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

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NCT06312020

Sponsored by Amgen (industry) · AMGN — their whole pipeline →.

Phase

Phase 2

Status

Terminated

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

209actual

Sites

Countries

Argentina, Austria, Chile +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

The study was terminated by sponsor due to meeting pre-defined criteria for futility.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-05-09

actual

When the study began enrolling

Primary completion

2026-04-28

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-04-28

actual

The whole study's end, after follow-up

First posted

2024-03-15

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-08

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Sjogren's Syndrome

Interventions

Drug: HZN-1116 — also filed as VIB1116, AMG 329
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)

measured At Week 48

Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)

measured At Week 24

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