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
- 03-05-2024
- First CTIS Authorization Date
- 12-08-2024
Trial design
Randomised, placebo comparator: matching placebo subcutaneous injection per protocol defined dosing regimen (matching placebo injections per protocol). dose/schedule: per protocol-defined dosing regimen (not specified in the ctis record).-controlled Phase II trial in Poland, Germany, France and others.
- Randomised
- Yes
- Comparator
- Placebo Comparator: Matching placebo subcutaneous injection per protocol defined dosing regimen (matching placebo injections per protocol). Dose/schedule: per protocol-defined dosing regimen (not specified in the CTIS record).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 268
- Trial Duration For Participant
- 742
Eligibility
Recruits 268 No vulnerable populations selected; the trial population is adult patients. Informed consent is obtained from participants; no assent/parental consent procedures for minors are described..
- Vulnerable Population
- No vulnerable populations selected; the trial population is adult patients. Informed consent is obtained from participants; no assent/parental consent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- • Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit"}
- {"criterion_text":"- • Moderate-to-severe AD at Screening and Baseline visits"}
- {"criterion_text":"- • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable"}
- {"criterion_text":"- • Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits"}
- {"criterion_text":"- • Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit"}
Exclusion criteria
- {"criterion_text":"- • Participation in a prior study with APG777"}
- {"criterion_text":"- • Prior treatment with protocol-specified monoclonal antibodies (mAbs)"}
- {"criterion_text":"- • Has used any AD-related topical medications within 7 days prior to Baseline visit"}
- {"criterion_text":"- • Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16]","definition_or_measurement_approach":"Percent change from baseline in Eczema Area and Severity Index (EASI); Time Frame: Baseline and at Week 16."}
- {"endpoint_text":"- Part B: Proportion of patients who achieve EASI 75 at Week 16","definition_or_measurement_approach":"Proportion of patients achieving EASI 75 (≥75% improvement in EASI) at Week 16; Time Frame: Week 16."}
Secondary endpoints
- {"endpoint_text":"- Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks]","definition_or_measurement_approach":"Count of participants with treatment-emergent adverse events (TEAEs); Time Frame: up to 106 weeks of follow-up."}
- {"endpoint_text":"- Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52]","definition_or_measurement_approach":"Absolute change from baseline in EASI score measured at scheduled visits through Week 16 and at Week 52."}
- {"endpoint_text":"- Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Percent change from baseline in EASI measured through Week 16 and at Week 52."}
- {"endpoint_text":"- Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Proportion of participants achieving EASI 50/75/90/100 responses over time; Time Frame: baseline through Week 16 and at Week 52."}
- {"endpoint_text":"- Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0 or 1 with ≥2-point reduction versus baseline; Time Frame: baseline through Week 16 and at Week 52."}
- {"endpoint_text":"- Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Change from baseline in Body Surface Area (BSA) involvement; Time Frame: baseline through Week 16 and at Week 52."}
- {"endpoint_text":"- Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Proportion achieving ≥4-point improvement in weekly mean daily Itch NRS (I-NRS); Time Frame: baseline through Week 16 and at Week 52."}
- {"endpoint_text":"- Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through Week 16 and at Week 52]","definition_or_measurement_approach":"Percent change from baseline in weekly mean daily I-NRS; Time Frame: baseline through Week 16 and at Week 52."}
- {"endpoint_text":"- Serum Concentrations of APG777 Over Time [Time Frame: Up to 106 Weeks]","definition_or_measurement_approach":"Measurement of serum APG777 concentrations at scheduled PK time points up to 106 weeks."}
- {"endpoint_text":"- Predose Serum Concentrations of APG777 (Ctrough) [Time Frame: Up to 106 Weeks]","definition_or_measurement_approach":"Predose (trough) serum concentrations of APG777 measured at specified visits up to 106 weeks."}
- {"endpoint_text":"- Maximum concentration (Cmax) of APG777 [Time Frame: Up to 106 Weeks]","definition_or_measurement_approach":"Maximum observed serum concentration (Cmax) of APG777 at PK sampling time points up to 106 weeks."}
- {"endpoint_text":"- Time to reach Cmax (tmax) [Time Frame: Up to 106 Weeks]","definition_or_measurement_approach":"Time to observed Cmax (tmax) from dosing; Time Frame: up to 106 weeks."}
- {"endpoint_text":"- Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period [Time Frame: Baseline to 16 Weeks]","definition_or_measurement_approach":"AUC0-t during induction period (baseline to 16 weeks) derived from PK sampling."}
- {"endpoint_text":"- AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period [Time Frame: 16 Weeks to 52 Weeks]","definition_or_measurement_approach":"AUC over dosing interval (AUC0-tau) during maintenance period (16–52 weeks) derived from PK sampling."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 268
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent is obtained from each participant (adult participants). Multiple language subject information sheets and ICFs are provided (English, Polish, French, Czech, German, Hungarian, Spanish versions are present in the public documents). Pregnancy-specific information/ICF documents are included. Consent is provided by the participant; no assent/parental consent for minors is described.
