A Phase 3, 52-Week, Multicenter, Randomized, Placebo-cont... | EligiMed

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06527404Tipo: INTERVENTIONALInicio: 18 de jul de 2024Fin estimado: 17 de ene de 2027

Traducción no disponible, mostrando original

Resumen

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Intervenciones

drug

Rocatinlimab

SC Injection

drug

Placebo

SC Injection

Ubicaciones

Hospital Universitario Austral

Derqui, Pilar, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Cordoba

Córdoba, Córdoba Province, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, Argentina

Derma Internacional

Buenos Aires, Distrito Federal, Argentina

Centro de investigacion clinica y epidemiologica

San Miguel D Tucuman, Tucumán Province, Argentina

Parra Dermatologia

Mendoza, Argentina

Patrocinadores

PrincipalAmgen

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