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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06312020
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sjogren's Syndrome
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: HZN-1116 Dose 1 in Population 1

Participants will receive Dose 1 of HZN-1116

Experimental: HZN-1116 Dose 2 in Population 1

Participants will receive Dose 2 of HZN-1116

Placebo Comparator: Placebo in Population 1

Participants will receive Placebo matched to HZN-1116

Experimental: HZN-1116 Dose 1 in Population 2

Participants will receive Dose 1 of HZN-1116

Experimental: HZN-1116 Dose 2 in Population 2

Participants will receive Dose 2 of HZN-1116

Experimental: HZN-1116 Dose 3 in Population 2

Participants will receive Dose 3 of HZN-1116

Experimental: HZN-1116 Dose 4 in Population 2

Participants will receive Dose 4 of HZN-1116

Placebo Comparator: Placebo in Population 2

Participants will receive Placebo matched to HZN-1116

Interventions

Drug: - HZN-1116

Subcutaneous Administration

Drug: - Placebo

Subcutaneous Administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Austin, Texas

Status

Recruiting

Address

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

Austin, Texas, 78745

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