Resumen

Objetivo primario: Demostrar la eficacia de dupilumab sobre la respuesta al prurito en participantes con prurigo nodular (PN) con control inadecuado con terapias tópicas de prescripción o cuando dichas terapias no son aconsejables. Objetivos secundarios: Demostrar la eficacia de dupilumab sobre variables adicionales del prurito en participantes con PN con control inadecuado con terapias tópicas de prescripción o cuando dichas terapias no son aconsejables. Demostrar la eficacia de dupilumab sobre las lesiones cutáneas del PN. Demostrar la mejoría en la calidad de vida relacionada con la salud. Evaluar las medidas de resultado de seguridad. Evaluar la inmunogenicidad de dupilumab.

Descripción detallada

La duración del estudio para cada participante incluyó un período de selección de 2 a 4 semanas, un período de tratamiento de 24 semanas y un período posterior al tratamiento de 12 semanas.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Must be 18 to 80 years of age, at the time of signing the informed consent.
With a clinical diagnosis of PN defined by all of the following:
Diagnosed by a dermatologist for at least 3 months before the screening visit.
On the worst-Itch Numeric Rating Scale (WI-NRS) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (\>=) 7 in the 7 days prior to Day 1.
Participants who had a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at screening visit and Day 1.
History of failing a 2-week course of medium-to-superpotent TCS or when TCS were not medically advisable.
Had applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.
Was willing and abled to complete a daily symptom electronic-diary for the duration of the study.

Criterios de exclusión

Participants were excluded from the study if any of the following criteria apply:
Presence of skin morbidities other than PN and mild atopic dermatitis (AD) that interfered with the assessment of the study outcomes.
PN secondary to medications.
PN secondary to medical conditions such as neuropathy or psychiatric disease.
Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit.
Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
Severe renal conditions (eg, participants with uremia and/or on dialysis).
Participants with uncontrolled thyroid disease.
Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment had ruled out active infection before randomization.
Active chronic or acute infection (except human immunodeficiency virus infection) required treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
Known or suspected immunodeficiency.
Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

drug

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

drug

Moisturizers

Pharmaceutical form: Route of administration: Topical

drug

Low to medium potent topical corticosteroids

Pharmaceutical form: Route of administration: Topical

drug

Topical calcineurin inhibitors

Pharmaceutical form: Route of administration: Topical

Ubicaciones

Investigational Site Number :0320008

CABA, Buenos Aires, Argentina

Investigational Site Number :0320005

CABA, Buenos Aires, Argentina

Investigational Site Number :0320002

CABA, Buenos Aires, Argentina

Investigational Site Number :0320004

CABA, Buenos Aires F.D., Argentina

Investigational Site Number :0320007

CABA, Buenos Aires F.D., Argentina

Investigational Site Number :0320003

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number :0320001

Buenos Aires, Argentina

Investigational Site Number :0320006

Caba, Argentina

Investigational Site Number :0320009

Mendoza, Argentina

Estudio de grupos paralelos, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de dupilumab en pacientes con prurigo nodular con control inadecuado con terapias tópicas de prescripción o cuando dichas terapias no son aconsejables

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab SAR231893

Placebo

Moisturizers

Low to medium potent topical corticosteroids

Topical calcineurin inhibitors

Ubicaciones

Investigational Site Number :0320008

Investigational Site Number :0320005

Investigational Site Number :0320002

Investigational Site Number :0320004

Investigational Site Number :0320007

Investigational Site Number :0320003

Investigational Site Number :0320001

Investigational Site Number :0320006

Investigational Site Number :0320009

Patrocinadores