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

Description

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

Conditions

Sjogren's Syndrome

Study Overview

Study Details

Study overview

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

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

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

Condition
Sjogren's Syndrome
Intervention / Treatment

-

Contacts and Locations

Glendale

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln, Glendale, Arizona, United States, 85306-9800

Mesa

Arizona Arthritis & Rheumatology Research-S Vineyard Ave, Mesa, Arizona, United States, 85210-6871

Napa

Neurovations, Napa, California, United States, 94558-2415

Miami

Life Arc Research Centers Corp, Miami, Florida, United States, 33126

Ormond Beach

Millennium Research, Ormond Beach, Florida, United States, 32174-1140

Plantation

IRIS Research and Development LLC, Plantation, Florida, United States, 33324-2736

Tampa

Clinical Research of West Florida Inc - Tampa, Tampa, Florida, United States, 33606-1246

Lake Charles

Accurate Clinical Research - Lake Charles, Lake Charles, Louisiana, United States, 70605-5393

Columbia

Columbia Medical Practice, Columbia, Maryland, United States, 21045

Boston

Tufts Medical Center - 800 Washington St - PPDS, Boston, Massachusetts, United States, 02111-1552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-02-09