Recruiting

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

I4V-JE-JAJE - ClinicalTrials.gov - NCT04517253

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).
How long will I be in the trial?
The study will last about 100 weeks and may include up to 25 visits
Email
Recruiting

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

I4V-JE-JAJE - ClinicalTrials.gov - NCT04517253

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).
How long will I be in the trial?
The study will last about 100 weeks and may include up to 25 visits
Email

Key Requirements

Age (months):

6+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age (months)

6+

Sex

All

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

Trial Summary

Conditions the trial is for

Nakajo-Nishimura syndrome (NNS), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated Temperature Syndrome (CANDLE Syndrome), STING-Associated Vasculopathy with Onset in Infancy (SAVI), Aicardi Goutieres Syndrome (AGS)

What the trial is testing?

Baricitinib

Could I receive a Placebo?

no

Enrollment Goal

5

Trial Dates

October 2020 - January 2023

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age (months)

6+

Sex

All

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

Trial Summary

Conditions the trial is for

Nakajo-Nishimura syndrome (NNS), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated Temperature Syndrome (CANDLE Syndrome), STING-Associated Vasculopathy with Onset in Infancy (SAVI), Aicardi Goutieres Syndrome (AGS)

What the trial is testing?

Baricitinib

Could I receive a Placebo?

no

Enrollment Goal

5

Trial Dates

October 2020 - January 2023

Trial Phase

3

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?