NNS/CANDLE, SAVI, and AGS
Conditions
Interventions
Baricitinib administered orally either by tablet or suspension.
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have systemic signs and symptoms of inflammation as manifested NNS/CANDLE, SAVI, AGS - Have been diagnosed with genetic diagnosis - Men must agree to use a reliable method of birth control during the study - Women not of child-bearing potential or nonbreastfeeding - Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment - NNS/CANDLE and SAVI patients who are equal to or more than 17.5 months of age - AGS patients who are equal to or more than 6 months of age - Are equal to or more than 5kg in body weight
Exclusion criteria
Exclusion criteria: - Have received immunosuppressive biologic agent/monoclonal antibody/oral JAK inhibitor/OAT3 inhibitor and cannot discontinue prior to investigational product initiation. Note: A washout period is required to each drug. - Have diagnosis of current active tuberculosis (TB) or, latent TB who did not receive appropriate treatment. - Have had a serious infection within 12 weeks prior to screening. - Have a history of lymphoproliferative disease - Have any history of venous thromboembolic event (VTE) (deep vein thrombosis [DVT]/pulmonary embolism [PE]) prior to screening. - Have had any major surgery within 8 weeks prior to screening. - Have previously been enrolled in any other study investigating baricitinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Daily Diary Scores | — |
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed