Study on Rocatinlimab for Adults with Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This study is examining the effectiveness and safety of rocatinlimab (AMG 451) in treating adults with moderate-to-severe atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin, commonly known as eczema. The purpose of this research is to evaluate how well rocatinlimab works compared to a placebo over a 24-week period.

The study will assess improvement in atopic dermatitis using several measurements, including the Validated Investigator’s Global Assessment for Atopic Dermatitis (a scoring system used by doctors to rate the severity of eczema) and the Eczema Area and Severity Index (a tool that measures the extent and severity of eczema). The research will also track changes in pruritus (itching) and skin pain using numerical rating scales where patients rate their symptoms.

During the 24-week study period, participants will receive either rocatinlimab or placebo treatment. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication versus the placebo until the study is complete. This approach helps ensure that the results aren’t influenced by expectations about the treatment.

Who Can Join the Study?

  • You must be at least 18 years old or the legal adult age in your country, whichever is older
  • You must have been diagnosed with atopic dermatitis (a chronic, itchy skin condition also known as eczema) that has been present for at least 12 months before joining the study
  • You must have a history of inadequate response to topical treatments (creams or ointments applied to the skin) or have medical reasons why topical treatments are not advisable for you
  • You must have moderate-to-severe atopic dermatitis as defined by:
    • An EASI score (Eczema Area and Severity Index, which measures the extent and severity of eczema) of 16 or higher
    • A vIGA-AD score (Validated Investigator’s Global Assessment for Atopic Dermatitis, which rates overall eczema severity) of 3 or higher
    • At least 10% of your body surface area affected by atopic dermatitis
    • A pruritus NRS (Numerical Rating Scale for itching) score of 4 or higher, indicating moderate to severe itching in the past 7 days

Who Cannot Join the Study?

  • Having a diagnosis other than atopic dermatitis
  • Having used medications that affect the immune system (like systemic immunosuppressants) within a certain period before the study
  • Having used topical treatments for atopic dermatitis within a specified time before the study
  • Having received light therapy (like phototherapy) recently
  • Having an active skin infection that requires treatment
  • Having other skin conditions that might interfere with evaluating atopic dermatitis
  • Being pregnant or breastfeeding
  • Having significant liver or kidney problems
  • Having a history of cancer (except for certain skin cancers that have been completely removed)
  • Having a history of serious infections
  • Having active tuberculosis or other serious infections
  • Having participated in another clinical trial recently
  • Having previously used rocatinlimab (the study medication)
  • Having any condition that, in the opinion of the study doctor, would make it unsafe to participate

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
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Smite Aija practice in Dermatology Talsi Latvia
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Clinical Research Center s.r.o. Pardubice Czechia
Royalderm Agnieszka Nawrocka Warsaw Poland
Sanare spol. s r.o. Svidnik Slovakia
Veselibas Centrs 4 SIA Riga Latvia
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Akk Medical Sp. z o.o. Gdansk Poland

