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

Korábbi kezelés

• Concomitant systemic sclerosis.
• Individuals who have received live (attenuated) vaccine within the 4 weeks prior to randomization. Non-live vaccines are permitted during the study (see Inclusion Criterion 9for COVID-19 vaccines).
• 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).
• 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 COVID-19 within 10 days prior to randomization, should be tested. Individuals with COVID-19 or COVID-19 exposure can delay randomization up to 2 weeks with sponsor approval and randomize once recovered; otherwise, they will need to rescreen.
• Individuals with: a. A history of more than one episode of herpes zoster and/or opportunistic infections (see Section 10.3 [Appendix 3]) in the last 12 months, with the exception of noninvasive 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. b. Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening

Más betegség

• 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.
• Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
• 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.

Laborértékek

• Individuals who have a positive test 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 HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the 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

Egyéb

• Last administration of experimental biologic or oral agents < 6 months or 5 half-lives, whichever is longer, before screening.
• Individuals who are pregnant or lactating or planning to become pregnant during the study.

• 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.
• 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.
• 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.
• Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the definition of the standard central laboratory test).
• 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 ≥ 1mm/5 min.
• 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.
• 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) till the end of the study and refrain from sperm donation during this period and for a minimum of 15 days after the last dose of IP administration.
• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States [US], European Union [EU] Data Privacy Directive General Data Protection Regulation [GDPR] in the EU) obtained from the participant prior to performing any protocolrelated procedures, including screening evaluations.
• 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