A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05090891Tipo: INTERVENTIONALInicio: 5 de may de 2022Fin estimado: 20 de ene de 2033

Traducción no disponible, mostrando original

Resumen

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Female and male participants:
Cohort 1: ≥ 12 years of age.
Cohort 2: 6 to \< 12 years of age.
Cohort 3: 2 to \< 6 years of age (after eDMC review of interim data from Cohort 2).
Clinical diagnosis of FOP.
Willingness to avoid pregnancy or fathering children based on the criteria below.
Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.

Criterios de exclusión

Pregnant or breast-feeding.
CAJIS score ≥ 24.
FOP disease severity that in the investigator's opinion precludes participation.
Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
HIV, HBV, or HCV infection. Note:

Intervenciones

drug

INCB000928

INCBG000928 will be administered QD orally.

drug

Placebo

Placebo will be administered QD orally.

Ubicaciones

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled S... | EligiMed