Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06312020 | RECRUITING | Sjogren's Syndrome

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

Amgen

Brief Summary:

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

Condition or disease

Sjogren's Syndrome

Intervention/treatment

HZN-1116

Placebo

Phase

PHASE2

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 262 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome
Actual Study Start Date : 2024-05-09
Estimated Primary Completion Date : 2026-06-02
Estimated Study Completion Date : 2027-02-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Location Details

NCT06312020

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln

Glendale, arizona, United States, 85306-9800

RECRUITING

United States, Arizona

Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, arizona, United States, 85210-6871

RECRUITING

United States, California

Neurovations

Napa, California, United States, 94558-2415

RECRUITING

United States, Florida

Life Arc Research Centers Corp

Miami, Florida, United States, 33126

RECRUITING

United States, Florida

Millennium Research

Ormond Beach, Florida, United States, 32174-1140

RECRUITING

United States, Florida

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States, 33606-1246

RECRUITING

United States, Louisiana

Accurate Clinical Research - Lake Charles

Lake Charles, Louisiana, United States, 70605-5393

RECRUITING

United States, Maryland

Columbia Medical Practice

Columbia, Maryland, United States, 21045

RECRUITING

United States, New York

Pioneer Clinical Research NY

New York, New York, United States, 10016-7313

RECRUITING

United States, North Carolina

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, United States, 28211-1064

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, United States, 16635-8445

RECRUITING

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305-2883

RECRUITING

United States, Texas

Tekton Research, LLC - W Gate Blvd - Austin - PPDS

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Trio Clinical Trials - 1235 North Loop West

Houston, Texas, United States, 77008-1772

RECRUITING

United States, Texas

Prolato Clinical Research Center

Houston, Texas, United States, 77054-2853

RECRUITING

United States, Texas

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States, 77450-2297

RECRUITING

Argentina, Autonomous City of Buenos Aires

Private Family Medicine Center

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1417

RECRUITING

Switzerland,

St. Gallen Cantonal Hospital

St Gallen, Switzerland, 9007