NCT06395948Active, not recruitingPhase 2
A Study Evaluating APG777 in Atopic Dermatitis
A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 470 (actual)
- First submitted
- 29 Apr 2024
- Start date
- 29 Apr 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- Apogee Therapeutics, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06395948
- EU CT number
- 2024-511260-84-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 470
- From 29 Apr 2024 to the primary completion date, Nov 2026
- 90 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a prior study with APG777.
- Prior treatment with protocol-specified monoclonal antibodies (mAbs)
- Has used any AD-related topical medications within 7 days prior to Baseline visit.
- 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
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Who the study is looking for
- Have a diagnosis of AD that has been present for \>=1 year prior to the Screening visit
- Moderate-to-severe AD at Screening and Baseline visits
- History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
- 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.
- Have completed itch questionnaires in the electronic diary for \>=4 of 7 days prior to Baseline visit
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (90)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Ajax | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Fredericton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Peterborough | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Kozni ambulance Fialova, s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Active, not recruiting |
| Sanatorium profesora Arenbergera Coordinator of this site? Confirm its status | Praha 1 | Czechia | Active, not recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Active, not recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Coordinator of this site? Confirm its status | Blankenfelde-Mahlow | Germany | Active, not recruiting |
| Rosenpark Research Gmbh Coordinator of this site? Confirm its status | Darmstadt | Germany | Active, not recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Dermatologikum Hamburg Gmbh Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Active, not recruiting |
| Icr Medical S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Du Docteur Ruer S.E.L.A.R.L. Coordinator of this site? Confirm its status | Martigues | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Dudley | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Luxderm Specjalistyczny Gabinet Dermatologiczny Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o Coordinator of this site? Confirm its status | Sosnowiec | Poland | Active, not recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| Therapia Nova Sp z o.o Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Prywatna Praktyka Lekarska Ewa Ring Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Dermaceum Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Boardman | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Bowling Green | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Douglasville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mason | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mill Creek | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| - Coordinator of this site? Confirm its status | West Lafayette | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
Related publications
- A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers.Clin Transl Sci · 2025 · PMID 41422501
This page is information, not medical advice. Discuss any trial with your doctor.