Rolland Gyulai
- Principal Investigator Email
- pi.gyulai@szte.hu
- Contact Person Name
- Rolland Gyulai
- Contact Person Email
- pi.gyulai@szte.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 11-07-2025
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 216
- Number Of Sites
- 11
- Number Of Participants
- 82
Sites
- Site Name
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Principal Investigator Name
- Wioletta Laszczewska
- Principal Investigator Email
- w.laszczewska@ctw.com.p
- Contact Person Name
- Wioletta Laszczewska
- Contact Person Email
- w.laszczewska@ctw.com.p
- Site Name
- Dermmedica Sp. z o.o.
- Principal Investigator Name
- Jolanta Weglowska
- Principal Investigator Email
- office@dermmedica.pl
- Contact Person Name
- Jolanta Weglowska
- Contact Person Email
- office@dermmedica.pl
- Site Name
- Dermaceum Sp. z o.o.
- Department Name
- DERMACEUM CENTRUM MEDYCZNE
- Principal Investigator Name
- Michal Torz
- Principal Investigator Email
- kontakt@dermaceum.pl
- Contact Person Name
- Michal Torz
- Contact Person Email
- kontakt@dermaceum.pl
- Site Name
- Prywatna Praktyka Lekarska Ewa Ring (Dermasters)
- Principal Investigator Name
- Ewa Ring
- Principal Investigator Email
- eringtrial@gmail.com
- Contact Person Name
- Ewa Ring
- Contact Person Email
- eringtrial@gmail.com
- Site Name
- Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
- Principal Investigator Name
- Hubert Arasiewicz
- Principal Investigator Email
- badania-kliniczne@czdir.pl
- Contact Person Name
- Hubert Arasiewicz
- Contact Person Email
- badania-kliniczne@czdir.pl
- Site Name
- Gyncentrum Sp. z o.o.
- Department Name
- NZOZ Holsamed - Oddzial Libero
- 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
- Therapia Nova Sp. z o.o.
- Principal Investigator Name
- Ryszard Galus
- Principal Investigator Email
- kontakt.therapianova@gmail.com
- Contact Person Name
- Ryszard Galus
- Contact Person Email
- kontakt.therapianova@gmail.com
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Dorota Kolodziejczyk
- Principal Investigator Email
- biuro.mcm@pratia.com
- Contact Person Name
- Dorota Kolodziejczyk
- Contact Person Email
- biuro.mcm@pratia.com
- Site Name
- LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
- Principal Investigator Name
- Dorota Krasowska
- Principal Investigator Email
- gabinetluxderm@gmail.com
- Contact Person Name
- Dorota Krasowska
- Contact Person Email
- gabinetluxderm@gmail.com
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Beata Imko-Walczuk
- Principal Investigator Email
- pihouse@pihouse.pl
- Contact Person Name
- Beata Imko-Walczuk
- Contact Person Email
- pihouse@pihouse.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia SCM
- Principal Investigator Name
- Tadeusz Debniak
- Principal Investigator Email
- debniak@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Debniak
- Contact Person Email
- debniak@twojaprzychodnia.com
Germany
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 63
- Number Of Sites
- 14
- Number Of Participants
- 44
Sites
- Site Name
- Rosenpark Research GmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Oliver Weirich
- Principal Investigator Email
- oliver.weirich@rosenparkresearch.de
- Contact Person Name
- Oliver Weirich
- Contact Person Email
- oliver.weirich@rosenparkresearch.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitaets-Hautklinik Tuebingen
- Principal Investigator Name
- Sebastian Volc
- Principal Investigator Email
- sebastian.volc@med.uni-tuebingen.de
- Contact Person Name
- Sebastian Volc
- Contact Person Email
- sebastian.volc@med.uni-tuebingen.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik fuer Dermatologie und Venerologie
- Principal Investigator Name
- Kilian Eyerich
- Principal Investigator Email
- kilian.eyerich@uniklinik-freiburg.de
- Contact Person Name
- Kilian Eyerich
- Contact Person Email
- kilian.eyerich@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
- Department Name
- Institut fuer Entzuendungsmedizin
- Principal Investigator Name
- Diamant Thaci
- Principal Investigator Email
- diamant.thaci@uksh.de
- Contact Person Name
- Diamant Thaci
- Contact Person Email
- diamant.thaci@uksh.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
- Department Name
- Center for Inflammatory Skin Diseases, Dept. of Dermatology, Venereology and Allergology
- Principal Investigator Name
- Sascha Gerdes
- Principal Investigator Email
- sgerdes@dermatology.uni-kiel.de
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Klinik fuer Dermatologie, Venerologie und Allergologie
- 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
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik fuer Dermatologie
- Principal Investigator Name
- Roland Aschoff
- Principal Investigator Email
- roland.aschoff@ukdd.de
