Completed Enrollment

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

I4V-JE-JAJE -

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).

Trial Summary

Age Range
≥6 months
Conditions the trial is for
Aicardi Goutieres Syndrome (AGS)
What the trial is testing?
Baricitinib
Could I receive a Placebo?
No
Enrollment Goal
8
Trial Dates
Oct 27, 2020 - Apr 2025
How long will I be in the trial?
The study will last about 100 weeks and may include up to 25 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must be diagnosed with genetic diagnosis of NNS/CANDLE, SAVI, or AGS

  • Participants with NNS/CANDLE and SAVI must be 17.5 months of age, AGS must be 6 months of age

  • Participants must be 5kg in body weight

Participants Must Not:

  • Participants must not be pregnant or breastfeeding

  • Participant must not have active tuberculosis (TB)

  • Participant must not have cancer

  • Participants must not have any history of blood clot within 12 weeks before entering study

  • Participants must not have ever participated in any other clinical trials using baricitinib

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