Study on the Safety and Effectiveness of APG777 for Patients with Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate a new treatment called APG777, which is a solution for injection. The purpose of the study is to assess the safety and effectiveness of APG777 in patients with moderate-to-severe Atopic Dermatitis. Participants in the study will receive either the APG777 treatment or a placebo, which is a substance with no active medication.

The study is divided into two parts. In Part A, the effectiveness of APG777 will be compared to the placebo after 16 weeks of treatment. In Part B, three different doses of APG777 will be tested against the placebo, also over a 16-week period. Throughout the study, participants will receive regular injections and attend scheduled visits to monitor their progress and any side effects. The study aims to provide valuable information on how well APG777 works and its safety profile over time.

Participants will be monitored for changes in their skin condition, including the severity and area affected by eczema, which is a common symptom of Atopic Dermatitis. The study will also track any adverse events or side effects that may occur during the treatment period. The overall duration of the study is expected to last up to 106 weeks, allowing researchers to gather comprehensive data on the long-term effects of APG777.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient will be required to provide consent to participate in the study.

2 baseline assessment

The patient will undergo a baseline assessment to evaluate the severity of atopic dermatitis. This includes completing itch questionnaires and applying a stable dose of non-medicated moisturizer for at least 14 days prior to the baseline visit.

3 treatment phase part A

The patient will receive either the medication APG777 or a placebo through a subcutaneous injection. This phase lasts for 16 weeks. The effectiveness of APG777 will be compared to the placebo.

4 treatment phase part B

In this phase, the patient will receive one of three different doses of APG777 or a placebo. This phase also lasts for 16 weeks. The goal is to evaluate the effectiveness of different doses of APG777.

5 follow-up assessments

Throughout the study, the patient will have regular follow-up assessments to monitor changes in the eczema area and severity index (EASI) and other health indicators. These assessments will occur at baseline, week 16, and week 52.

6 monitoring for side effects

The patient will be monitored for any side effects that may occur during the study. This monitoring will continue for up to 106 weeks.

7 completion of the study

Upon completion of the study, the patient will have a final assessment to evaluate the overall effectiveness and safety of APG777.

Who Can Join the Study?

  • Have a diagnosis of Atopic Dermatitis (AD) that has been present for at least 1 year before the Screening visit. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
  • Have moderate-to-severe Atopic Dermatitis at both the Screening and Baseline visits. This means the condition is more than mild and affects daily life.
  • Have a history of not responding well to treatment with creams or ointments applied to the skin, or a doctor has decided that these treatments are not suitable.
  • Have been using a stable dose of a non-medicated over-the-counter skin moisturizer of their choice for at least 14 days before the Baseline visit and agree to keep using the same moisturizer throughout the study, except on the day of the study visits.
  • Have completed itch questionnaires in the electronic diary for at least 4 out of 7 days before the Baseline visit. This means keeping track of itching symptoms regularly.
  • Both male and female participants are eligible.
  • Participants should not be part of a vulnerable population, meaning they should be able to give informed consent and participate fully in the study.

Who Cannot Join the Study?

  • Patients who do not have moderate-to-severe Atopic Dermatitis cannot participate. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and effectiveness of the treatment being tested.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ICMR (International Center for Medical Research) Madrid Spain
Technische Universitaet Dresden Dresden Germany
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Sanatorium profesora Arenbergera Prague Czechia
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Rosenpark Research GmbH Darmstadt Germany
Du Docteur Ruer S.E.L.A.R.L. Martigues France
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Dermatologikum Hamburg GmbH Hamburg Germany
University Of Debrecen Debrecen Hungary
Clintrial s.r.o. Prague Czechia
Prywatna Praktyka Lekarska Ewa Ring Warsaw Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Pratia S.A. Skorzewo Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
University Of Szeged Szeged Hungary
Kemlc aoesnvrul Fuzaozy sygwec Prague Czechia
Tcmsxdls Nhcc Sll z oimn Warsaw Poland
Udqdjfemru Meamlhf Cjtvbl Hkyspsshnyzcigvnm Hamburg Germany
Udexjybrwndgirdtfhsiy Anvdffbf Augsburg Germany
Cwvqztj Bnjug Kbwjtxzqccr Pdnubeza Scd z oove Gdansk Poland
Tvhnieqqzaj ujz Sbegkzdvwiu Bnocvxja Gwqi Bad Bentheim Germany
Djgujungb Smq z olws Wroclaw Poland
Llnchzz Sihdnyusbkxsvvu Ghsnopd Dlypvmjorihqqqe Lublin Poland
Fqvzmxes nguchusfj Mgkzj a Hpjuvrd Prague Czechia
Ufztlwdzlqevwfpzmiwlk Mrrkyjrl Aff Munster Germany
Gmuaqo Uvovyfnvgs Fpgagwssv Frankfurt Germany
Kvuktbnk dwz Uysxjdxubqxk Mdnlivvc Ahn Munich Germany
Dohkqaapag Skk z oobu Wroclaw Poland
Hgbnhoof Dh Lw Suuub Cidg I Sllp Pra Barcelona Spain
Hilmubpx Uajwxtlurqmmw Hwgodupl Tdary y Pbezbr Iswbnhuj Cczagd dxcucrlefhrgegylj (ggfg Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
01.09.2024
France France
Not recruiting
01.09.2024
Germany Germany
Not recruiting
01.09.2024
Hungary Hungary
Not recruiting
01.09.2024
Poland Poland
Not recruiting
01.09.2024
Spain Spain
Not recruiting
01.09.2024

Trial locations

Investigated drugs:

APG777 is a medication being studied for its potential to treat moderate-to-severe atopic dermatitis, a skin condition that causes red, inflamed, and itchy skin. The trial aims to assess how effective and safe APG777 is for patients over a 16-week treatment period.

Investigated diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease progresses through cycles of flare-ups and remissions, where symptoms can worsen and then improve. Commonly affected areas include the face, neck, and the insides of elbows and knees. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The condition can significantly impact quality of life due to persistent itching and discomfort.

Trial ID:
2024-511260-84-00
Protocol code:
APG777-201
NCT ID:
NCT06395948
Trial Phase:
Therapeutic exploratory (Phase II)

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