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
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Clinmedica Research sp. z o.o. Skierniewice Poland
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Amicare Sp. z o.o. S.K. Lodz Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Centre Hospitalier Universitaire De Nice Nice France
University Of Szeged Szeged Hungary
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Spitalul Clinic Judetean Mures Targu Mures Romania
ASST Fatebenefratelli Sacco Milan Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Hospital Cuf Descobertas S.A. Lisbon Portugal
CRST Helsinki Oy Helsinki Finland
Oulu University Hospital Oulu Finland
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Rosenpark Research GmbH Darmstadt Germany
General Hospital Of Nea Ionia Konstantopouleio Patision Nea Ionia Greece
Du Docteur Ruer S.E.L.A.R.L. Martigues France
DermaMed Research Kft. Oroshaza Hungary
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL Bialystok Poland
Hautarztpraxis Dariusch Mortazawi Remscheid Germany
Royalderm Agnieszka Nawrocka Warsaw Poland
Cocqeqnhs Uxmuympkkwoqxs Sjjxaazzb Woluwe-Saint-Lambert Belgium
Dfvztewmb Kzua Kaposvar Hungary
Jzdgydg Swg Riga Latvia
Upjmasx Ubsbewzggr Hgzadhnu Uppsala Sweden
Uvobkopcduampzwcchtie Mzfwhgts Ajl Munster Germany
Uringnyedloxxw Cltkbgh Kqdoogvyv Gdansk Poland
Dktsahftrj Svw z okue Wroclaw Poland
Hokcwvxj Dk Ln Sjvtk Ctmc I Sloc Pfn Barcelona Spain
Oqxrnajoucotag Lojp Gyqe Linz Austria
Hcjvuyto Udsaqebmfelqf Db Lg Pyuonrjm Madrid Spain
Uyxynutclortjwuaqgnvq Acyflrra Augsburg Germany
Fibrthwhr Pqxs Lu Ivqvjshuaxuui Bdnkhludf Dlp Htruqaow Uphskwgrygtcy Lh Pqt Madrid Spain
Tqpsrsmvtkr usi Symdbngdbfa Brfftzxb Galq Bad Bentheim Germany
Adwxckg Snaqkdihz Lrmdqk Ahtxuxyl Slisxkv Lmihiieyfefaip L'aquila Italy
Honczjhf Ulknclwpklyzt Hucrhknu Tihaf y Phlxjx Iksvexlu Ccmkei dcyihpqmqvsweabfp (zybf Badalona Spain
Dlxvjvvwmkip Cylcewe Hdz i Sbllvm Av Stockholm Sweden
Sspsew Tuuwelsdmwj Ox Turku Finland

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.

Investigated diseases:

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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