Study of Rocatinlimab in Adults with Prurigo Nodularis Not Adequately Controlled by Topical Treatments

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What is this study about?

Prurigo Nodularis is a skin condition characterized by extremely itchy nodules (bumps) on the skin that appear due to chronic scratching. The condition can significantly affect quality of life through intense itching, skin pain, and sleep problems. This study will test a new medication called Rocatinlimab (also known as AMG 451) in adults who have not responded well to topical treatments or cannot use them.

The purpose of this research is to evaluate how well different doses of Rocatinlimab work compared to placebo in reducing itching in people with Prurigo Nodularis. The medication will be given as a subcutaneous injection (an injection under the skin). The study will last for 52 weeks, during which participants will receive either Rocatinlimab or placebo.

Throughout the study, participants will need to keep a daily record of their symptoms, including itching intensity and skin pain. Doctors will regularly examine the skin nodules and monitor how the treatment affects participants’ quality of life and sleep. The study will also track any side effects that may occur during the treatment period.

1 Initial assessment

Your eligibility for the study will be confirmed if you are 18 years or older and have been diagnosed with prurigo nodularis for at least 3 months

You must have at least 20 nodules distributed on both legs, arms, and/or trunk

Your condition must show inadequate response to previous topical treatments or these treatments must be unsuitable for you

2 Daily symptom recording

You will need to complete a daily electronic diary to record your itching symptoms

The diary must be completed for at least 4 days within the week before starting treatment

3 Treatment period

The study will last for 52 weeks (one year)

You will receive either rocatinlimab or a placebo through subcutaneous injection (injection under the skin)

The treatment aims to reduce itching and improve skin condition

4 Monitoring and assessment

Regular assessments will track changes in:

– Itching intensity

– Skin pain

– Quality of sleep

– Overall quality of life

– Skin lesion appearance

Any side effects or health changes will be documented throughout the study

Who Can Join the Study?

  • You must be at least 18 years old or meet the legal age requirement in your country if it is higher than 18
  • You must be willing to provide informed consent before starting any study procedures
  • You must have been diagnosed with prurigo nodularis for at least 3 months, with symptoms including:
    – Itching lasting more than 6 weeks
    – Signs of chronic scratching
    – Multiple itchy lesions and raised, scratched nodules (bumps) on the skin
  • You must report your daily itching severity using an electronic diary for 7 days before starting the study
  • You must have at least 20 nodules spread across both legs, both arms, and/or trunk
  • You must have either:
    – Not responded well to topical treatments (creams or ointments applied to the skin)
    – Cannot use topical treatments due to side effects or safety concerns
    – Previously used systemic treatments (medications taken by mouth or injection) or light therapy
  • You must complete at least 4 daily diary entries about your symptoms in the week before starting the study

Who Cannot Join the Study?

  • Prior treatment with rocatinlimab or any other investigational drug within 8 weeks before starting the study
  • Active or chronic infections, including tuberculosis or hepatitis B/C
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Significant heart problems or uncontrolled high blood pressure
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Current pregnancy or breastfeeding
  • Known allergic reactions to similar medications
  • Major surgery within 8 weeks before starting the study
  • Any condition that could interfere with study participation or increase risk to the participant
  • Use of other medications for treating prurigo nodularis that cannot be stopped during the study
  • Mental health conditions that could affect the ability to follow study procedures
  • Drug or alcohol abuse within the past 6 months
  • Participation in another clinical trial at the same time

