Study on the Long-Term Safety and Efficacy of Nemolizumab for Adults and Adolescents 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 safety and effectiveness of a treatment called Nemolizumab for individuals with Atopic Dermatitis, which is a chronic skin condition that causes itchy and inflamed skin. The treatment involves using a solution for injection, which is administered under the skin. The study aims to understand how safe Nemolizumab is for people with moderate-to-severe atopic dermatitis over an extended period.

Participants in the study will receive Nemolizumab, which is also known by its code name CD14152 or CIM331. Some participants may receive a placebo. The study will monitor participants over a long duration to observe any side effects and to assess how well the treatment works in reducing the symptoms of atopic dermatitis. The study will also evaluate the impact of the treatment on the quality of life of the participants.

Throughout the study, participants will have regular visits to track their progress and any changes in their condition. The study will collect information on the severity of the skin condition, the level of itchiness, and any improvements in sleep and daily activities. The goal is to gather comprehensive data on the safety and benefits of Nemolizumab for managing atopic dermatitis.

1 joining the study

Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes having moderate-to-severe atopic dermatitis and a history of inadequate response to topical treatments.

The patient must agree to apply a moisturizer daily and use authorized topical therapy as needed.

2 initial treatment phase

The patient will begin treatment with nemolizumab, administered as a solution for injection under the skin (subcutaneous use).

The dosage and frequency of administration will be determined by the study protocol and the healthcare provider overseeing the trial.

3 ongoing treatment and monitoring

Throughout the study, the patient will receive regular injections of nemolizumab and attend scheduled visits to monitor the safety and effectiveness of the treatment.

The patient will be evaluated for any side effects or adverse events, and their atopic dermatitis symptoms will be assessed using various scales and questionnaires.

4 long-term follow-up

The study is designed to assess the long-term safety and efficacy of nemolizumab over a period that may extend up to 200 weeks.

During this time, the patient will continue to receive treatment and attend follow-up visits as outlined in the study schedule.

5 completion of the study

Upon completion of the study, the patient’s overall response to the treatment will be evaluated.

The patient will be informed about the outcomes and any further steps, if necessary, based on their individual health needs.

Who Can Join the Study?

  • Adolescents aged 12-17 who have not participated in a previous study with the medication Nemolizumab or those who may benefit from the study, as determined by the study doctor.
  • Participants must have atopic dermatitis affecting at least 10% of their body surface area.
  • Participants must have a SCORAD pruritus VAS score of at least 4.0, which measures itchiness on a scale from 0 to 10.
  • Participants must have a recent history of not responding well to topical medications, which are creams or ointments applied to the skin.
  • Participants must agree to apply a moisturizer at least once daily and use the approved topical therapy as directed by the study doctor.
  • Women who can have children must agree to use an effective method of birth control or practice true abstinence during the study and for 12 weeks after the last study drug injection.
  • Women who cannot have children must meet specific criteria, such as not having menstrual periods for 1 year or having had certain surgeries.
  • Participants and their guardians, if applicable, must be willing and able to follow all study requirements and schedules.
  • Participants and their guardians, if applicable, must understand and sign a consent form before any study procedures are done.
  • Participants must have had chronic atopic dermatitis for at least 2 years, confirmed by specific criteria.
  • Participants must have an EASI score of at least 16, which measures the severity of eczema.
  • Participants must have an IGA score of at least 3, which indicates moderate to severe eczema.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Individuals with other skin conditions that might interfere with the study, such as psoriasis or eczema not related to atopic dermatitis.
  • Participants who have used certain medications that could affect the study results, like strong steroids or immunosuppressants, within a specific time before the study starts.
  • People with a history of certain infections, such as tuberculosis, or those who have tested positive for certain viruses like HIV or hepatitis.
  • Women who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • Individuals with a history of drug or alcohol abuse, as this could affect their ability to follow the study procedures.
  • Patients with certain medical conditions that could make participation unsafe, such as severe heart, liver, or kidney disease.
  • Anyone who has participated in another clinical trial within a certain period before this study, to avoid interference with the results.
  • Individuals who are unable to comply with the study requirements, such as attending regular visits or following the treatment plan.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Medical University Of Vienna Vienna Austria
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Rotterdam The Netherlands
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Muenster AöR Munster Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Klinikum der Universitaet Muenchen AöR Munich Germany
Provita Sp. z o.o. Katowice Poland
Uniwersyteckie Centrum Kliniczne Gdansk Poland
University Medical Center Hamburg-Eppendorf Hamburg Germany
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario De La Princesa Madrid Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Centrum Badan Klinicznych Pi-House Sp. z o.o. Gdansk Poland
Hospital Universitario De Navarra Pamplona Spain
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Clintrial s.r.o. Prague Czechia
Praglandia s.r.o. Prague Czechia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Assistance Publique Hopitaux De Paris Paris France
Tartu University Hospital Tartu Estonia
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Synexus Polska Sp. z o.o. Poznan Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warsaw Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Martin-Luther-Universitaet Halle-Wittenberg Halle (Saale) Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Thermalsole und Schwefelbad Bentheim GmbH Bad Bentheim Germany
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Clinical Research Group Sp. z o.o. Warsaw Poland
MENSINGDERMAresearch GmbH Hamburg Germany
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain
EMC Instytut Medyczny S.A. Poznan Poland

