A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS

JRCT ID: jRCT2031200152

Registered date:14/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: NNS/CANDLE, SAVI, and AGS
• Date of first enrollment: 27/10/2020
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Baricitinib administered orally either by tablet or suspension.

Outcome(s)

• Primary Outcome: Change from Baseline in Mean Daily Diary Scores

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT04517253