A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04006457RENIS: IS003821Tipo: INTERVENTIONALInicio: 18 de jul de 2019Fin estimado: 1 de mar de 2026

Traducción no disponible, mostrando original

Resumen

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

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

Ubicaciones

CINME Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Psoriahue Medicina Interdisciplinaria

CABA, Argentina

Patrocinadores

PrincipalPfizer

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