A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
- Conditions
- S/CANDLE, SAVI, and AGS
- Registration Number
- JPRN-jRCT2031200152
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Mean Daily Diary Scores
- Secondary Outcome Measures
Name Time Method