Long-term safety and effectiveness study of APG777 injection in patients with moderate-to-severe atopic dermatitis who previously received APG777 treatment

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What is this study about?

This study focuses on patients with atopic dermatitis, a chronic inflammatory skin condition that causes itchy, red, and inflamed skin. The research evaluates a medication called APG777, which is given as a subcutaneous injection (an injection under the skin). The purpose is to assess the long-term safety and effectiveness of APG777 in people with moderate-to-severe atopic dermatitis who have previously received this treatment.

The study will involve participants who have already completed an earlier trial of APG777. During this extended treatment period, participants will continue receiving APG777 injections for up to three years. Some participants may receive a placebo during the study. Throughout the study, participants will be allowed to use non-medicated moisturizers to help manage their skin condition.

The research will monitor how well the medication controls atopic dermatitis symptoms over time, including improvements in skin appearance, reduction in affected areas, and relief from itching. The study will also track any side effects that may occur during the extended treatment period. Regular assessments will measure the amount of APG777 in participants’ blood to understand how the medication works in the body over a longer period.

1 Initial qualification

You must have completed a previous APG777 treatment study and followed all study requirements correctly

Your doctor needs to confirm that continuing treatment with APG777 would be beneficial for your atopic dermatitis

You need to continue using the same non-prescription moisturizer that you used in your previous study

2 Treatment period

You will receive APG777 through subcutaneous injection (injection under the skin)

The treatment period will last approximately 2-3 years

Regular monitoring of your skin condition will occur using specific measurement tools:

– Assessment of the extent and severity of your atopic dermatitis

– Evaluation of skin clearance

– Tracking of daily itching intensity using a rating scale

3 Ongoing assessments

Your doctor will monitor any side effects throughout the study period

Blood samples will be taken to measure the levels of APG777 in your body

Your use of any additional treatments for atopic dermatitis will be recorded

The effectiveness of the treatment will be regularly evaluated through skin examinations

4 Study duration

The study is expected to run from October 2025 to December 2029

Your participation may last up to 3 years

Regular clinic visits will be required throughout the study period for monitoring and assessments

Who Can Join the Study?

