Last updated 5 days ago
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
262 patients around the world
Available in Argentina, United States
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.
Amgen
6Research sites
262Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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.
- 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 who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.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.
Sites
DOM Centro de Reumatología - CABA
Recruiting
Centro Privado de Medicina Familiar
Recruiting
Mautalen - Salud e Investigación - CABA
Recruiting
Sanatorio 9 de Julio - Tucumán
Recruiting
Consultorios Médicos Dr. Doreski
Recruiting
MR Medicina Reumatológica
Recruiting
SponsorAmgen
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06312020
