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Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients

26 de mayo de 2026 actualizado por: Kristin Khan, University of Maryland, Baltimore

Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study

The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

15

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • UM Dermatology at UM Professional Building
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Kristin L Khan, MD
        • Sub-Investigador:
          • Carolyn Stolte, CRNP

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age 18-80
  • Diagnosis of Prurigo Nodularis (PN) for at least 1 year
  • Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
  • Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
  • Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug

Exclusion Criteria:

  • Prior participation in a lebrikizumab study
  • History of anaphylaxis
  • History of or active HIV
  • Active hepatitis or known liver cirrhosis
  • History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
  • Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
  • Current or recent parasitic infection
  • Immunocompromised individuals
  • Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
  • Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
  • Current or recent treatment with biologic drugs
  • Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study
  • Receipt of phototherapy or light-based therapy within 4 weeks before starting the study
  • Regular use of tanning booths or parlors within 4 weeks before starting the study
  • Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study
  • Recent use of an experimental drug

Other protocol-defined Inclusion/Exclusion Criteria apply.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lebrikizumab
Participants will receive subcutaneous injections of Lebrikizumab
Droga: Lebrikizumab
Participants will receive subcutaneous injections of Lebrikizumab every two weeks for 24 weeks. The first two doses will be 500 mg, and following doses will be 250 mg.
Otros nombres:
  • Ebglyss

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24
Periodo de tiempo: Baseline; Week 24
The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.
Baseline; Week 24
Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1
Periodo de tiempo: Baseline; Week 24
The percentage of patients achieving an IGA PN-S score of 0 or 1 with a ≥2-point reduction from baseline to Week 24. The IGA PN-S is a rating completed by the investigator during visits assessing the severity of the disease from 0 (Clear) to 4 (Severe)
Baseline; Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24
Periodo de tiempo: Baseline; Week 24
The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.
Baseline; Week 24
Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24
Periodo de tiempo: Baseline; Week 24
The DLQI is a 10-item questionnaire used to assess the impact of skin disease on the quality of life of the affected person. The 10 questions are scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Completed by participants during study visits specified in the protocol.
Baseline; Week 24
Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24
Periodo de tiempo: Baseline; Week 24
The SD-NRS is a single-item measure assessing sleep disturbance on a scale from 0 ("no sleep disturbance") to 10 ("worst possible sleep disruption"). Participants will complete the SD-NRS daily, rating their sleep quality.
Baseline; Week 24
Percent change from baseline in 5D-Pruritus Scale at week 24
Periodo de tiempo: Baseline; Week 24
5-D pruritus' scale is a questionnaire assessing duration, degree, direction, disability, and distribution of the affected person's itch. Completed by participants during study visits specified in the protocol.
Baseline; Week 24
Percent change from baseline in Prurigo Activity Score (PAS) at week 24
Periodo de tiempo: Baseline; Week 24
The PAS is a 7-item assessment completed by the investigator. The items of the PAS evaluate the type, number, distribution, size, and activity of skin lesions.
Baseline; Week 24
Percent change from baseline in HADS anxiety and depression scale at week 24
Periodo de tiempo: Baseline; Week 24
The Hospital Anxiety and Depression Survey is a questionnaire that evaluates and monitors mental health in adults. Completed by participants during study visits specified in the protocol.
Baseline; Week 24
Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24
Periodo de tiempo: Baseline; Week 24
The PGIC is a questionnaire assessing overall satisfaction and perceived change due to treatment, ranging from "very much improved" to "very much worse". Completed by participants during study visits specified in the protocol.
Baseline; Week 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Maryland, Baltimore

Colaboradores

Eli Lilly and Company

Investigadores

  • Investigador principal: Kristin L Khan, MD, University of Maryland, Baltimore

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • J2T-NS-X002

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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