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A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

NCT06312020

TerminatedPhase 2

Sponsor: Amgen

Conditions: Sjogren's Syndrome

Interventions: HZN-1116, Placebo

Countries: United States, Argentina, Austria, Chile, Colombia, France, Germany, Hungary

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.
Locations (66)
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Napa, California, United States
  • Miami, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Augusta, Georgia, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • Jackson, Tennessee, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • Katy, Texas, United States
  • Madison, Wisconsin, United States
  • San Fernando, Buenos Aires, Argentina
  • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
  • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
  • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
  • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
  • Graz, Styria, Austria
  • Temuco, Araucania, Chile
  • Providencia, Región-MetropolitanadeSantiago, Chile
  • Santiago, Región-MetropolitanadeSantiago, Chile
  • Viña del Mar, Valparaiso, Chile
  • Barranquilla, Atlántico, Colombia
  • Zipaquirá, Cundinamarca, Colombia
  • Bucaramanga, Colombia
  • Medellín, Colombia
  • + 36 more on CT.gov