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Ospedale San Raffaele S.r.l. Milan Italy
Pratia Prague s.r.o. Prague Czechia
Clintrial s.r.o. Prague Czechia
Dermatologiczna Praktyka Lekarska Michal Torz, DERMACEUM Centrum Badan Klinicznych Wroclaw Poland
Fakultni Nemocnice Bulovka Prague Czechia
Vital Medical Center Veszprem Hungary
Gzevgft Uxhpsadqez Hqjorjqu Op Lyijfhx Larissa Greece
Uicqshpram Gtuvmvh Hmjhspqc Of Iuverfvq Ioannina Greece
Fefqodxh nuxwzzesj Mjydk a Htgkbcf Prague Czechia
Urhrdvmkeryzbawxekmor Tvwzbrtsx Ahq Tuebingen Germany
Fmacnxbpoe Izlyq Cp Ggfrio Olgsovye Mlcgitke Pejgdweysqj Milan Italy
Ujuhsognmcaq Dp Sjokcnpq Dk Cwjjpbfifn Santiago De Compostela Spain
Alkjosd Ogzhkaamddn Udrlisyyrkvbl Cfucwwmpgoga Dsudc Svbtok E Dyrpb Szfihtv Dz Thyftx Turin Italy
Uxszxwfkighftilylvokr Hazpyjdyew Alp Heidelberg Germany
Arqcybe Ustsb Svsmaurvp Lihtgw Dh Booyioz Bologna Italy
Pycqxaf Syh z oiia Katowice Poland
Uouvpptndq Dbeqm Sdqco Dv Rhmx Lg Shqpqcww Rome Italy
Htxhypsh Uapjucphyoxuq Dg Lq Ptdkgvrp Madrid Spain
Fjrodhkc Nhvuxsegw Tfyetl Trnava Slovakia
Audhms Nnced Hzzohxdx Athens Greece
Uifnurjyfz Gaaibba Hbpamtor Abgicqr Athens Greece
Khh Zysrbq Zagreb Croatia
Upnksqtsmn dxxpu shvok Ggwzokrf Dvybzbzten Csghywxpiilndm Czcflv dk Shqki e tqrojtpcfr aocuncnl Chieti Italy
Rbfxx 1x swlllnmp Sqj Riga Latvia
Amcasyuqab Sdwxrlhfvdvrshe Ppivuvuphzl Lwupwuoo Sxs z oilt Tarnow Poland
Gktrkhc Hspwbjal Oz Tkghmpptyujf Phwrpughsvuf Thessaloniki Greece
Kkkvzzc zzvjkuvnq aizp &oomfql Mvgaucriof npvmcfrwr Úknk nqx Lwcevs ozze Usti Nad Labem Czechia
Daflkxuwnxhv pperj Hdvzqdidw snfghi Prague Czechia
Tcfch Pfxqqexbpvo Prswsnhpci Cgmhyps Maaroixm Squ z opmm Szczecin Poland
Dmouy tdbblqv sxrhk s relz Bratislava Slovakia
Kwfeyld Mdpgdn sdykks Jacovce Slovakia
Hscuintr Uurhtuxorsmxl Qkvmjydzxfg Mwfsou Pozuelo De Alarcon Spain
Awbmimp Sifnwbi Hubobdqn Oh Vsifnpzl Aps Dmuxebhnykuapw Dapijwkn Athens Greece
Cqoqfy Hywkkqbzyn Uyqpldjnmqxfs Dz Pfrow Efdvqt Porto Portugal
Ctagnhw Rezdgibl Ojjhjkihtzpj Gpnt Berlin Germany
Hdjinihg Seadm Mabzo Dgzjq Mtqkbohywqqq Perugia Italy
Ttqfk Pjzmbfoixuz Saxsbeccjbso Cauvmds Mauihyqd Shz z oabk Szczecin Poland
Hgpmrakf Cza Ddwliyhtvln Sgjg Lisbon Portugal
Hmtmsudeopancr Dij Lhvto Upt Kgmeazxc Stuttgart Germany
Hdbfqpqs Urljgnwebyuhp Ichgfrt Lwzwls Madrid Spain
Tlqyo Pcgaqbxvhhn Nrvspekogdz Cgrrwcv Mmefsnda Sxy z oqts Nowa Sol Poland
Cpscdpj Bkzozmar Ptlbnmwt Amqhqpnwt Bcozbpssk Mkfvoqvmp Lpywwszujk Sbt z oaud Malbork Poland
Cjm Ostiytd sbvhic Moravska Ostrava A Privoz Czechia
Ep Hrapghrs Uulwgmlkqklok Da Gdyl Cvjdhqa Ddm Nljbre Las Palmas De Gran Canaria Spain
Rgpcgwofo Rykqccaw Gilx Darmstadt Germany
Urtiaoy Lcusb Df Sjxrm Dt Myutmkajsr Evyeqv Senhora Da Hora Portugal
Daqtievevkt sjcwkt Nachod Czechia
Ldluhdlp Sium Lisbon Portugal
Nfhvfksa swakmgvhax bdnbvgs ze mmyazmmrmy rsaebafgwmpqmt Ivanic-Grad Croatia
Dof Natbannp Ade Dgd Oyzmtxjatai Gkk Bochum Germany
Cxwmowe Zdbrhws I Uqltl Mfksbvh Lublin Poland
Pdyebsr Tbkul &ipgh Rkvdekeewyb Bkun Beek Lb The Netherlands
Hlzyowhj Uvbhbhgcoibja Hemwcocv Ttjsv y Ppmzry Ipghqanw Czkjfk dvaewkuzlakjxtcrg (eqiz Badalona Spain
Tanfwoce Gwoebve Hvevqome Oa Ahnxig I Scnijnz Athens Greece

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

Trial status

Country Status Recruitment Start
Croatia Croatia
Not recruiting
21.04.2023
Czechia Czechia
Not recruiting
21.04.2023
Germany Germany
Not recruiting
21.04.2023
Greece Greece
Not recruiting
21.04.2023
Hungary Hungary
Not recruiting
21.04.2023
Italy Italy
Not recruiting
21.04.2023
Latvia Latvia
Not recruiting
21.04.2023
Poland Poland
Not recruiting
21.04.2023
Portugal Portugal
Not recruiting
21.04.2023
Slovakia Slovakia
Not recruiting
21.04.2023
Spain Spain
Not recruiting
21.04.2023
The Netherlands The Netherlands
Not recruiting
21.04.2023

Trial locations

Investigated Drugs:

Rocatinlimab (also known as AMG 451) is a medication being studied for the treatment of moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition commonly known as eczema. This medication is designed to help reduce inflammation and improve symptoms like itching, redness, and rash that are associated with atopic dermatitis.

Placebo is a substance that contains no active medication. In this study, it’s used as a comparison to determine if rocatinlimab is effective. Some participants receive the actual medication while others receive the placebo, allowing researchers to measure the true effect of the medication.

Investigated Diseases:

Atopic Dermatitis – A chronic inflammatory skin condition characterized by intense itching and red, dry, scaly patches. It typically begins in childhood and may improve or worsen over time, appearing in flares triggered by various environmental factors. Atopic dermatitis often affects the skin folds, such as those inside the elbows, behind the knees, and on the face and neck. The condition can cause significant discomfort due to persistent itching, which may lead to skin damage from scratching. Many patients with atopic dermatitis also have other allergic conditions like asthma or hay fever.

Trial ID:
2022-501540-15-00
Protocol code:
20210142
NCT ID:
NCT05398445
Trial Phase:
Therapeutic confirmatory (Phase III)

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