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Terminated/Withdrawn
Sponsor ID
HZNP-HZN-1116-201

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

Sponsor ID
HZNP-HZN-1116-201
Clinicaltrials.gov ID
NCT06312020
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
209
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: At Week 48

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

Timeframe: At Week 24

Secondary Outcome Measures

Change from baseline in ESSDAI (Population #1)

Timeframe: At Week 24

Proportion of Participants achieving ESSDAI [5] response (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in ESSPRI pain domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in ESSPRI fatigue domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in DASPRI fatigue domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in ESSPRI dryness domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in DASSPRI dryness domain score (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in tender joint count (TJC) (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in swollen joint count (SJC) (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)

Timeframe: At Week 24 and Week 48

Change from baseline in DASPRI (Population #2)

Timeframe: At Week 24

Proportion of Participants achieving ESSPRI [1.5] response (Population #2)

Timeframe: At Week 24

Change from baseline in ESSPRI pain domain (Population #2)

Timeframe: At Week 24

Change from baseline in ESSPRI fatigue domain (Population #2)

Timeframe: At Week 24

Change from baseline in ESSPRI dryness domain (Population #2)

Timeframe: At Week 24

Change from baseline in SF-36 PCS Score (Population #2)

Timeframe: At Week 24

Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)

Timeframe: At Week 24

Change from baseline in PROMIS-Fatigue SF-10a (Population #2)

Timeframe: At Week 24

Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)

Timeframe: Up to Week 60

Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)

Timeframe: Up to Week 60

Locations

Location
Status
Contact Us
Location
R & H Clinical Research - Katy - 1531 Westborough Dr
Katy, Texas, United States, 77449
Status
Recruiting
Location
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States, 33606-1246
Status
Recruiting
Location
Neurovations Research
Napa, California, United States, 94558-2415
Status
Recruiting
Location
DJL Clinical Research PLLC-431 N Wendover Rd
Charlotte, North Carolina, United States, 28211-1064
Status
Recruiting
Location
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305-2883
Status
Recruiting
Location
Altoona Center for Clinical Research - 175 Meadowbrook Ln
Duncansville, Pennsylvania, United States, 16635-8445
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
N/A
Condition
  • Sjögren’s Syndrome
    • Sex
    All
    Trial Dates
    May 2024 - Apr 2026
    Inclusion and Exclusion Criteria
    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.
    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.