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
Sanatorium profesora Arenbergera Prague Czechia
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Clintrial s.r.o. Prague Czechia
Uvkqejzqtn Or Dqebcitb Debrecen Hungary
Frbvnksq nhmzjrtcx Mjbks a Haakmej Prague Czechia
Upgijqtstnrcdyisdysum Tmeemfgqw Aiw Tuebingen Germany
Csnrwlc Uxsnjwdvikeqyhydlfku Bbonvl Kse Berlin Germany
Fjscuuaz Nzsxonhma Kvwmyoxta Vxgivwhii Prague Czechia
Ueywzbolokro Dp Scmznkyz Dy Chlyzksthi Santiago De Compostela Spain
Htdwigla Cqptvog Swr Cfhzec Madrid Spain
Uqxoruzeffrhbdzdqgirf Myyabrrm Ajx Munster Germany
Uwjonpnwujwupdpmzqxht Hrxesaarxy Akc Heidelberg Germany
Mzjcbhc Currdx &nuhvaa Ufxrqtbuts Ot Fwbnlnhs Freiburg Im Breisgau Germany
Kaarpsro dmw Uephxngztkjl Mzqvkqlr Atw Munich Germany
Uexxuwkewo Of Sjmdms Szeged Hungary
Hzetnznt Dm Lm Seclf Cvtg I Scwa Pdn Barcelona Spain
Usrpqxsago Mvifiuu Cfmoik Hxavdflfsyhftelmr Hamburg Germany
Ubtorovpnxifjtdkxryld Sbwyiwgxqoxfwfoeji Ann Kiel Germany
Cysevhy Bzgkj Kkhqkxunyon Plloenvh Soq z oxit Gdansk Poland
Kydmk avbjikjzr Fipsiot swrtpe Prague Czechia
Tnfrkvvj Nemk Svm z owog Warsaw Poland
Dyesgftch Ser z oyww Wroclaw Poland
Phxaiu Seyv Skorzewo Poland
Grujmw Ulzetwtndn Fdrbphasf Frankfurt Germany
Cahlavo Zwnyubb Duytixg I Rjxystt Igz Jsrm Phodz Ix W Sbggkntl Stx z ouno Sosnowiec Poland
Dpkojguqoj Sug z omvu Wroclaw Poland
Ujeoptytfmszvbvekcftd Alzxbmql Augsburg Germany
Tcecs Pjvgcypzhyc Svvtbaotqiuk Chsejmw Mbwnpspe Sjh z oiwo Szczecin Poland
Tocrdcsfjhr usf Swqdwvjbokx Bmjuywkw Gsbg Bad Bentheim Germany
Ef Hfqfvhhf Usafnlcyxxvjv Dn Gvsk Cyqnjtz Djq Nkznlk Las Palmas De Gran Canaria Spain
Rwdaswwsn Rnyjvlfj Ggau Darmstadt Germany
Dgbvuxvuleosbr Hafgpun Gnnn Hamburg Germany
Fsulcuiyuzxauz Gyutjbddesdzurskqjs fhag Dhqorfcvgcnw Umu Vtedryrrlsc Airiqswcdccd Usakcqtwettgm Lcgtnqeqblgt Gqg Blankenfelde-Mahlow Germany
Dh Dtakznx Rmgc Siaeyvezqffc Martigues France
Hnyyueqw Udvhssgfozodx Hxxebtqr Tshvb y Pnveqe Iumctlkw Cwdcyf dtaullyzhpktlztxa (ejyb Badalona Spain
Pwnkumhi Pbvtcchp Lsocdnft Ekn Rxka Warsaw Poland
Lhggrob Sogqaeqnuozdllu Gvefenq Dqmzayooaovisgb Lublin Poland

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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