Primary Sjogrens Syndrome
Conditions
Interventions
Product Name: RSLV-132
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of adm
Sponsors
Resolve Therapeutics, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria at Screening may be included in the study: 1. Meet 4 of the 6 criteria (must include histopathology or autoantibodies) of the 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren’s Syndrome 2. Elevated levels of anti Ro-52 or anti Ro-60 antibodies (within laboratory positive range); 3. Positive interferon signature (whole blood cell interferon signature metric >1); 4. Stable medications used to treat Sjogren’s syndrome for the 30 days prior to the Baseline visit; 5. Able to communicate and able to provide valid, written informed consent; 6. Ages 18 to 85 inclusive; 7. Minimum weight of 45 kg; 8. Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels > 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD], an intrauterine hormone releasing system [IUS] a male sexual partner who agrees to use a male condom with spermicide; a sterile or vasectomized sexual partner) for at least 2 months prior to dosing and until 90 days following the End of Study. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hCG] at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 90 days after the last dose. 9. Male participants, who are not sterile or vasectomized, must agree to use a male condom with spermicide from the first dose until 90 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 90 days after the last dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Any of the following will exclude potential subjects from the study: 1. Previously diagnosed with systemic lupus, systemic sclerosis, or inflammatory myopathy 2. Use of hydroxychloroquine within 30 days of Baseline; 3. Use of cyclophosphamide within 180 days of Baseline; 4. use of belimumab, abatacept, or TNF inhibitors wit Uin 90 days of Baseline; 5. Use of rituximab within 6 months of Baseline (documentation of B-cell counts within the normal range for the reference laboratory is required for subjects within 1 year of rituximab usage) 6. Use of oral corticosteroids equivalent to prednisone dose of >10 mg/day within 30 days of Baseline; 7. Past head and neck radiation; 8. Current untreated lymphoma at Baseline; 9. Known IgG4-related disease 10. Graft versus host disease 11. The presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug; 12. Positive test for hepatitis B, C, or HIV at Screening; 13. Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline; 14. Positive pregnancy test at Screening or Baseline; 15. Female subjects currently breast feeding at Baseline; 16. Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is to assess changes in blood cell gene expression or serum protein levels indicative of reduced inflammation in the active versus control groups. ; Secondary Objective: The secondary endpoints of the study are to assess the following parameters in the active versus control groups: •safety and tolerability; •Ro autoantibody levels; •total immunoglobulins; •complement levels (C3 & C4) •Erythrocyte Sedimentation Rate (ESR) •minor salivary gland histopathology •minor salivary gland interferon-stimulated gene expression; •disease activity (ESSDAI or PGA, Schirmer’s test, stimulated and unstimulated salivary flow); •patient-reported outcomes Additional exploratory evaluations may be considered as driven by the evolving understanding of the mechanism of action, technical feasibility, and any other clinical or immunological information that may become available during the course of the clinical study. Note: Additional exploratory endpoints will be specified in a separate laboratory manual and will be reported separately to the main safety, tolerability and efficacy endpoints of the study. ;Primary end point(s): Changes in blood cell gene expression or serum protein levels indicative of reduced inflammation in the active versus control groups comparing Baseline with Day 99 ;Timepoint(s) of evaluation of this end point: Day 99 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in the following parameters in the active versus control groups between baseline and day 99: • Safety and tolerability; • Ro autoantibody levels; • Total immunoglobulins; • Complement levels (C3 & C4) • Erythrocyte sedimentation rate (ESR) • Minor salivary gland histopathology • Minor salivary gland interferon-stimulated gene expression; • Disease activity (ESSDAI or PGA, Schirmer’s test, stimulated and unstimulated salivary flow); • Patient-reported outcomes as measured by the following: ESSPRI, FACIT, Profile of fatigue, EQ-5D-L, Fatigue VAS, and Neuropsychological analysis scales; ;Timepoint(s) of evaluation of this end point: Day 99 | — |
Countries
United Kingdom
Contacts
Public ContactChief Executive Officer
Resolve Therapeutics, LLC
Outcome results
None listed