Resumen

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Descripción detallada

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo. Acquired from Horizon in 2024.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
Have an ESSDAI score of \>= 5 at screening (only for Population 1).
Have an ESSPRI score of \>= 5 at screening (only for Population 2).
Have an ESSDAI score of \< 5 at screening (only for Population 2).
Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening.

Criterios de exclusión

Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.
Concomitant system sclerosis.
Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy.
Individuals who are pregnant or lactating or planning to become pregnant during the study.
Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded.
Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
Last administration of experimental biologic or oral agents \< 6 months or 5 half-lives, whichever is longer, before screening.
Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) \< 6 months before randomization.

Ubicaciones

MR Medicina Reumatologica

San Fernando, Buenos Aires, Argentina

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

HZN-1116

Placebo

Ubicaciones

MR Medicina Reumatologica

DOM Centro de Reumatología

Expertia S.A- Mautalén Salud e Investigación

Centro Privado de Medicina Familiar

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Patrocinadores