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
Centre Hospitalier Universitaire Rouen Rouen France
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre Hospitalier Le Mans Le Mans France
Cjdowpugw Umrqjkytkgkxpk Sebqkhlst Woluwe-Saint-Lambert Belgium
Uplundzxhc Oh Drysxijy Debrecen Hungary
Cjhvsfcwps Pdotozhrfjw Lpfjqvbexwynngujglfidpz Mssstkta selep Wroclaw Poland
Uyscqvpvkgdazsemcjagd Tndendnal Anr Tuebingen Germany
Uvcyophojnxk Mylgfsp Cdgwpxn Uaifgtq Utrecht The Netherlands
Ujpemap Uxjddfayni Hwwcfzqv Uppsala Sweden
Uisxzsytuqyxkxdsunxkm Mrfaodva Ame Munster Germany
Uqzuxjymgd Om Sciczu Szeged Hungary
Cykwmz Hzccsvpupj Udacgtlainoqs Dw Sfmst Adgbrue Enpjbs Porto Portugal
Uetjhfwnrnjwit Cybgqku Ksugpzyqn Gdansk Poland
Himgvdvw Dx Lo Sswar Cklz I Sksx Phd Barcelona Spain
Ohensynlsmnziy Lbww Gboe Linz Austria
Cfwase hnbzjkgfpjo uxtssyrnswlgk da Lpatf Liege Belgium
Uingjzacajlaxkzgkbqgh Slunyoslasymecobji Auq Kiel Germany
Hvpbjers Uenfltglgwwms Do Ls Pbzggyin Madrid Spain
Fththsazl Pmlh Ly Itstbnxkashbu Bcslypqkj Ddp Hcrjwtkh Uhsmhcrudxark Lu Pjx Madrid Spain
Odaf Uwaoqkqoar Hkzxctmd Oulu Finland
Itmorpcrjc Gxwioub Hdtefrvj Ow Tlbnmtxberfc Thessaloniki Greece
Dehyhynt Rulfeqzz Klhz Oroshaza Hungary
Unbudsjgnl Gplyiep Hlvlupfr Axbcmib Gzhfcsx Hxenpivq Of Wjxt Apidkk H Arxr Vwjqunj Chaidari Greece
Dgdzjojjg Kvqt Kaposvar Hungary
Grsimrr Hibtvufl Oq Tnxavrdcwenq Pmknjpxwpccq Thessaloniki Greece
Dhnboakiptae Czyrrug Hsp i Setsft Av Stockholm Sweden
Jtrgcdy Snn Riga Latvia
Ozdias Eypifzfizwjps Cwqrbqq Kwqg Dunaújváros Hungary
Akivozu Sev z olkc Sjey Lodz Poland
Airmpof Shhakyc Hkiooshk Ob Vivdrxcj Ajg Dqhixaqscrceln Dlyhswey Athens Greece
Ubdrvqhbal Ob Pgfl Pecs Hungary
Cixlyhm Zkwtxdj Dtdiqzb I Rzsbcxd Irf Jcuy Pfviq Io W Sdngjsva Seo z oveb Sosnowiec Poland
Seynrlyh Cmdbra Jisgnuec Mimdm Targu Mures Romania
Dfsslgzfoi Std z otju Wroclaw Poland
Anwc Ffcwawutzwxdcrhl Slcdz Milan Italy
Uwhdwwqkzyelfjrpalehg Axnfizpq Augsburg Germany
Hmjdgqsh Cqq Dyxalmgmfko Skdv Lisbon Portugal
Tnvssrdyish uhr Sykafxcjhcy Biurfpal Gayg Bad Bentheim Germany
Cwyy Htdfkglh Of Helsinki Finland
Eq Hlwxbojx Usxijgwofbcag Dg Gqwx Ccfmlzb Dup Nhaptl Las Palmas De Gran Canaria Spain
Ramxuaakw Rbplsnpo Gbyu Darmstadt Germany
Aqzerlt Srfcukbdp Lvkjvi Atosmwvq Sgwojbi Ltjznpeymzblxs L'aquila Italy
Glddnsp Haatufiz Ow Nnb Ildym Keoivhoxdlwmobbv Pvhqiwjv Nea Ionia Greece
Dx Ddblvdy Rnuv Sqkagzmggubw Martigues France
Hzoiltrw Udrsbqqjxhaxd Hvgtgbie Tryfz y Pdwvvf Iqajxjbz Cnppie dxhychtftdmejqbfi (ginm Badalona Spain
Sdlogi Tnhnisdyoxr Of Turku Finland
Dofhriby Jgnfp Zdhotss Ostrowiec Swietokrzyski Poland
Higxuelbaxamra Ddjsttoq Mlnzpjcyw Remscheid Germany
Rlxhfafnq Avhvrgatd Njwawufc Warsaw Poland
Nojonfskgkbz Zpcgke Owdwjo Zhrpozehxu Sruukqntuaudrit Otlhipn Dsrfyeuznzdydsk &bjsdngmoevmxbmvpyft Bialystok 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
22.12.2024
Belgium Belgium
Not recruiting
22.12.2024
Finland Finland
Not recruiting
22.12.2024
France France
Not recruiting
22.12.2024
Germany Germany
Not recruiting
22.12.2024
Greece Greece
Not recruiting
22.12.2024
Hungary Hungary
Not recruiting
22.12.2024
Italy Italy
Not recruiting
22.12.2024
Latvia Latvia
Not recruiting
22.12.2024
Poland Poland
Not recruiting
22.12.2024
Portugal Portugal
Not recruiting
22.12.2024
Romania Romania
Not recruiting
22.12.2024
Spain Spain
Not recruiting
22.12.2024
Sweden Sweden
Not recruiting
22.12.2024
The Netherlands The Netherlands
Not recruiting
22.12.2024

Trial locations

Investigated Drugs:

Rocatinlimab is an investigational medication being studied for treating prurigo nodularis, a skin condition that causes intense itching and nodules on the skin. This medication is designed to help patients who haven’t responded well to topical treatments (creams or ointments applied to the skin) or who cannot use topical treatments. It works by targeting specific components of the immune system that are involved in causing the intense itching and skin lesions associated with prurigo nodularis.

Topical therapies refer to various creams, ointments, or lotions that are applied directly to the skin to treat prurigo nodularis. These are standard treatments that patients may have used before trying rocatinlimab.

Prurigo Nodularis – A chronic skin condition characterized by hard, itchy nodules (bumps) that develop on the skin. The condition typically begins with an intense itching sensation that leads to scratching, which then causes the formation of firm, dome-shaped bumps on the skin’s surface. These nodules commonly appear on the arms, legs, upper back, and abdomen. The affected areas often become rough and thickened due to repeated scratching. The condition can persist for months or years, with periods of improvement and worsening. The itching associated with Prurigo Nodularis can be severe and often interferes with daily activities and sleep.

Trial ID:
2024-510753-10-00
Protocol code:
20230053
NCT ID:
NCT06527404
Trial Phase:
Therapeutic confirmatory (Phase III)

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