Clinical Trials List
Protocol NumberHZNP-HZN-1116-201
Active
2024-07-01 - 2027-01-31
Phase II
Not yet recruiting1
Recruiting4
ICD-10M35.00
Sicca syndrome, unspecified
ICD-10M35.01
Sicca syndrome with keratoconjunctivitis
ICD-10M35.09
Sicca syndrome with other organ involvement
ICD-9710.2
Sicca syndrome
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome
-
Sponsor
Horizon Therapeutics Ireland DAC
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 呂政勳 風濕免疫科
- 郭佑民 風濕免疫科
- KO-JEN LI 風濕免疫科
- 鄭喬峰 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
- TSO-TING LAI Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張哲慈 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chi-Ching Chang
Co-Principal Investigator
- Tzn-Min Lin
- 張克宇 風濕免疫科
- 林科宏
- 李向嚴
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Sjögren’s Syndrome
Objectives
Population #1:
To evaluate the effect of HZN-1116 on
systemic manifestations of Sjӧgren’s
Syndrome (SS) in participants with
moderate-to-severe systemic disease
activity
Test Drug
injection
Active Ingredient
HZN-1116
Dosage Form
243
Dosage
100 mg / vial
Endpoints
Population #1:
Change from baseline in European
Alliance of Associations for
Rheumatology Sjögren’s Syndrome
Disease Activity Index (ESSDAI) total
score at Week 48
Change from baseline in European
Alliance of Associations for
Rheumatology Sjögren’s Syndrome
Disease Activity Index (ESSDAI) total
score at Week 48
Inclution Criteria
To be included in this study, each participant must satisfy all of the following criteria (note
inclusion criteria specific to Population #1 or specific to Population #2):
1. Adults, ≥ 18 and ≤ 75 years of age at time of informed consent (the minimum age for adult
participants can be > 18 years of age based on country-specific regulations). Participants
must be capable of providing their own informed consent.
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria. If SS
diagnosis based on positive anti-Ro autoantibody, anti-Ro positivity must be confirmed by
central lab.
3. Population #1 only:
a. Have an ESSDAI score of ≥ 5 at screening despite symptomatic (eg, nonsteroidal
anti-inflammatory drugs [NSAIDs]) or local therapy at screening. The following
domains will be scored but they will not contribute to the minimum ESSDAI score of
5 required for inclusion as these domains may have lower sensitivity to change over
duration of trial: peripheral nervous system, central nervous system, and pulmonary.
Population #2 only:
a. Have an ESSPRI score of ≥ 5 at screening.
b. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as
per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min
or with residual lacrimal gland function defined as an unanesthetized Schirmer’s test
≥ 1 mm/5 min.
6. Females of childbearing potential who are sexually active with a nonsterilized male partner
must use a highly effective method of contraception from signing the informed consent form
(ICF) and must agree to continue using such precautions through the end of the study (or
15 weeks after the last dose of IP administration, if participant withdraws from study) and
refrain from ova donation during this period; cessation of contraception after this point
should be discussed with a responsible physician.
7. Nonsterilized male participants who are sexually active with a female partner of childbearing
potential must use a condom with spermicide (unless spermicide is not available or restricted
per local regulations) from Day 1 through the end of the study and refrain from sperm
donation during this period and for 15 weeks after the last dose of IP administration.
8. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the United States [US], European Union [EU] General
Data Protection Regulation [GDPR] in the EU) obtained from the participant prior to
performing any protocol-related procedures, including screening evaluations.
9. Fully vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
according to current local authority guidelines, if any, at least 2 weeks prior to screening
unless individual refuses vaccination. Initial or subsequent coronavirus disease 2019
(COVID-19) vaccine administration is permitted during the study as long as it is not
administered during the screening period or within 2 weeks after Dose 1; if vaccine is to be
administered during this window, screening should be delayed to complete vaccination.
10. Meets all of the following tuberculosis (TB) criteria:
a. No history of latent or active TB prior to screening, except for latent TB with
documented completion of locally appropriate treatment.
b. No signs or symptoms suggestive of active TB from medical history or physical
examination.
inclusion criteria specific to Population #1 or specific to Population #2):
1. Adults, ≥ 18 and ≤ 75 years of age at time of informed consent (the minimum age for adult
participants can be > 18 years of age based on country-specific regulations). Participants
must be capable of providing their own informed consent.
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria. If SS
diagnosis based on positive anti-Ro autoantibody, anti-Ro positivity must be confirmed by
central lab.
3. Population #1 only:
a. Have an ESSDAI score of ≥ 5 at screening despite symptomatic (eg, nonsteroidal
anti-inflammatory drugs [NSAIDs]) or local therapy at screening. The following
domains will be scored but they will not contribute to the minimum ESSDAI score of
5 required for inclusion as these domains may have lower sensitivity to change over
duration of trial: peripheral nervous system, central nervous system, and pulmonary.
Population #2 only:
a. Have an ESSPRI score of ≥ 5 at screening.
b. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as
per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min
or with residual lacrimal gland function defined as an unanesthetized Schirmer’s test
≥ 1 mm/5 min.