Methods
- K2_Patient Brochure / Patient brochure (printed) – targeted to potential participants (country-specific brochures present across MSCs).
- K2_Patient Flyer – printed flyer for patients (country versions present).
- K2_Physician to Patient Letter – letters from physicians to patients to inform about the study.
- K2_Physician to Physician Letter – letters to referring physicians to inform about the study and recruitment.
- K2_Online_Prescreener – online pre-screening questionnaire for prospective participants (digital channel).
- K2_Patient_Website (including GDPR section) – study website for potential participants with information and contact.
- K2_Advertisement Document / Banner_Advertisement – digital banner advertisements for recruitment.
- K2_Advertising Instagram Post / Instagram ads / Instagram story – social media recruitment via Instagram (ads/posts/stories).
- K2_Banner_Advertisement – web banner ads for recruitment.
- Scout Clinical / Scout recruitment materials – vendor-managed recruitment including email communications and travel/meal reimbursement information (country-specific Scout materials present).
- K2_Patient_FAQ and Online materials – online FAQs and website content to support recruitment and pre-screening.
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 163
Poland
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 19-09-2025
- Processing Time Days
- 436
- Number Of Sites
- 11
- Number Of Participants
- 84
Sites
- Site Name
- Pratia S.A.
- Department Name
- Dermatology
- Principal Investigator Name
- Dorota Kołodziejczyk
- Principal Investigator Email
- dkolodziejczyk@partia.pl
- Contact Person Name
- Dorota Kołodziejczyk
- Contact Person Email
- dkolodziejczyk@partia.pl
- Site Name
- Therapia Nova Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Ryszard Galus
- Principal Investigator Email
- galusmed@gmail.com
- Contact Person Name
- Ryszard Galus
- Contact Person Email
- galusmed@gmail.com
- Site Name
- Dermmedica Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Jolanta Węgłowska
- Principal Investigator Email
- jolaweglowska@tlen.pl
- Contact Person Name
- Jolanta Węgłowska
- Contact Person Email
- jolaweglowska@tlen.pl
- Site Name
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Department Name
- Dermatology
- Principal Investigator Name
- Elżbieta Królikowska
- Principal Investigator Email
- e.krolikowska@ctw.com.pl
- Contact Person Name
- Elżbieta Królikowska
- Contact Person Email
- e.krolikowska@ctw.com.pl
- Site Name
- Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
- Department Name
- Dermatology
- 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
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Tadeusz Dębniak
- Principal Investigator Email
- debniak@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Dębniak
- Contact Person Email
- debniak@twojaprzychodnia.com
- Site Name
- Gyncentrum Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Marcin Zakrzewski
- Principal Investigator Email
- m.zakrzewski@gyncentrum.pl
- Contact Person Name
- Marcin Zakrzewski
- Contact Person Email
- m.zakrzewski@gyncentrum.pl
- Site Name
- Dermaceum Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Michał Torz
- Principal Investigator Email
- m.torz@dermaceum.pl
- Contact Person Name
- Michał Torz
- Contact Person Email
- m.torz@dermaceum.pl
- Site Name
- Prywatna Praktyka Lekarska Ewa Ring
- Department Name
- Dermatology
- 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 Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Beata Imko-Walczuk
- Principal Investigator Email
- w.szyszkowski@pihouse.pl
- Contact Person Name
- Beata Imko-Walczuk
- Contact Person Email
- w.szyszkowski@pihouse.pl
- Site Name
- Luxderm Specjalistyczny Gabinet Dermatologiczny
- Department Name
- Dermatology
- Principal Investigator Name
- Dorota Krasowska
- Principal Investigator Email
- dor.krasowska@gmail.com
- Contact Person Name
- Dorota Krasowska
- Contact Person Email
- dor.krasowska@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 26-09-2024
- Latest Decision Or Authorization Date
- 26-09-2025
- Processing Time Days
- 365
- Number Of Sites
