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Investigating HZN-1116 for Sjogren's Syndrome

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

Phase 2 Interventional Amgen · NCT06312020

This study is testing a new treatment called HZN-1116 to see if it can help people with Sjogren's syndrome who have either moderate to high disease activity or significant symptoms.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment262 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsrituximab, ocrelizumab, inebilizumab, ofatumumab, belimumab, anifrolumab
Locations84 sites (Glendale, Arizona and 83 other locations)
Trial IDNCT06312020 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of HZN-1116 in individuals diagnosed with Sjogren's syndrome. It will enroll two populations: one with moderate to high systemic disease activity and another with moderate to severe subjective symptoms. Participants will undergo a screening phase followed by a 48-week treatment period where they will be randomized to receive either HZN-1116 or a placebo. A follow-up period of 12 weeks will assess the outcomes of the treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Sjogren's syndrome who meet specific criteria related to disease activity and symptoms.

Not a fit: Patients with concomitant systemic sclerosis or active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Sjogren's syndrome.

How similar studies have performed: Previous studies have shown promise in treating autoimmune diseases with similar approaches, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Glendale, Arizona and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sjogren's SyndromeSSSjogren'sHZN-1116Autoimmune diseaseDry Eye syndromeVIB1116
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.