Last updated 12 days ago
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
460 patients around the world
Available in Chile
Amgen
2Research sites
460Patients around the world
This study is for people with
Prurigo nodularis
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years).Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1.Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and/or arms and/or trunk.History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).Prurigo nodularis secondary to medications.Prurigo nodularis secondary to neurologic or psychiatric medical conditions.Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.
Sites
Instituto de Investigaciones Clínicas Córdoba
Centro Internacional de Estudios Clínicos - CIEC
Recruiting
SponsorAmgen
Study typeInterventional
Conditions
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06527404
