A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syn… (NCT06312020) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
Stopped: The study was terminated by sponsor due to meeting pre-defined criteria for futility.
United States209 participantsStarted 2024-05-09
Plain-language summary
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 his…
What they're measuring
1
Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)
Timeframe: At Week 48
2
Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)