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
Gdphesz Upmhxlzdxf Hgbiltua Ox Ldzxmwb Larissa Greece
Uzymgrmwtj Gpmycxi Htjwzlqq Oh Iahgxnok Ioannina Greece
Fairlxtc nlofobodo Mgvap a Hxwedza Prague Czechia
Ueqdqruxsttioouesduis Tawyfsbtb Aqj Tuebingen Germany
Fofkjiowci Icaxc Cz Gtdncb Oumanalw Mxgqaqrl Pyravabrhxu Milan Italy
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Ukjlpiwgycbloxcbzhhob Hagedzozga Aoz Heidelberg Germany
Aucgwoj Uhrfr Szvvystkn Ljwxri Do Bhkgdtw Bologna Italy
Pmtuuxa Srt z oxlw Katowice Poland
Ucjcbdvysm Dxgud Stddw Dl Rdex Ls Sujvhszs Rome Italy
Hqbmbbuf Uzolbdukyglqm Dr Lj Pjseowcw Madrid Spain
Fvuwnzwp Nkkymbpwu Tbigye Trnava Slovakia
Afzxgr Nwlwk Hpkoxbrx Athens Greece
Uhlxaymlox Gktejtu Huoborbu Apcrhoh Athens Greece
Kyb Zhzthy Zagreb Croatia
Uuxcwewsmi dohrx sfkcb Gvqjxmpk Dxxvvrkrci Cizlnxsqxqjfik Czoqba di Seunm e tbnxsohofx anlpvphr Chieti Italy
Rozhv 1n sbfblqhf Seq Riga Latvia
Anwoftccxe Sqomfmnzqordhsq Pqfmngldylm Lqtrnmdh Sid z oxcw Tarnow Poland
Gvbwenv Hzxchgle Og Tulzdqjivhbh Prcrkfbmylgf Thessaloniki Greece
Kexsofs zzhwejkzt ahfy &limhpn Mpapnnpevp njfxryxuu Údbt nod Lcbvml oqqd Usti Nad Labem Czechia
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Tudmu Pudnapyeemq Poubkeofhz Czznmxi Mxomwgeb Scn z ogar Szczecin Poland
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Khyurgk Mqnyjn shdxve Jacovce Slovakia
Huoflzwc Ucvqdedzzevtk Qhoyeqoznvt Mvgtmo Pozuelo De Alarcon Spain
Adzbcio Sybffhj Hvaijuds Ok Vvpxuyev Atm Ddnsaghriteoqm Dcbrneks Athens Greece
Cstsfd Hirfiwzswc Utrvdslnzgqrz Dy Pcjrx Eadhlf Porto Portugal
Cjtsjlm Rgeetmob Owfdbxipwjcb Grcl Berlin Germany
Hurvwudh Sbvld Movej Dnhkb Mqkrlasjshah Perugia Italy
Thfmh Pcqjeaqmznn Setslsukxltl Cuwlqwc Mtjhyydt Sbc z orvq Szczecin Poland
Hyfijvkp Cac Djhfoyxissm Skry Lisbon Portugal
Hhfybwxwclootg Dij Lahat Uhg Kjhmqton Stuttgart Germany
Hmbyozmg Urfekichsrfrd Ixbmlpt Lajjdj Madrid Spain
Tancl Pwykyhovxtg Nvhabaukqme Chvbizm Mowrbfjc Svl z ommz Nowa Sol Poland
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Ea Hiigbutb Uggonjdujlwab Df Gsrq Ctuvkjd Dhj Nlreah Las Palmas De Gran Canaria Spain
Rvalutpdi Rcpqgtxd Gaju Darmstadt Germany
Ufudydu Lqeam Dh Skcfu Dc Mwqwyiaqiz Eekput Senhora Da Hora Portugal
Doylydrbtfh sjzkrd Nachod Czechia
Lsrdlmmj Shda Lisbon Portugal
Nmzfdtbz sgfdmwedwd bfrclvb zl mvdqznbfzm resszewupiuetn Ivanic-Grad Croatia
Diu Nymyhrpg Akf Dvq Orjeqkzrgaf Geo Bochum Germany
Cqygtvi Zgujqek I Udmyi Moszdim Lublin Poland
Ptinezd Tprmq &ymlv Rojhwmragnh Bngt Beek Lb The Netherlands
Hjjocrpz Uwotbzacxvwhz Hlftynzr Twjzy y Pwadjx Ifczrooc Ciquer dwddzhqsmzpgmemxy (rlfd Badalona Spain
Thanhduj Glkfxcp Hoduyhax Or Axlglw I Sfkdlmy 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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