Terminado antes de tiempoNCT01987492Registro de ClinicalTrials.gov

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Asthma

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 12 años - 75 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 230 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Por qué se detuvo el estudio

Sponsor decision to discontinue lebrikizumab development for the treatment of asthma.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Severe asthma despite intensive follow-up by an asthma specialist for \>/=6 months prior to Visit 1
Baseline forced expiratory volume in 1 second (FEV1) \>/=40% of predicted prior to randomization
Receiving high doses of inhaled glucocorticosteroids at a total daily dose of \>/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
Chronic treatment with maintenance OCS for \>/=6 months prior to Visit 1
Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance

Exclusion Criteria:

History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
For adolescents: History of active tuberculosis requiring treatment
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known current malignancy or current evaluation for a potential malignancy
History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
Current smoker or former smoker with a smoking history of more than 15 pack-years
Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
Use of a licensed or investigational monoclonal antibody other than anti-interleukin (IL)-13 or anti-IL-4/IL-13, including but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento doble

Lebrikizumab High Dose

Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.

Drug: Lebrikizumab

Lebrikizumab Low Dose

Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.

Drug: Lebrikizumab

Placebo

Participants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period. Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.

Drug: Lebrikizumab · Drug: Placebo

Lebrikizumab DRUG

Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.

Placebo DRUG

Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose at Week 44

Plazo: Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)

OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an electronic diary (eDiary) on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the electronic Case Report Form (eCRF). Baseline OCS dose was calculated using the eDiary as average daily dose over 28 days prior to randomization. Post-baseline OCS dose was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. Percent change = (post-baseline value - baseline value)/baseline value \* 100.

Medidas secundarias

Absolute Change From Baseline in Daily OCS Dose at Week 44

Plazo: Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)

OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an eDiary on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the eCRF. Baseline OCS dose was calculated using the eDiary as average daily dose over 28 days prior to randomization. Post baseline OCS dose was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint.

Percent Change From Week 12 in Daily OCS Dose at Week 44

Plazo: Week 12 (including 28 days prior to Week 12), Week 44 (including 28 days prior to Week 44)

OCS used in study: prednisone/prednisolone. Participants entered their total daily use of OCS into an eDiary on a daily basis. The OCS intake since the previous study visit and the prescribed OCS dose for the next 28 days was captured by physician on a dedicated page in the eCRF. OCS dose at a timepoint was obtained from the eCRF and calculated as average daily dose over the 28 days preceding the timepoint. Percent change = (value at Week 44 - value at Week 12)/value at Week 12 \* 100. Reported values are adjusted mean values obtained from MMRM analysis.

Percentage of Participants Who Achieved at Least a 50 Percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline

Plazo: Baseline (including 28 days prior to Day 1), Week 44 (including 28 days prior to Week 44)

Percentage of Participants Who Either Discontinued OCS Therapy or Achieved an Adrenal Maintenance Dose at Week 44

Plazo: Week 44

Percentage of participants who either discontinued OCS therapy or have achieved an adrenal maintenance dose is reported. Identification of participants achieving adrenal maintenance dose was based on physician assessment recorded in eCRF in the presence of cortisol = 100 nanomoles per liter (nmol/L). The 95% CI for the percentage was based on normal approximation for binomial proportion.

Rate of Asthma Exacerbations During the 44-Week Double-Blind Placebo Controlled (DBPC) Period

Plazo: Baseline up to Week 44

An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalization. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least 1 dose of IV or IM corticosteroids. Rate of asthma exacerbation = total number of exacerbation events divided by total follow-up time in patient years.

Hay resultados publicados en el registro.

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Centros de investigación (45)

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45 centros

Allergy & Asthma Care Center of Southern CaliforniaLong Beach, California, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (45)

Equipo y fechas

Contactos oficiales del estudio

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