- 16
- Number Of Participants
- 40
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
- Department Name
- Dermatology
- Principal Investigator Name
- Diamant Thaçi
- Principal Investigator Email
- diamant.thaci@uksh.de
- Contact Person Name
- Diamant Thaçi
- Contact Person Email
- diamant.thaci@uksh.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Dermatology
- 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
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Department Name
- Dermatology
- 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
- Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
- Department Name
- Dermatology
- 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
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Dermatology, Venerology
- 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
- 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
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Dermatology
- 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
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Dermatology
- 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
- University Medical Center Hamburg-Eppendorf
- Department Name
- Dermatology
- Principal Investigator Name
- Matthias Augustin
- Principal Investigator Email
- m.augustin@uke.de
- Contact Person Name
- Matthias Augustin
- Contact Person Email
- m.augustin@uke.de
- Site Name
- Universitaet Muenster
- Department Name
- Dermatology
- 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
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Dermatology
- Principal Investigator Name
- Knut Schaekel
- Principal Investigator Email
- StudienSchaekel.haut@med.uni-heidelberg.de
- Contact Person Name
- Knut Schaekel
- Contact Person Email
- StudienSchaekel.haut@med.uni-heidelberg.de
- 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 Frankfurt AöR
- Department Name
- Dermatology
- 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
- Dermatology
- 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 Tuebingen AöR
- Department Name
- Dermatology
- 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
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
France
- Earliest CTIS Part Ii Submission Date
- 04-10-2024
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 346
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Dermatology
- Principal Investigator Name
- Anne-Bénédicte Duval-Modeste
- Principal Investigator Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Contact Person Name
- Anne-Bénédicte Duval-Modeste
- Contact Person Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Dermatology
- Principal Investigator Name
- Sébastien Barbarot
- Principal Investigator Email
- sebastien.barbarot@chu-nantes.fr
- Contact Person Name
- Sébastien Barbarot
- Contact Person Email
- sebastien.barbarot@chu-nantes.fr
- Site Name
- Du Docteur Ruer S.E.L.A.R.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Mireille Ruer
- Principal Investigator Email
- ruerdoc@gmail.com
- Contact Person Name
- Mireille Ruer
- Contact Person Email
- ruerdoc@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 17-09-2025
- Processing Time Days
- 335
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Dermatovenerology
- 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
- Clintrial s.r.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Otakar Komarek
- Principal Investigator Email
- o.komarek@clintrial.cz
- Contact Person Name
- Otakar Komarek
- Contact Person Email
- o.komarek@clintrial.cz
- Site Name
- Sanatorium profesora Arenbergera
- Department Name
- Dermatovenerology
- Principal Investigator Name
- Petr Arenberger
- Principal Investigator Email
- avemedica@email.cz
- Contact Person Name
- Petr Arenberger
- Contact Person Email
- avemedica@email.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Dermatovenerology
- Principal Investigator Name
- Spyridon Gkalpakiotis
- Principal Investigator Email
- Spyridon.Gkalpakiotis@fnkv.cz
- Contact Person Name
- Spyridon Gkalpakiotis
- Contact Person Email
- Spyridon.Gkalpakiotis@fnkv.cz
- Site Name
- Kozni ambulance Fialova s.r.o.
