Estudio de rango de dosis de fase 2b, multicéntrico, alea... | EligiMed

Estudio de rango de dosis de fase 2b, multicéntrico, aleatorizado, doble ciego, controlado con placebo y con control activo, para evaluar la eficacia y seguridad de JNJ-95475939 para el tratamiento de participantes con dermatitis atópica moderada a grave

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06881251Tipo: INTERVENTIONALInicio: 26 de feb de 2025Fin estimado: 26 de mar de 2026

Resumen

El propósito de este estudio es evaluar la eficacia de JNJ-95475939 en comparación con placebo en participantes con dermatitis atópica moderada a grave.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
\>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit

Criterios de exclusión

Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study

Intervenciones

drug

Dupilumab

Dupilumab will be administered subcutaneously.

drug

JNJ-95475939

JNJ-95475939 will be administered subcutaneously.

drug

Placebo

Placebo will be administered subcutaneously.

Ubicaciones

CIPREC

Buenos Aires, Argentina

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Argentina

Derma Internacional S A

Buenos Aires, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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