Table 12.
DRUG | TRIAL (Reference) | Inclusion Criteria | Number of Subjects | Age (years) | Disease Duration (Years) | Mean ESSDAI | Primary Outcome | Results | Effects (Statistically Significant) | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Drg | Ctrl | Sicca Syndrome | Fibro-Like | Systemic | ||||||||
Daxdilimab
VIB7734 Anti-ILT7 |
NCT03817424 Phase I [370] |
Unspecified | ? | ? | ? | ? | SAEs at 169d AESIs at 169d |
June 2020 | na | na | na | na |
Filgotinib
Jak1 inhibitor |
NCT03100942 Phase II [342] |
AECG criteria SSa and/or SSb+ ESSDAI ≥ 4 |
38 | 37 | 52.2 ± 10.54 |
? | 10.2 ± 6.23 |
Protocol-Specified Response Criteria at 12w | not met | ESSPRI = | ESSPRI = | ESSDAI = |
Lanraplenib
(GS-9876) SIK inhibitor |
NCT03100942 Phase II [342] |
AECG criteria SSa and/or SSb+ ESSDAI ≥ 4 |
38 | 37 | 56.2 ± 9.72 |
? | 10.5 ± 4.89 |
Protocol-Specified Response Criteria at 12w | not met | ESSPRI = | ESSPRI = | ESSDAI = |
RSLV-132
RNase1-Fc fusion protein |
NCT03247686 Phase II [371] |
AECG criteria SSA+ Interferon signature |
22 | 8 | ? | ? | ? | Interferon gene expression at day99 | Not published | ESSPRI = | mPRO-F ⇧ DSST ⇩ FACIT-F = ESSPRI = |
ESSDAI = |
Low-dose
IL-2 T-reg induction |
NCT01988506 Phase II Transreg [372] |
pSS diagnosis | 84-132 | ? | ? | ? | T-reg percentage | Estimated Study Completion on February 2022 | na | na | na |