Status:
TERMINATED
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
Lead Sponsor:
Eli Lilly and Company
Conditions:
Nakajo-Nishimura Syndrome
Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
Brief 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 dermatosi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04517253
Start Date
October 27 2020
End Date
November 28 2024
Last Update
July 10 2025
Active Locations (5)
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1
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-0813
2
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo, Japan, 113-8519
3
National Center For Child Health And Development
Setagaya-ku, Tokyo, Japan, 157-8535
4
Hiroshima University Hospital
Hiroshima, Japan, 734-8551