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

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What is this study about?

This clinical trial aims to evaluate the effectiveness, safety, and tolerability of rocatinlimab (also known as AMG 451) in treating adults with moderate-to-severe atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and inflamed skin patches, commonly known as eczema. The study will compare the effects of rocatinlimab monotherapy (treatment with only this medication) against a placebo over a 24-week period.

The research will assess whether rocatinlimab can improve the condition of patients’ skin by reducing the severity and affected areas of eczema. The study will measure improvements in skin appearance, reduction in pruritus (itching), decrease in skin pain, and overall quality of life for participants. It will specifically examine whether participants achieve clear or almost clear skin on their face, hands, and other body areas after treatment.

Throughout the 24-week study period, participants will receive either rocatinlimab or placebo and will need to regularly report their symptoms and complete assessments. The research is designed for adults who have had atopic dermatitis for at least 12 months and have not responded adequately to previous treatments for their condition.

1 Study Enrollment and Initial Assessment

After joining the study, your moderate-to-severe atopic dermatitis (a chronic, itchy skin condition also known as eczema) will be assessed using several measurements including the Eczema Area and Severity Index (EASI) and the Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD).

Your itching severity will be measured using a numerical rating scale, and you will need to have a score of at least 4 on this scale to participate.

The study will confirm that you have had atopic dermatitis for at least 12 months and have not responded adequately to previous treatments.

2 Random Assignment to Treatment Group

You will be randomly assigned to receive either rocatinlimab (AMG 451) or a placebo (an injection that contains no active medication).

Neither you nor the study doctor will know which treatment you are receiving. This is called a ‘double-blind’ study.

3 Treatment Period (24 weeks)

You will receive injections of either rocatinlimab or placebo for 24 weeks (approximately 6 months).

The medication will be administered as a solution for injection, though the exact dosage and frequency of injections are not specified in the provided information.

4 Regular Assessments

Throughout the 24-week period, your skin condition will be regularly evaluated by healthcare professionals.

You will need to complete daily scoring of your itching severity.

You will also need to complete weekly scoring of your eczema skin pain.

Your quality of life will be assessed using the Dermatology Life Quality Index (DLQI), which measures how your skin condition affects your daily life.

5 Key Assessment at Week 16

At week 16, your skin will be evaluated to determine if it has become clear or almost clear based on the vIGA-AD scale.

Your itching severity will also be assessed at this point to determine if there has been improvement compared to the beginning of the study.

6 Final Assessment at Week 24

At the end of the 24-week study period, comprehensive assessments will be conducted to evaluate the effectiveness of the treatment.

These assessments include checking whether your eczema has improved by at least 75% based on the EASI score.

Your skin will be evaluated to determine if it has become clear or almost clear.

Specific attention will be given to checking whether there is clear skin on your face and hands.

Your itching severity, eczema skin pain, and quality of life will be assessed to determine improvements compared to the start of the study.

Who Can Join the Study?

Age 18 or older with atopic dermatitis (a chronic, itchy skin condition also known as eczema) that has been present for at least 12 months, diagnosed according to the American Academy of Dermatology Consensus Criteria from 2014
History of not responding well enough to certain previous medications used to treat atopic dermatitis
EASI score of 16 or higher (this is a measurement tool that evaluates the severity and extent of eczema on different body areas)
vIGA-AD score of 3 or higher (this is a tool doctors use to assess the overall severity of atopic dermatitis; a score of 3 means moderate to severe disease)
Worst pruritus numerical rating scale of 4 or higher (this means your itching severity, when at its worst, is at least moderate on a scale where patients rate their itching from 0 to 10)

Who Cannot Join the Study?

Current diagnosis of erythrodermic atopic dermatitis (a severe form of skin inflammation that affects most of the body)
Prior use of rocatinlimab (the study medication)
Prior use of lebrikizumab (another medication for atopic dermatitis) within 6 months of screening
Recent use of certain medications including:
- Systemic antibiotics within 2 weeks before first dose
- Topical treatments for atopic dermatitis within 2 weeks before first dose
- Systemic corticosteroids within 4 weeks before first dose
- Other systemic medications for atopic dermatitis within set time periods
History of poor response to 2 or more different systemic therapies for atopic dermatitis
Any active skin infection requiring treatment
Current or history of certain serious skin conditions other than atopic dermatitis
History of any medical condition that could interfere with the study or put you at risk
Pregnant or breastfeeding women
People with significant laboratory abnormalities
People with evidence of active or latent tuberculosis (an infectious disease primarily affecting the lungs)
History of cancer within the past 5 years (except certain skin cancers that have been successfully treated)
Having received a live vaccine (containing weakened but living microorganisms) within 12 weeks before study start

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Klinikum Bielefeld gGmbH	Bielefeld	Germany
Hautzentrum Friedrichshain	Berlin	Germany
Clinical Research Center s.r.o.	Pardubice	Czechia
Evimed Sp. z o.o.	Warsaw	Poland
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Hospital Universitario De Navarra	Pamplona	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Amicare Sp. z o.o. S.K.	Lodz	Poland
Karolinska University Hospital	Solna	Sweden
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Tartu University Hospital	Tartu	Estonia
Velocity Clinical Research Germany GmbH	Leipzig	Germany
Pratia Prague s.r.o.	Prague	Czechia
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
Praglandia s.r.o.	Prague	Czechia
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
CRS Clinical Research Services Management GmbH	Berlin	Germany
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Suomen Terveystalo Oy	Helsinki	Finland
Gentofte Hospital	Hellerup	Denmark
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Clinical Research Services Turku CRST Oy	Turku	Finland
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Appletreeclinics Network Sp. z o.o.	Lodz	Poland
CRST Helsinki Oy	Helsinki	Finland
Oulu University Hospital	Oulu	Finland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Dermatologikum Hamburg GmbH	Hamburg	Germany
Associatie dermatologie Maldegem	Maldegem	Belgium
Klinische Forschung Osnabrueck	Osnabrück	Germany
Odense University Hospital	Odense	Denmark
North Estonia Medical Centre Foundation	Tallin	Estonia
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Fakultni Nemocnice Plzen	Plzen	Czechia
Centermed Krakow Sp. z o.o.	Cracow	Poland
Klinika Osipowicz & Turkowski Sp. z o.o.	Warsaw	Poland
Czpqha Hpnnzsojpg Uchhukeitnglh Do Pjkyo Exykjc	Porto	Portugal
Fmomd ek Shibvgjs Snjjkvl Rdgmzq Swxwvvdtu	Herstal	Belgium
Ckelggjd Bubp Svelupism Syo z opdm Snvk	Lublin	Poland
Dqrolygukv Mebrdix Difzdfjsdex Chelue Dl Nx Mqbr Ehsaz Gofzth	Chorzow	Poland
Mxvxujbse Dnelggpmtfpi	Remscheid	Germany
Uacboelxokpero Cytyzly Kzanvdltc	Gdansk	Poland
Mqvrxkfcjrggiqhjfmsdokneyi Hzsnxwgyqlnfzsyf	Halle (Saale)	Germany
Foiszjssb Pcdt Lb Iybmmspgkjdqf Byamyxabd Dom Hnklssaa Uvrmoyprkmerf Ld Pmj	Madrid	Spain
Ttioutzleoe ujp Sqcnmqmlmtm Bxlvmiiu Gged	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.04.2023
Czechia	Not recruiting	30.04.2023
Denmark	Not recruiting	30.04.2023
Estonia	Not recruiting	30.04.2023
Finland	Not recruiting	30.04.2023
Germany	Not recruiting	30.04.2023
Poland	Not recruiting	30.04.2023
Portugal	Not recruiting	30.04.2023
Romania	Not recruiting	30.04.2023
Spain	Not recruiting	30.04.2023
Sweden	Not recruiting	30.04.2023

Trial locations

Investigated drugs:

Rocatinlimab

Rocatinlimab (AMG 451) is a medication being studied for the treatment of moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition also known as eczema. It works by targeting specific parts of the immune system that are involved in causing the inflammation and symptoms of atopic dermatitis. In this study, researchers are testing whether this medication can reduce the severity and affected area of eczema compared to a placebo.

Placebo is an inactive substance that looks like the medication being tested but contains no active ingredient. It’s used as a comparison to determine if the active medication (rocatinlimab) produces real benefits.

Atopic Dermatitis – A chronic inflammatory skin condition characterized by intense itching and red, inflamed skin lesions. It typically presents as dry, scaly patches that can become crusty, oozing, or bleeding when scratched. Atopic dermatitis commonly begins in childhood and often occurs in people who have a personal or family history of allergies or asthma. The condition tends to flare periodically and may be triggered by environmental factors, irritants, stress, or allergens. It frequently affects the face, hands, neck, inner elbows, and backs of the knees. The disease follows a relapsing-remitting course with periods of exacerbation alternating with periods of improvement.

Trial ID:

2022-501538-44-00

Protocol code:

20210143

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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