ACTIVE_NOT_RECRUITING

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

Conditions

Sjogren's Syndrome SS Sjogren's HZN-1116 Autoimmune disease Dry Eye syndrome VIB1116

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-05-09

Study Completion:2026-11-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06312020

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, Arizona, 85210-6871

United States

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, 85032-9306

United States

Neurovations Research

Napa, California, 94558-2415

United States

Life Arc Research Centers Corp

Miami, Florida, 33126

United States

IRIS Research and Development LLC

Plantation, Florida, 33324-2736

United States

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606-1246

United States

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia, 30912-0004

United States

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, 02111-1552

United States

Pioneer Clinical Research NY

New York, New York, 10016-7313

United States

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, 28211-1064

United States

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, 16635-8445

United States

West Tennessee Research Institute

Jackson, Tennessee, 38305-2883

United States

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

Austin, Texas, 78745

United States

Prolato Clinical Research Center

Houston, Texas, 77054-2853

United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas, 77450-2297

United States

University Of Wisconsin - Madison

Madison, Wisconsin, 53792-0001

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-09

Study Completion Date2026-11-24

Study Record Updates

Study Start Date2024-05-09

Study Completion Date2026-11-24

Terms related to this study

Keywords Provided by Researchers

SS
Sjogren's
HZN-1116
Autoimmune disease
Dry Eye syndrome
VIB1116

Additional Relevant MeSH Terms

Sjogren's Syndrome