- Department Name
- Dermatovenerology
- Principal Investigator Name
- Alena Fialová
- Principal Investigator Email
- alenka.fialova@seznam.cz
- Contact Person Name
- Alena Fialová
- Contact Person Email
- alenka.fialova@seznam.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 399
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Semmelweis University
- Department Name
- Dermatology
- 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 Szeged
- Department Name
- Dermatology
- Principal Investigator Name
- Rolland Gyulai
- Principal Investigator Email
- trial.office@szte.hu
- Contact Person Name
- Rolland Gyulai
- Contact Person Email
- trial.office@szte.hu
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 25-09-2024
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 505
- Number Of Sites
- 8
- Number Of Participants
- 13
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Dermatology
- Principal Investigator Name
- Eduardo Lopez Bran
- Principal Investigator Email
- Eeccderma.hcsc@salud.madrid.org
- Contact Person Name
- Eduardo Lopez Bran
- Contact Person Email
- Eeccderma.hcsc@salud.madrid.org
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Dermatology
- Principal Investigator Name
- Alicia González Quesada
- Principal Investigator Email
- alicia.gonzalez@ulpgc.es
- Contact Person Name
- Alicia González Quesada
- Contact Person Email
- alicia.gonzalez@ulpgc.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Yolanda Gilaberte Calzada
- Principal Investigator Email
- ygilaberte@salud.aragon.es
- Contact Person Name
- Yolanda Gilaberte Calzada
- Contact Person Email
- ygilaberte@salud.aragon.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- Ángeles Flórez Menendez
- Principal Investigator Email
- angeles.florez.menendez@sergas.es
- Contact Person Name
- Ángeles Flórez Menendez
- Contact Person Email
- angeles.florez.menendez@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Esther Serra Baldrich
- Principal Investigator Email
- eserra@santpau.cat
- Contact Person Name
- Esther Serra Baldrich
- Contact Person Email
- eserra@santpau.cat
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Dermatology
- 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
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Dermatology
- Principal Investigator Name
- Jose Manuel Carrascosa Carrillo
- Principal Investigator Email
- jmcarrascosac.germanstrias@gencat.cat
- Contact Person Name
- Jose Manuel Carrascosa Carrillo
- Contact Person Email
- jmcarrascosac.germanstrias@gencat.cat
- Site Name
- Icr Medical S.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Álvaro González Cantero
- Contact Person Name
- Álvaro González Cantero
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.
Third parties
- {"country":"United States","full_name":"Rancho BioSciences LLC","duties_or_roles":"Data analysis","organisation_type":"Industry"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mount Sinai","duties_or_roles":"","organisation_type":"Health care"}
- {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Innovaderm Research Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Investigator Meeting Planner; Patient Travel and Meal Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment rental","organisation_type":"Industry"}
- {"country":"United States","full_name":"Scisafe Inc.","duties_or_roles":"Long-term storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pestka Biomedical Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training Platform, Investigator Meeting Planner","organisation_type":"Industry"}
- {"country":"United States","full_name":"Alamar Biosciences Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Medical photography and image analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc. (Corporate Boulevard address)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc. (Fortune Circle West address)","duties_or_roles":"Sample storage/aliquoting","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"PD Value","duties_or_roles":"Data analysis","organisation_type":"Industry"}
- {"country":"United States","full_name":"Meso Scale Diagnostics LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"PD Value (duplicate entry)","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Various laboratory and service providers (IQVIA, Rules Based Medicine, Pestka, etc.)","duties_or_roles":"","organisation_type":"Mixed (Laboratory/Industry/Pharmaceutical)"}
Investigational products
- Investigational Product Name
- APG777
- Active Substance
- APG777
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Investigational medicinal product for clinical trial (MIA DE_BW_01_MIA_2023_0054)
- Investigational Product Name
- Placebo
- Modality
- Other
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Comparator (matching placebo for trial)
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