Resumen

Este es un estudio global de Fase 3 para evaluar la seguridad y eficacia de un fármaco en investigación (denominado PF-06651600) en adultos y adolescentes (de 12 años en adelante) con alopecia areata. Los pacientes elegibles de los estudios previos B7931005 (NCT02974868) y B7981015 (NCT03732807) tendrán la oportunidad de inscribirse, al igual que pacientes que no hayan participado anteriormente en ninguno de estos estudios. El estudio es abierto y todos los pacientes que ingresen recibirán el fármaco activo del estudio. Se realizará un subestudio con aproximadamente 60 pacientes adultos que participan en el estudio B7981032 en sitios seleccionados en EE. UU., Australia y Canadá. El subestudio evaluará la respuesta inmunitaria a las vacunas contra el tétanos y el meningococo en pacientes que hayan recibido un mínimo de 6 meses de PF-06651600 a 50 mg.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study:
Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
De novo participants \>=12 to \<18 years of age: \>=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
De novo participants \>=18 years of age and participants from Study B7931005 or B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study: \>=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
No evidence of terminal scalp hair regrowth within 6 months (de novo only)
Current episode of terminal scalp hair loss \<=10 years (de novo only)

Criterios de exclusión

For de novo participants and participants from Study B7931005 and B7981015 with \>30 days between first visit in B7981032 and last dose in the prior study:
Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1
\- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose \>12 weeks prior to the screening visit

Intervenciones

drug

PF-06651600

50 mg oral tablets/capsules

biological

Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

biological

Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

ESTUDIO DE FASE 3, ABIERTO, MULTICÉNTRICO Y A LARGO PLAZO PARA INVESTIGAR LA SEGURIDAD Y EFICACIA DE PF-06651600 EN PARTICIPANTES ADULTOS Y ADOLESCENTES CON ALOPECIA AREATA

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

PF-06651600

Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Ubicaciones

CINME Centro de Investigaciones Metabolicas

Psoriahue Medicina Interdisciplinaria

Patrocinadores