A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06754462Tipo: INTERVENTIONALInicio: 10 de ene de 2025Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

Descripción detallada

The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28. The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and Female participants of age \>18 years will be enrolled.
Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen joint count (SJC) at both Screening and Baseline visits.
C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.
Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
Inadequate response to at least 2 classes of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

Criterios de exclusión

History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA.
Have received rituximab and experienced insufficient efficacy or loss of efficacy
Active malignancy or history of malignancy within 5 years prior to Screening Visit.
Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
Used any nonimmunosuppressive fragment crystallizable (Fc)-based therapeutic protein (e.g., monoclonal antibody \[mAb\] or Fc-fusion protein) within 4 weeks prior to or at Screening Visit.
Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.

Intervenciones

drug

IMVT-1402

Administered once weekly by subcutaneous injection.

drug

Placebo

Administered once weekly by subcutaneous injection.

Ubicaciones

Site Number - 5003

Buenos Aires, Argentina

Site Number - 5001

Buenos Aires, Argentina

Site Number -5004

Buenos Aires, Argentina

Site Number - 5002

Buenos Aires, Argentina

Site Number - 5005

Buenos Aires, Argentina

Site Number - 5000

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalImmunovant Sciences GmbH

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