Other Sites

Site Name City Country Status
Klinische Forschung Osnabrueck Osnabrück Germany
Alergo Med Osrodek Badan Klinicznych Sp. z o.o. Tarnow Poland
Synexus Polska Sp. z o.o. Warsaw Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
ProDerma Duelmen Institut fuer klinische Studien und innovative Dermatologie Duelmen Germany
Cgfdpaqrko Pfzffhztylh Lkjifelkiveqhgkrmrvmsxk Myzcvqgt siyvu Wroclaw Poland
Kkbporw Aiqsttgiy Skt z okak Warsaw Poland
Mbsmrnw Cwjlhr Edresjlum Oqy Sofia Bulgaria
Rvgoc 1q sshylahz Stt Riga Latvia
Pyngxw Fjqo Drhxugkljppb Uym Vtuyzbtedlp Dresden Germany
Dlstyymwwg Aks Ciojsxxsyo Cakndk Xmlzqnoosqev Ekdu Sofia Bulgaria
Mvynsfzuony Tukzqnpdddu Pvmykdj Etbz Sofia Bulgaria
Doqdvicoje Csopxagwwmvo Crisev 1y Ssscw Eswm Sofia Bulgaria
Amynfnojtyycegcgfxlfof Ctjmps Ebex Sofia Bulgaria
Vxsyikyb &mnxw Ppsc Od Tallin Estonia
Jltjllw Sde Riga Latvia
Vjswdzqh ui evepieua Sch Riga Latvia
Rvrpnab Utw Vilnius Lithuania
Cwtrwky Mppjwpzn Aaicrb Wroclaw Poland
Ldbgo Cvyers Sgey dy Terpls Kdrylcskude do Ahnbxow Kvmyvemo Szczecin Poland
Dbexnvna sqpqsn Povel Czechia
Shwfesi Cklxirb Mloyibkc Svh z odvj Poznan Poland
Aeyeyuimkpm Zh Sqtxkfpywgkcby Madybyfzwf Pydkorvilkqxkhg Padzgvpo Pf Drdgrvusojoz Cfbbwua Etrviswki Ofm Sofia Bulgaria
Ioydczwx Dtotxrjjwdiof Sun Gviuhimce &wxceha Iku (fuqvsz Rome Italy
Digdequwwwemiiippiur ogerinpt Mycff Bjuqde Hvjshaykjhf Pjkv Prague Czechia
Mqvjmhkywoesd Vtgewdyagzarosmznw Dmazudtur Gcrt Kiel Germany
Dkjsxymhaj Seg z omem Wroclaw Poland
Sek Wlfwvrancrlbx Gyxt Gkar Gera Germany
Enzx Kdaeuafj Sktprbcsbgjwiyh gmsmo Buxtehude Germany
Tcetw Pmxxfpdxuhe Sskypimvidoa Ccnlmyv Mydsmfpy Sbg z ofga Szczecin Poland
Cxohcrjb Bdze Szdziogvd Szw z ohjy Szfi Lublin Poland
Cvt Ozpaycm slrphv Moravska Ostrava A Privoz Czechia
Rwqvinpfw Rvrkrzbd Gomr Darmstadt Germany
Cvvrsck Mzpzpyaq Abhrotq Bdthpnt Kjubftzmz Cracow Poland
Idv Ijopgzqhrqagtgyxb Sywwy Abdbhcdfhoq Gvca Berlin Germany
Mzqapfetqrxzy Hjjmlsnn fjr Aojvpx Treklfavp Hqovd aro Bvawj Ejx Pleven Bulgaria
Cpkcvpb Zgxavgt I Ulxat Mzzfofi Lublin Poland
Dl Dfiotoj Rwuk Sfjghalxsmvp Martigues France
Mehnywn Bcw Veszprem Hungary
Muxkgqi Siyfcza Znjzmlqqv W Ofdvtsgkg Olsztyn Poland
Skiprdzbaj phhwvlbad Abefhtlaioc Prague Czechia
Hqiwoyehokt Fbwfqsdqhkfxdc – Deovmhunslef Berlin Germany
Stasg Awthq Pbtadrbv iz Dziwnlzfqehk Vgsgqypfmhb Talsi Latvia
Dqypqtgpkcbptvyzmvqtn Cbthguu smda Mibbczhors Jfqscammh Axjfsfcy Lodz Poland
Nncahcatukso Zwsxoe Oycgag Zzlupxamli Sjvpsaqfeqrsrdz Opnjvnt Dysvpcgysevrkts &cfjobzvvzkpatszdafq Sxqo Bialystok Poland
Rcounflph Atvkyxfkk Nyxcwdzh Warsaw Poland
Dksuzpbh Jdaqb Zuswehx Ostrowiec Swietokrzyski Poland
Dxididncas Mdjzhxr Deuvzinocht Ckwtab Ds ns mbeb Ehbzw Gfljjl Chorzow Poland
Dpvvbg Bktbgvgmlmrpx Hnicz Mos Pvlhjdquuvl Sgpbkjikuarwomk Warsaw Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
18.12.2019
Belgium Belgium
Not recruiting
18.12.2019
Bulgaria Bulgaria
Not recruiting
18.12.2019
Czechia Czechia
Not recruiting
18.12.2019
Estonia Estonia
Not recruiting
18.12.2019
France France
Not recruiting
18.12.2019
Germany Germany
Not recruiting
18.12.2019
Hungary Hungary
Not recruiting
18.12.2019
Italy Italy
Not recruiting
18.12.2019
Latvia Latvia
Not recruiting
18.12.2019
Lithuania Lithuania
Not recruiting
18.12.2019
Poland Poland
Not recruiting
18.12.2019
Spain Spain
Not recruiting
18.12.2019
The Netherlands The Netherlands
Not recruiting
18.12.2019

Trial locations

Investigated Drugs:

Nemolizumab (CD14152) is a medication being studied for its safety and effectiveness in treating moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. This trial aims to understand how well Nemolizumab works over a long period and to ensure it is safe for use in adults and adolescents with this skin condition.

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2024-514404-13-00
Protocol code:
RD.06.SPR.118163
NCT ID:
NCT03989206
Trial Phase:
Therapeutic confirmatory (Phase III)

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