A study to find out how well HZN-1116 works and how safe it is for participants with Sjögren's syndrome
Summary description of the study
The main purpose of this study is to find a safe and acceptable dose of a drug, HZN-1116, for individuals with SS. This study also aims to determine how well HZN-1116 works and whether it affects the signs and symptoms of SS, the organs affected by SS, and the quality of life. To assess the safety of HZN-1116, the investigators will monitor the number and severity of side effects experienced by participants at different dose levels. The study will also investigate how HZN-1116 is absorbed by the body, how the amount of HZN-1116 in the body changes over time, and whether the body shows an immune response to HZN-1116 (by forming antibodies against the drug, known as anti-drug antibodies). To find out how well HZN-1116 works, it will be compared to a placebo (a placebo is a substance that looks like HZN-1116 but contains no active ingredient). A total of 262 participants will take part in this study at approximately 105 trial centers worldwide. There are 2 different participant groups or "populations" in this study. "Population 1" includes about 100 participants who have a moderate to high number of extraglandular SS-related effects. "Population 2" includes about 162 participants who have fewer extraglandular SS-related effects but more severe self-reported SS symptoms.
(BASEC)
Intervention under investigation
HZN-1116 is an investigational substance being developed for the treatment of individuals with SS. It is not currently approved for the treatment of SS. HZN-1116 may help restore the balance of the immune system and reduce the symptoms of SS.
Participants will be randomly assigned to receive either HZN-1116 or a placebo (this is referred to as "randomization"). However, neither the participants nor the investigators will know which investigational product the participants receive (this is done "double-blind"). Approximately 60% of participants from Population 1 and 78% of participants from Population 2 will receive HZN-1116. All other participants will receive the placebo. The study will last approximately 65 weeks.
(BASEC)
Disease under investigation
Sjögren's syndrome (SS) is an autoimmune disease. In this condition, the immune system attacks the salivary and tear glands. This leads to dryness in the mouth and eyes. Other body parts besides the salivary and tear glands can also be affected ("extraglandular"), such as joints, skin, lungs, kidneys, liver, brain, and nerves. People with SS often feel very tired and have other health issues.
(BASEC)
Patients will be included in the study if they: • are 18 to 75 years old. • have SS. • have examination results showing how well their salivary and tear glands function. (BASEC)
Exclusion criteria
Patients will not be included in the study if they: • have previously received other (approved or still investigational) medications that could interfere with the investigational product. • have conditions that could interfere with the investigational product or put the participant at risk. • are allergic to certain medications or components of the investigational product. (BASEC)
Trial sites
St. Gallen
(BASEC)
Sponsor
Horizon Therapeutics Ireland DAC PPD Switzerland GmbH c/o Dufour Treuhand AG
(BASEC)
Contact
Contact Person Switzerland
Rebekah Stockwell
+1 847 910 1314
rstockwe@clutteramgen.comHorizon Therapeutics Ireland DAC
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
17.05.2024
(BASEC)
ICTRP Trial ID
NCT06312020 (ICTRP)
Official title (approved by ethics committee)
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome (BASEC)
Academic title
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjgren's Syndrome (ICTRP)
Public title
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome (ICTRP)
Disease under investigation
Sjogren's Syndrome (ICTRP)
Intervention under investigation
Drug: HZN-1116Drug: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
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. (ICTRP)
not available
Primary and secondary end points
Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1);Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2) (ICTRP)
Change from baseline in ESSDAI (Population #1);Proportion of Participants achieving ESSDAI [5] response (Population #1);Change from baseline in ESSPRI pain domain score (Population #1);Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1);Change from baseline in ESSPRI fatigue domain score (Population #1);Change from baseline in DASPRI fatigue domain score (Population #1);Change from baseline in ESSPRI dryness domain score (Population #1);Change from baseline in DASSPRI dryness domain score (Population #1);Change from baseline in tender joint count (TJC) (Population #1);Change from baseline in swollen joint count (SJC) (Population #1);Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1);Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1);Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1);Change from baseline in DASPRI (Population #2);Proportion of Participants achieving ESSPRI [1.5] response (Population #2);Change from baseline in ESSPRI pain domain (Population #2);Change from baseline in ESSPRI fatigue domain (Population #2);Change from baseline in ESSPRI dryness domain (Population #2);Change from baseline in SF-36 PCS Score (Population #2);Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2);Change from baseline in PROMIS-Fatigue SF-10a (Population #2);Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2);Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
MD;Amgen Call Center, medinfo@amgen.com, 866-572-6436, Amgen, (ICTRP)
Secondary trial IDs
HZNP-HZN-1116-201 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06312020 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available