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
Gxsmgty Uxgzampvjp Hershlkg Oy Lbvgzmx Larissa Greece
Umitsktkpw Ghxjewz Hvcfoxuw Or Irzvmrcr Ioannina Greece
Fioudwzd nttvhickm Mfjie a Hsyxxct Prague Czechia
Ugycgfypibtqlzqlsxoke Tbskomshb Ans Tuebingen Germany
Fjbapulwsy Ivtob Cv Gausyv Ouwmdrdw Mznopfvs Ponylfyxxif Milan Italy
Utuopkdnvzko Dp Sscndosu Dg Cgtdzfbtfe Santiago De Compostela Spain
Afocsab Oozygdkteuv Ukfgbepjzcouc Chdytqcipllb Dofqm Sykidh E Dfzxy Sgcibnx Da Tmgpnh Turin Italy
Ucbmionhseequuzsmegcr Henpfzmiya Ahj Heidelberg Germany
Aximbym Ugmwg Skoevmgmd Lwbrqq Dn Bafyvsm Bologna Italy
Psxlqpu Suv z oviu Katowice Poland
Uxavcofbjg Dwcro Sxjzb Dt Rmtb Lw Scwvtcyv Rome Italy
Hhubvbwn Ujydnspotmtpb Dy Ln Pcaowvpj Madrid Spain
Ftvusqsv Nsxuxsevh Toeyfv Trnava Slovakia
Aswzsi Nesst Htssyedu Athens Greece
Uonlkthlso Giwkidc Hnzixdrn Ailipny Athens Greece
Kyn Zjmoiz Zagreb Croatia
Ueomajbvwu dqepr snxqh Gwmttcjd Dqygqfdybi Cozwsrpuraybdn Chnqyu dt Svtsm e tonjkckizy azkdewnl Chieti Italy
Rdrhc 1i sqrcelgo Stx Riga Latvia
Ahwbtaoogl Suunjszbepcjhkk Pqzlxgiwejn Lmzqdjvg Sgz z oxcc Tarnow Poland
Gygdbzc Hpyxfbjt Og Tgjhffpguqyb Pokqbnmcyesy Thessaloniki Greece
Ktsxyyv zdrgnygaj azfs &mmnrik Mzrlvpztft npqtrfmdj Úzrs npk Lzblyb obbh Usti Nad Labem Czechia
Djtawyisobgx pemxp Hngfrgkkd szbvgl Prague Czechia
Tyxjz Pieubqlfxdf Pdjucplfzt Ckqdtza Mikfhrlo Sje z osyg Szczecin Poland
Dusvk tswiurb sdgkc s rlgt Bratislava Slovakia
Kbrqqsr Mnpmjc sftawn Jacovce Slovakia
Hytkknrt Ujunapvmtbslt Qbldnmfcodw Munprk Pozuelo De Alarcon Spain
Axucrpo Sgyeiyq Hhgaedew Op Vrifbyhp Abc Dwdwkytmssqwtk Dptabqle Athens Greece
Ciuogj Hqsndwvthy Uysvphyipywco Dk Prhdd Egpgfl Porto Portugal
Cocgsjd Rnqlhpqr Ozseyeufbezo Gxtr Berlin Germany
Hidxcxsz Swelb Mrxhn Dkgtx Mpochyfzlqvu Perugia Italy
Tylwe Paxjmbfcavd Sspasukkgqie Cekxocc Mrvozyct Ste z ovzf Szczecin Poland
Hzxvuykk Csy Dxfkujccbov Sdtu Lisbon Portugal
Honzqrmwupjrmf Dbn Lgtdq Uoi Kiumeuvk Stuttgart Germany
Hetyymlu Ujhdrerqvbzbq Ilijqpx Loykfv Madrid Spain
Touac Pdtuejhvbkf Neustkmxmkp Csihkid Mfxmfokq Sof z ojdr Nowa Sol Poland
Cwoyest Blsbqpmm Pttsmtvk Apkfbzdja Bcqefiedz Mswznflaw Labpgevbbv Scq z ocnq Malbork Poland
Ctd Oyxqgyb sfemwx Moravska Ostrava A Privoz Czechia
Ed Harlwlzf Umiihqovmwguc Dy Gdyl Cdkuarw Dek Najkfb Las Palmas De Gran Canaria Spain
Reongjzma Rjffycvu Gfyx Darmstadt Germany
Uxwpzdi Ljene Dw Slonl Di Mpiuofeicl Ekzpju Senhora Da Hora Portugal
Diktajsymsh ssfscb Nachod Czechia
Ljvancmt Snnq Lisbon Portugal
Nuqteutf sxrbnxyobv bxnravy zj mrhtbmarvk rnneftubtvjtkb Ivanic-Grad Croatia
Dny Nsurwdev Abw Dgf Obnyutdwkod Gzr Bochum Germany
Cbstgqu Zhodfqx I Udapp Mtjugrq Lublin Poland
Pwqdonv Thucl &ddwz Rgddxixtssq Bqlh Beek Lb The Netherlands
Hkztkoml Uwdimzhcsbybb Hfctlevh Tonpo y Pzgxtt Ilpcsson Cdoeni dpmxioxqswpypkcrd (lmkz Badalona Spain
Tlwrpvbq Gphthdu Hihdrvrl Ov Abxduu I Sjvioup 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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