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

Sjogren's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312020
• Other study ID #: HZNP-HZN-1116-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 9, 2024
• Est. completion date: November 26, 2026

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: November 26, 2026
• Est. primary completion date: September 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• HZN-1116
Subcutaneous Administration
• Placebo
Subcutaneous Administration

Locations

Country	Name	City	State
United States	DJL Clinical Research PLLC	Charlotte	North Carolina
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	West Tennessee Research Institute	Jackson	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)		At Week 48
Primary	Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)		At Week 24
Secondary	Change from baseline in ESSDAI (Population #1)		At Week 24
Secondary	Proportion of Participants achieving ESSDAI [5] response (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in ESSPRI pain domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in ESSPRI fatigue domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in DASPRI fatigue domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in ESSPRI dryness domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in DASSPRI dryness domain score (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in tender joint count (TJC) (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in swollen joint count (SJC) (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)		At Week 24 and Week 48
Secondary	Change from baseline in DASPRI (Population #2)		At Week 24
Secondary	Proportion of Participants achieving ESSPRI [1.5] response (Population #2)		At Week 24
Secondary	Change from baseline in ESSPRI pain domain (Population #2)		At Week 24
Secondary	Change from baseline in ESSPRI fatigue domain (Population #2)		At Week 24
Secondary	Change from baseline in ESSPRI dryness domain (Population #2)		At Week 24
Secondary	Change from baseline in SF-36 PCS Score (Population #2)		At Week 24
Secondary	Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)		At Week 24
Secondary	Change from baseline in PROMIS-Fatigue SF-10a (Population #2)		At Week 24
Secondary	Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)		Up to Week 60
Secondary	Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)		Up to Week 60