- Contact Person Name
- Roland Aschoff
- Contact Person Email
- roland.aschoff@ukdd.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Hautklinik
- Principal Investigator Name
- Knut Schaekel
- Principal Investigator Email
- knut.schaekel@med.uni-heidelberg.de
- Contact Person Name
- Knut Schaekel
- Contact Person Email
- knut.schaekel@med.uni-heidelberg.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik fuer Hautkrankheiten
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- nina.magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- nina.magnolo@ukmuenster.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie Abteilung Allergologie und Immunologie
- Principal Investigator Name
- Margitta Worm
- Principal Investigator Email
- margitta.worm@charite.de
- Contact Person Name
- Margitta Worm
- Contact Person Email
- margitta.worm@charite.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Klinik fuer Dermatologie
- Principal Investigator Name
- Andreas Wollenberg
- Principal Investigator Email
- andreas.wollenberg@uk-augsburg.de
- Contact Person Name
- Andreas Wollenberg
- Contact Person Email
- andreas.wollenberg@uk-augsburg.de
- Site Name
- Dermatologikum Hamburg GmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Peter Weisenseel
- Principal Investigator Email
- p.weisenseel@dermatologikum.de
- Contact Person Name
- Peter Weisenseel
- Contact Person Email
- p.weisenseel@dermatologikum.de
- Site Name
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Department Name
- +4933792062976
- Principal Investigator Name
- Michael Sebastian
- Principal Investigator Email
- m.sebastian@derma-mahlow.de
- Contact Person Name
- Michael Sebastian
- Contact Person Email
- m.sebastian@derma-mahlow.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Klinik und Poliklinik fuer Dermatologie und Allergologie
- Principal Investigator Name
- Felix Lauffer
- Principal Investigator Email
- felix.lauffer@med.uni-muenchen.de
- Contact Person Name
- Felix Lauffer
- Contact Person Email
- felix.lauffer@med.uni-muenchen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 18-12-2025
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 109
- Number Of Sites
- 5
- Number Of Participants
- 23
Sites
- Site Name
- Icr Medical S.L.
- Department Name
- Dermatología
- Principal Investigator Name
- Álvaro Gonzalez Cantero
- Principal Investigator Email
- alvaro.gonzalez@icmrresearch.com
- Contact Person Name
- Álvaro Gonzalez Cantero
- Contact Person Email
- alvaro.gonzalez@icmrresearch.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatología
- Principal Investigator Name
- María Ángeles Florez Menendez
- Principal Investigator Email
- angeles.florez.menendez@sergas.es
- Contact Person Name
- María Ángeles Florez Menendez
- Contact Person Email
- angeles.florez.menendez@sergas.es
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Dermatología
- Principal Investigator Name
- Alicia Lourdes Gonzalez Quesada
- Principal Investigator Email
- ali_gq@hotmail.com
- Contact Person Name
- Alicia Lourdes Gonzalez Quesada
- Contact Person Email
- ali_gq@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Dermatología
- Principal Investigator Name
- Jose Manuel Carrascosa Carrillo
- Principal Investigator Email
- eserra@santpau.cat
- Contact Person Name
- Jose Manuel Carrascosa Carrillo
- Contact Person Email
- eserra@santpau.cat
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Dermatología
- Principal Investigator Name
- Juan Francisco Silvestre Salvador
- Principal Investigator Email
- silvestre.jfr@gmail.com
- Contact Person Name
- Juan Francisco Silvestre Salvador
- Contact Person Email
- silvestre.jfr@gmail.com
Sponsor
Primary sponsor
- Full Name
- Apogee Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Name
- Syneos Health Clinique Inc.
- Name
- Veranex Inc.
- Name
- Labcorp Central Laboratory Services SARL
- Name
- Medidata Solutions Inc.
- Name
- Veeva Systems Inc.
- Responsibilities
- Trial Master File
- Name
- WCG Clinical Inc.
- Responsibilities
- Rater Training
- Name
- Scout Clinical
- Responsibilities
- Investigator Meeting, Patient Travel and Reimbursement
- Name
- Suvoda LLC
- Responsibilities
- eCOA
- Name
- Fisher Clinical Services Inc.
Third parties
- {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment rental","organisation_type":"Industry"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Trial Master File","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Investigator Meeting, Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Rater Training","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- APG777
- Active Substance
- APG777
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Investigational Product Name
- Placebo
- Modality
- Other
Related trials
Other published trials that may interest you.