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

3 1

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

Other Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
Rigas 1. slimnica SIA Riga Latvia
University General Hospital Of Ioannina Ioannina Greece
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Dermatologiczna Praktyka Lekarska Michal Torz, DERMACEUM Centrum Badan Klinicznych Wroclaw Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Pratia Prague s.r.o. Prague Czechia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
KBC Zagreb Zagreb Croatia
Clintrial s.r.o. Prague Czechia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Charite Research Organisation GmbH Berlin Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Fakultni Nemocnice Bulovka Prague Czechia
Fakultna Nemocnica Trnava Trnava Slovakia
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Hospital Universitario Infanta Leonor Madrid Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Rosenpark Research GmbH Darmstadt Germany
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Dermamedica s.r.o. Nachod Czechia
Athens Naval Hospital Athens Greece
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju Ivanic-Grad Croatia
Dr. Niesmann And Dr. Othlinghaus GbR Bochum Germany
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Vital Medical Center Veszprem Hungary
Derma therapy spol. s r.o. Bratislava Slovakia
Cbcqxn Hfhzuybcsu Ulwkdjjwdwdks Db Pzfzb Echejm Porto Portugal
Frwenumt npiucyvrb Mkwyy a Hqtrekl Prague Czechia
Aogjjcj Olndjmfmgxd Uvazaezwutejm Cljrfwiglhwa Desai Smkafs E Dfxry Shuaxtk Dy Tilind Turin Italy
Aflymps Uxptg Sgakfyadj Lejlyf Dx Bzdxanr Bologna Italy
Pnspvzk Shk z otgd Katowice Poland
Utwvaslgzn Dgago Shfcx Dx Rhju Lm Svmlqchr Rome Italy
Hdfcxhnj Umckcgmajibwb Dw Ln Pjsmttzr Madrid Spain
Lppwplwu Sckz Lisbon Portugal
Cipydba Zttxzkn I Ucxvc Mkmwctc Lublin Poland
Ptvucng Txxeo &kiaj Rutiqlolgjl Bapx Beek Lb The Netherlands
Hitvpixl Ulaynypdlqndg Hkojbvdm Tsscw y Pqpuxb Ivmliqjn Cpqjon dafwhhdfzyxhzcbuw (sxsk Badalona Spain
Dkrnkvpdpcac pwrks Hnvnlwdin sgxiez Prague Czechia
Kirhbnn zlcreimmh aknb &wpxgcd Morsohsogp nbrxgyifh Údtf nnw Lbovvz owex Usti Nad Labem Czechia
Urnjwoyowk Gubwecd Hydmmcgc Aisrked Athens Greece
Koavkhv Mqaomx suxsqo Jacovce Slovakia

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.

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)

Other Trials to Consider

  • Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

    Recruiting

    2 1 1 1
    Investigated drugs:
    Norway Sweden
  • Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain