Study on the Long-Term Safety and Effectiveness of Amlitelimab for Adults with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying the long-term effects of a treatment for atopic dermatitis, a condition commonly known as eczema, which causes the skin to become itchy, red, and inflamed. The treatment being tested is called amlitelimab, which is given as an injection under the skin. The study aims to understand how safe and tolerable this treatment is for adults who have moderate to severe forms of atopic dermatitis.

Participants in the study will receive the amlitelimab treatment over a period of time, and researchers will monitor them to see how their condition responds. The study will also include a comparison with a group receiving a placebo, which is a substance with no active medication. This helps researchers determine the true effects of the treatment. The study will track any side effects or changes in the participants’ skin condition, as well as their overall health and quality of life.

The goal of this research is to gather information on the safety and effectiveness of amlitelimab for treating atopic dermatitis. By participating, individuals contribute to a better understanding of how this treatment can help manage the symptoms of eczema and improve the lives of those affected by this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to confirm eligibility. This includes checking if you have had atopic dermatitis for at least one year and if you have tried other treatments without success.

You will undergo a physical examination, and your skin condition will be assessed using specific scales to measure the severity of your dermatitis.

2 treatment administration

You will receive the medication amlitelimab as a solution for injection. This will be administered under the skin, known as a subcutaneous injection.

The frequency and dosage of the medication will be determined by the study protocol, and you will be informed about the schedule for receiving these injections.

3 regular follow-up visits

You will attend regular follow-up visits to monitor your response to the treatment. These visits will include assessments of your skin condition and any side effects you may experience.

During these visits, you will be asked to report any changes in your symptoms and overall health.

4 safety and efficacy assessments

Throughout the study, the safety of the treatment will be closely monitored. This includes checking for any adverse events or side effects that may occur.

The effectiveness of the treatment will also be evaluated by measuring changes in your skin condition and quality of life.

5 end of study procedures

At the end of the study, you will have a final visit where your overall health and skin condition will be assessed.

You will be provided with information about the results of the study and any further steps you may need to take regarding your treatment.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the informed consent.
Participants must have had atopic dermatitis (AD) for 1 year or longer. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
Participant must have a documented history within 6 months before the screening visit of either not responding well to or being advised against using topical treatments. Topical treatments are medications applied directly to the skin.
Participant must have an Eczema Area Severity Index (EASI) score of 16 or higher at the baseline visit. The EASI is a tool used to measure the extent and severity of eczema.
Participant must have a Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) score of 3 or 4 at the baseline visit. This scale is used to assess the overall severity of atopic dermatitis.
Participant must have atopic dermatitis affecting 10% or more of their body surface area (BSA) at the baseline visit. Body surface area refers to the percentage of the body affected by the condition.
Participant must have a weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) score of 4 or higher at the baseline visit. This scale measures the intensity of itching.
Participant must be able and willing to attend study visits and follow study procedures.
Participants must use contraception as per local regulations. Female participants must not be pregnant or breastfeeding.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the study.
Patients who have had a severe allergic reaction to any medication in the past.
Patients who are currently participating in another clinical trial.
Patients who have a history of certain infections, such as tuberculosis.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who are pregnant or breastfeeding.
Patients who have received certain vaccines recently.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have a history of drug or alcohol abuse.
Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Rostock University Medical Center	Rostock	Germany
Evimed Sp. z o.o.	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
Amphia Hospital	Breda	The Netherlands
Klinische Forschung Osnabrueck	Osnabrück	Germany
Clintrial s.r.o.	Prague	Czechia
Fakultni Nemocnice Bulovka	Prague	Czechia
Hautarztpraxis Dr. Mihaescu	Augsburg	Germany
Hrohqfw Hzorp Mlhksu &uxhsyh 1 rgw Gzlhsyp Ehozhx	Creteil	France
Vgqtbt dew Roohd Uyayhflean Hcsjhdiy	Sevilla	Spain
Fhmhcoivmo Ifkji Cj Gawnrv Oeflumfe Mqffpbxx Prutnhcidnl	Milan	Italy
Aiopoijihi Paskurrp Hzgxhlhe Db Murgkwjbb	Marseille	France
Urkyswnjbjpt Mjdzpyj Cvqzewq Ultyixp	Utrecht	The Netherlands
Cxnvqh Hiutfjhyoxj Utshumxofujdt Dl Tbpzwswi	Toulouse	France
Eouiknt Utldkelnguos Mspuenh Cxntrld Rpnanvcqh (zbsonuo Mmx	Rotterdam	The Netherlands
Fvqtlcyz Nmdsdixad Kzktfurru Vxmrohzla	Prague	Czechia
Ufhodwulogqztnrggkucs Mgywuifp Akl	Munster	Germany
Aifcinz Oxctjfxzndq Uxbpafonswqzy Fklgeshj Is Da Nqwoba	Naples	Italy
Nkwfrhwwf Ajuj Nycu Jxhqo aekk	Novy Jicin	Czechia
Pehrhiv Sqg z opuu	Katowice	Poland
Uxignrfudx Dprxm Sbllm Ds Rjof Lc Skytvvko	Rome	Italy
Cidkkb Hnnkyawvneb Lyvc Sqn	Pierre Benite	France
Ugqeaqrfrh Dcgkl Sgsjb Dq Boaledv	Brescia	Italy
Ftxrnogbv Pqxh Lf Ixxrhcpoqwizq Bdmsqtwtb Dvp Haicvqxy Ugrhltyjekoej Lg Pqf	Madrid	Spain
Cihsnin Bpuqb Krhtfzdpxus Pqipxqsl Sbz z olpr	Gdansk	Poland
Ppzg Tjngz Hxkmyknj Ujyibysleseu	Sabadell	Spain
Koqyw aacunnxqe Flctivf srvkpi	Prague	Czechia
Liektzi Swuckdmsdehqalq Gjrifkz Dqqfwarpzhnausn	Lublin	Poland
Dfagsujewy Mnwtfcv Dnxtuimxvaw Cwspuh Dv Ng Mekm Eynte Gzdzlc	Chorzow	Poland
Ayjzaqehet Phizbqqk Hjezaxoa Dv Pdajr	Paris	France
Aszsfv Unacshfnyu Htpwgbtu	Aarhus	Denmark
Cdxgoef Rqtlqwtn Oniwtlckccly Gaos	Berlin	Germany
Aukkhvd Ukbjr Lqddww Swytz Ssxhiflho N 8 Bqbhms	Vicenza	Italy
Tfqobfqtnnb uzz Syjhdzxmjee Bywcfwdr Gycs	Bad Bentheim	Germany
Cpb Ofdldxw saujjs	Moravska Ostrava A Privoz	Czechia
Cgotqerp Ruchbjfv Glqvn Sek z omnj	Warsaw	Poland
Hdvolici Uayqnbiuzzsck Hfdkebuz Tovqh y Pnmngw Ibrhgugh Cecrrx dtbxzyjfvsplhyopx (zjtx	Badalona	Spain
Rialrvjfl Apaibbhsu Nxrylbom	Warsaw	Poland
Ptezpck Psvxoyul &fmlldf Dmp Mlcomomz Hoofpgfh	Witten	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	16.08.2023
Denmark	Not recruiting	16.08.2023
France	Not recruiting	16.08.2023
Germany	Not recruiting	16.08.2023
Italy	Not recruiting	16.08.2023
Poland	Not recruiting	16.08.2023
Spain	Not recruiting	16.08.2023
The Netherlands	Not recruiting	16.08.2023

Trial locations

Investigated Drugs:

Amlitelimab

Amlitelimab is a medication being studied for its potential to help people with moderate to severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication is given as an injection under the skin. The main goal of using amlitelimab in this study is to see how safe it is for long-term use and how well it can help manage the symptoms of atopic dermatitis. Participants in the trial receive this medication to see if it can improve their skin condition over time without causing significant side effects.

Investigated Diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin barrier is compromised, leading to increased sensitivity and susceptibility to infections. It commonly affects areas such as the face, neck, and the insides of elbows and knees. The condition is associated with other allergic disorders like asthma and hay fever. Over time, repeated scratching can lead to thickened skin and further irritation.

Trial ID:

2022-502188-39-00

Protocol code:

LTS17789 / ATLANTIS

NCT ID:

NCT05769777

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Long-Term Safety and Effectiveness of Amlitelimab for Adults with Moderate to Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?