Estudio de fase 2, aleatorizado, doble ciego, controlado ... | EligiMed

Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico para evaluar la seguridad y eficacia de tarperprumig en participantes adultos con vasculitis asociada a anticuerpos anticitoplasma de neutrófilos (I TRANSCEND)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07160608Tipo: INTERVENTIONALInicio: 26 de nov de 2025Fin estimado: 9 de feb de 2028

Resumen

El objetivo primario de este estudio es evaluar la seguridad y tolerabilidad de tarperprumig en participantes con vasculitis asociada a anticuerpos anticitoplasma de neutrófilos (ANCA) de diagnóstico reciente o en recaída.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered.
Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay).
At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS.

Criterios de exclusión

Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease.
Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study.
For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.

Intervenciones

drug

Placebo

Participants will receive placebo.

drug

Tarperprumig

Participants will receive tarperprumig.

Ubicaciones

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

La Plata, Argentina

RECRUITING

Research Site

Rosario, Argentina

RECRUITING

Research Site

San Juan Bautista, Argentina

RECRUITING

Research Site

Santa Fe, Argentina

WITHDRAWN

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

Contactos

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

clinicaltrials@alexion.com 1-855-752-2356

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