Study of rocatinlimab (AMG 451) in adolescents with moderate to severe atopic dermatitis to evaluate its effectiveness and safety over 52 weeks

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What is this study about?

This study focuses on testing a medication called rocatinlimab (also known as AMG 451) for treating atopic dermatitis, a chronic skin condition that causes itchy, inflamed, and red skin. The study aims to determine how well this medication works and how safe it is for adolescents with moderate to severe forms of the condition.

The research will compare rocatinlimab against placebo in adolescents who have not responded well enough to previous treatments with topical corticosteroids. The study will last for 52 weeks, with the main evaluation of the medication’s effectiveness happening at week 24. During the study, researchers will monitor changes in the severity of skin symptoms and the intensity of itching.

Throughout the study, participants will receive either rocatinlimab or placebo through injections. The study will measure several aspects of the skin condition, including how much of the body is affected by the disease, the severity of symptoms, and improvements in itching and skin pain. This is known as a double-blind study, which means neither the participants nor the doctors conducting the study will know who is receiving the actual medication versus the placebo during the treatment period.

1 Initial screening visit

During the first visit, your atopic dermatitis (AD) will be evaluated to confirm it meets the required severity level

The medical team will verify that you have had AD for at least 12 months

Your previous treatment history with topical corticosteroids will be reviewed

Assessment of your skin condition using the Eczema Area and Severity Index (EASI) will be performed

2 Day 1 – Start of treatment

Your skin condition will be reassessed to confirm eligibility

You will be randomly assigned to receive either rocatinlimab or a placebo

You will receive instructions on how to use the study medication

You will begin tracking your skin symptoms using a rating scale for itching and pain

3 Treatment period – Weeks 1-24

Regular visits to evaluate your skin condition will be scheduled

Your response to treatment will be monitored using the EASI score

You will continue recording daily ratings of itching and skin pain

The medical team will monitor any changes in your condition

4 Week 24 evaluation

A comprehensive assessment of your skin condition will be performed

The effectiveness of the treatment will be evaluated

Your EASI score will be measured

Your reported symptoms of itching and skin pain will be reviewed

5 Continued treatment – Weeks 24-52

You may be reassigned to a different treatment group

Treatment and monitoring will continue for an additional 28 weeks

Regular assessments of your skin condition will continue

The study will conclude at week 52

Who Can Join the Study?

  • Age between 12 and 17 years old at the start of the study
  • Must have Atopic Dermatitis (a chronic skin condition causing itchy, inflamed skin) that has been present for at least 12 months before joining the study
  • Must have had an inadequate response to topical corticosteroids (skin creams containing steroids) of medium to high strength, which means:
    • The treatment did not improve the condition despite using the cream daily for at least 28 days, or
    • The treatment could not be used due to side effects or safety concerns
  • Must have moderate to severe Atopic Dermatitis at both the screening visit and the first day of the study, measured by:
    • A score of at least 12 on the EASI (Eczema Area and Severity Index – a tool that measures the severity and extent of eczema) at screening
    • A score of at least 16 on the EASI on day 1 of the study
    • A certain level of itching severity based on a 7-day assessment
  • Both males and females can participate
  • Previous users of systemic treatments (medications taken by mouth or injection) for Atopic Dermatitis may participate after an appropriate waiting period

Who Cannot Join the Study?

  • Previous participation in a study involving rocatinlimab (an experimental medication)
  • Active or chronic infections, including:
    • Tuberculosis (a bacterial infection affecting the lungs)
    • Hepatitis B or C (viral infections affecting the liver)
    • HIV (Human Immunodeficiency Virus)
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Severe liver problems or abnormal liver function tests
  • Pregnant or breastfeeding women
  • Planning pregnancy during the study period
  • Use of other investigational drugs within 8 weeks before the study
  • Major surgery in the past 8 weeks
  • Serious heart conditions
  • Uncontrolled high blood pressure
  • History of severe allergic reactions to injectable medications
  • Current use of other medications for atopic dermatitis that could interfere with the study
  • Mental health conditions that could affect participation in the study
  • Drug or alcohol abuse in the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Amicare Sp. z o.o. S.K. Lodz Poland
Hopital Saint Joseph Marseille France
Hopital Prive D Antony Antony France
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
KBC Zagreb Zagreb Croatia
Centre Hospitalier Universitaire Rouen Rouen France
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
Clinical Medical Center Osijek Osijek Croatia
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Children’s Hospital Zagreb Zagreb Croatia
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Appletreeclinics Network Sp. z o.o. Lodz Poland
Rosenpark Research GmbH Darmstadt Germany
Athens Naval Hospital Athens Greece
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju Ivanic-Grad Croatia
Derma-B Kft. Debrecen Hungary
Associatie dermatologie Maldegem Maldegem Belgium
Klinika Ambroziak Sp. z o.o. Warsaw Poland
University Of Debrecen Debrecen Hungary
Hopital Purpan Toulouse France
Hôpital Pontchaillou-CHU Rennes Rennes France
Hospital Hotel Dieu Nantes France
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Derma Cluj Cluj Napoca Romania
Sibamed GmbH & Co. KG Leipzig Germany
Dermastyle S.R.L. Bucharest Romania
Specjlalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski SC Cracow Poland
Ddinjekzh Sss z ojmo Wroclaw Poland
Cfabfurds Uwafrxnneerxcf Ssoqdubhm Woluwe-Saint-Lambert Belgium
Anbvmju Ouwksfjyycr Uauvjmptdzshc Cpbdskranfug Dvnpu Sfxsyb E Dkpos Syubiyd Du Tekdwi Turin Italy
Pcvafof Sqp z oouv Katowice Poland
Uphydeetbzwrjz Cmugotd Khlsbrpwn Gdansk Poland
Hfscxyjq Dc Lw Spzps Cahm I Srmr Pmm Barcelona Spain
Flyeexmmn Psyd Lx Ioimfenyxrqzg Bogozrtxx Drk Heznumpe Uffcoypkbabjm Lk Pco Madrid Spain
Tsbsgtbneur ukg Sjxqhtyjtfe Bwsdsvbk Guse Bad Bentheim Germany
Glmfbi Uxzbhyamvg Fsmsohylk Frankfurt Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.06.2023
Croatia Croatia
Not recruiting
01.06.2023
France France
Not recruiting
01.06.2023
Germany Germany
Not recruiting
01.06.2023
Greece Greece
Not recruiting
01.06.2023
Hungary Hungary
Not recruiting
01.06.2023
Italy Italy
Not recruiting
01.06.2023
Poland Poland
Not recruiting
01.06.2023
Romania Romania
Not recruiting
01.06.2023
Spain Spain
Not recruiting
01.06.2023

Trial locations

Rocatinlimab (also known as AMG 451) is an investigational medication designed to treat moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition that causes itchy, red, and swollen skin. This medication is being studied as a potential treatment option for adolescents with this condition. It works by targeting specific components of the immune system that are involved in causing skin inflammation.

Atopic Dermatitis – A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in early childhood but can affect people of any age. It is characterized by periods of flare-ups where the skin becomes red, cracked, and intensely itchy, alternating with periods of relative calm. The condition often appears in patches on the hands, feet, ankles, neck, upper body, and limbs. People with atopic dermatitis may experience thickening of the skin in affected areas over time, and the condition is frequently associated with other allergic conditions.

Trial ID:
2022-501586-50-00
Protocol code:
20210145
Trial Phase:
Therapeutic confirmatory (Phase III)

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