6. Females of childbearing potential who are sexually active with a nonsterilized male partner
must use a highly effective method of contraception from signing the informed consent form
(ICF) and must agree to continue using such precautions through the end of the study (or
15 weeks after the last dose of IP administration, if participant withdraws from study) and
refrain from ova donation during this period; cessation of contraception after this point
should be discussed with a responsible physician.
7. Nonsterilized male participants who are sexually active with a female partner of childbearing
potential must use a condom with spermicide (unless spermicide is not available or restricted
per local regulations) from Day 1 through the end of the study and refrain from sperm
donation during this period and for 15 weeks after the last dose of IP administration.
8. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the United States [US], European Union [EU] General
Data Protection Regulation [GDPR] in the EU) obtained from the participant prior to
performing any protocol-related procedures, including screening evaluations.
9. Fully vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
according to current local authority guidelines, if any, at least 2 weeks prior to screening
unless individual refuses vaccination. Initial or subsequent coronavirus disease 2019
(COVID-19) vaccine administration is permitted during the study as long as it is not
administered during the screening period or within 2 weeks after Dose 1; if vaccine is to be
administered during this window, screening should be delayed to complete vaccination.
10. Meets all of the following tuberculosis (TB) criteria:
a. No history of latent or active TB prior to screening, except for latent TB with
documented completion of locally appropriate treatment.
b. No signs or symptoms suggestive of active TB from medical history or physical
examination.
Exclusion Criteria
To be included in this study, each participant must not meet any of the following criteria (note
exclusion criteria specific to Population #1 or specific to Population #2):
1. Concomitant systemic sclerosis.
2. Active malignancy or history of malignancy within the last 5 years, except as follows:
a. In situ carcinoma of the cervix treated with apparent success with curative therapy
> 12 months prior to screening; OR
b. Cutaneous basal cell carcinoma following presumed curative therapy.
3. Individuals who are pregnant or lactating or planning to become pregnant during the study.
4. Individuals with known history of severe allergy or reaction to any component of the IP
formulation or to any other biologic therapy.
5. Individuals with any severe or life-threatening cardiovascular (including vasculitis and
uncontrolled hypertension), respiratory, endocrine, gastrointestinal, hematological,
neurological, psychiatric, or systemic disorder or any other condition that in the opinion of
the Investigator, would place the individual at unacceptable risk of complications, interfere
with evaluation of the IP, or confound the interpretation of participant safety or study results.
6. Individuals who, in the opinion of the Investigator, are unable or unwilling to comply with
protocol requirements (eg, active drug or alcohol abuse or for other reasons), including the
completion of the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI).
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or
human immunodeficiency virus (HIV) infection.
A positive test for hepatitis B at screening is defined as: (1) positive for hepatitis B surface
antigen (HBsAg) OR (2) positive for either hepatitis B core antibody (HBcAb) or hepatitis B
surface antibody (HBsAb) AND hepatitis B virus (HBV) DNA detected above the lower
limit of quantification (LLOQ) by reflex testing by the central laboratory at screening.
Individuals with a positive test for or a history of treatment for hepatitis C are excluded
except if they have a documented sustained viral response to antiviral drugs approved for the
treatment of hepatitis C, defined as an undetectable viral level of hepatitis C RNA at least
24 weeks following completion of therapy. Individuals with advanced fibrosis or cirrhosis
due to hepatitis C cannot be enrolled.
8. Individuals with a positive test for SARS-CoV-2 on the day of randomization. Only those
with symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to
exclusion criteria specific to Population #1 or specific to Population #2):
1. Concomitant systemic sclerosis.
2. Active malignancy or history of malignancy within the last 5 years, except as follows:
a. In situ carcinoma of the cervix treated with apparent success with curative therapy
> 12 months prior to screening; OR
b. Cutaneous basal cell carcinoma following presumed curative therapy.
3. Individuals who are pregnant or lactating or planning to become pregnant during the study.
4. Individuals with known history of severe allergy or reaction to any component of the IP
formulation or to any other biologic therapy.
5. Individuals with any severe or life-threatening cardiovascular (including vasculitis and
uncontrolled hypertension), respiratory, endocrine, gastrointestinal, hematological,
neurological, psychiatric, or systemic disorder or any other condition that in the opinion of
the Investigator, would place the individual at unacceptable risk of complications, interfere
with evaluation of the IP, or confound the interpretation of participant safety or study results.
6. Individuals who, in the opinion of the Investigator, are unable or unwilling to comply with
protocol requirements (eg, active drug or alcohol abuse or for other reasons), including the
completion of the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI).
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or
human immunodeficiency virus (HIV) infection.
A positive test for hepatitis B at screening is defined as: (1) positive for hepatitis B surface
antigen (HBsAg) OR (2) positive for either hepatitis B core antibody (HBcAb) or hepatitis B
surface antibody (HBsAb) AND hepatitis B virus (HBV) DNA detected above the lower
limit of quantification (LLOQ) by reflex testing by the central laboratory at screening.
Individuals with a positive test for or a history of treatment for hepatitis C are excluded
except if they have a documented sustained viral response to antiviral drugs approved for the
treatment of hepatitis C, defined as an undetectable viral level of hepatitis C RNA at least
24 weeks following completion of therapy. Individuals with advanced fibrosis or cirrhosis
due to hepatitis C cannot be enrolled.
8. Individuals with a positive test for SARS-CoV-2 on the day of randomization. Only those
with symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
262 participants
