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

• Status: Active, not recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and Aicardi-Goutières Syndrome (AGS).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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 ≥17.5 months of age

• AGS patients who are ≥6 months of age

• Are ≥ 5kg in body weight

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.