  • Must have previously participated in and completed treatment with APG777 in an earlier study
  • Must have followed all study rules and instructions properly during the previous study, as determined by the study doctor
  • The study doctor must believe that continuing long-term treatment with APG777 would be beneficial for the patient
  • Must be willing to continue using the same non-prescription moisturizer that was used in the previous study throughout this extended study period
  • Must be either male or female
  • Must be an adult (age 18-64) or elderly (age 65+)
  • Must have moderate-to-severe atopic dermatitis (a chronic inflammatory skin condition causing itchy, dry, and irritated skin)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • History of severe allergic reactions to medications
  • Pregnancy or breastfeeding
  • Active skin infections
  • Current participation in other clinical trials
  • Use of other treatments for atopic dermatitis in the past 4 weeks
  • Serious medical conditions that could interfere with the study, such as liver disease, kidney disease, or cancer
  • History of immunosuppression (weakened immune system)
  • Significant skin conditions other than atopic dermatitis
  • Mental health conditions that could affect ability to follow study procedures
  • Substance abuse within the past year
  • History of poor compliance with medical treatments
  • Blood disorders or abnormal blood test results
  • Serious heart conditions or uncontrolled high blood pressure
  • Unable to attend regular study visits or follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name City Country Status
Clintrial s.r.o. Prague Czechia
Semmelweis University Budapest Hungary
Uaeavanwnh Om Dkzjwzmt Debrecen Hungary
Frdiffvs nynagucwo Mfsss a Hwtyjdw Prague Czechia
Utqvcuupaaixrxzfknglp Tcigopjza Anz Tuebingen Germany
Czzlfex Uqjuxwvbvuckxxroeoog Blmvwk Kmq Berlin Germany
Fqzswkhv Nhmyzrynq Kqiumwthj Vybdrqgaz Prague Czechia
Ujabdmoagvjm Dt Sxaonzsm Dy Ciethcmxup Santiago De Compostela Spain
Uvaopeayadustvsyygabu Mpblzciq Agz Munster Germany
Uvnzirkqkdodzhoaoccpm Hedtirlyaz Amr Heidelberg Germany
Mgnfajk Ctrfyk &gngnba Uajvaedgva Oh Fsijdzcp Freiburg Im Breisgau Germany
Kxklucrf doz Uwsmbpseqeaj Mbjzrorl Avw Munich Germany
Uysbuzcvbf Oj Sckksh Szeged Hungary
Uylsdpltwbvqodcispsat Sdbioznuvxajureabc Afb Kiel Germany
Cpbzzwr Bwmpf Kcfvghlotsa Pzzawltd Srv z ofeq Gdansk Poland
Kyhch assdmebnj Fgllpds szzalt Prague Czechia
Lfqypqr Sngjvkgwuatfekf Ggjzpry Dgulksebidwbays Lublin Poland
Thvnhnpe Ndac Svs z ouui Warsaw Poland
Plxbjcxw Pjmarvhj Lkmxwsdv Eqw Rdoh Warsaw Poland
Dsmrvcpaz Sjy z okzx Wroclaw Poland
Gmqlhp Uugkheewpu Fmmflxikt Frankfurt Germany
Uqzsotqkxbzlytohxwqlv Afrgjjms Augsburg Germany
Tmewg Psobrcmdqlz Stmvihofobsj Coyanbg Mgwhaaig Skp z oxbf Szczecin Poland
Tniwztgssll uvr Swhssjjqqse Bnogveho Gvwq Bad Bentheim Germany
En Hkdevlpq Uppzimhzdxpdb Dh Gaeo Cufpmnp Dyn Nvfrxz Las Palmas De Gran Canaria Spain
Rlqhlxhfb Rdgslfgx Gbzx Darmstadt Germany
Dbxqdjabyudouh Hdmwxnt Gybv Hamburg Germany
Fuzbagposffgoj Ghmzmhecpjzzbdcrsou fpga Dalgkjogsowr Uss Vxwsytfqkeu Amoqtcmrtarq Ufdpmbnifxsiq Ljnoxuxplquj Gbm Blankenfelde-Mahlow Germany
Dl Djvewcu Rmad Snxymvyqxzeb Martigues France
Htonlhjv Uizerdmzpowgw Hgnjunuz Tsywf y Pkegjt Inrbzilv Cfzwoo dantdjnhkwnjjnnnp (lwmm Badalona Spain
Dbmwqtcbxi Slp z ogtq Wroclaw Poland
Ctguegq Zpqfczz Dsedpzk I Ruksgsw Inu Jwub Pdpcz Il W Sujpcmoc Sdt z oqlt Sosnowiec Poland
Pqycji Ssjd Cracow Poland

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
01.10.2025
France France
Not yet recruiting
01.10.2025
Germany Germany
Recruiting
01.10.2025
Hungary Hungary
Recruiting
01.10.2025
Poland Poland
Recruiting
01.10.2025
Spain Spain
Recruiting
01.10.2025

Trial locations

Investigated Drugs:

APG777 is an investigational medication being studied for the treatment of atopic dermatitis (also known as eczema). It is being tested for long-term use in patients with moderate to severe atopic dermatitis who have previously received treatment with this medication. The purpose is to understand how safe and effective the medication is when used over an extended period of time.

Investigated Diseases:

Atopic Dermatitis – A chronic inflammatory skin condition that causes itchy, red, swollen, and cracked skin. The condition typically begins in early childhood but can occur at any age, often appearing in cycles of flare-ups and periods of improvement. It is characterized by intense itching, which can lead to scratching and further skin damage, creating a cycle known as the itch-scratch cycle. The condition commonly affects areas like the face, hands, feet, and the bends of elbows and knees. Atopic dermatitis is part of the “atopic triad,” which means it often occurs alongside asthma and hay fever. The condition can be triggered by various factors including stress, allergens, irritants, and changes in temperature or humidity.

Trial ID:
2024-519795-11-00
Protocol code:
APG777-202
Trial Phase:
Therapeutic exploratory (Phase II)

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