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

Primary Purpose

Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy With Onset in Infancy

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Baricitinib
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nakajo-Nishimura Syndrome focused on measuring Nakajo-Nishimura Syndrome, CANDLE, SAVI, AGS

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hiroshima University Hospital
  • Nara Medical University Hospital
  • Tokyo Medical And Dental University Medical Hospital
  • National Center For Child Health And Development
  • Wakayama Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baricitinib

Arm Description

CANDLE: Participants with chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (CANDLE) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR). SAVI: Participants with STING-associated vasculopathy with onset during infancy (SAVI) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR). Aicardi-Goutières Syndrome (AGS): Participants with Aicardi-Goutières Syndrome (AGS) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR).

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Daily Diary Scores in Participants With SAVI
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For SAVI, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, fatigue, respiratory/breathing problems, and ulcers/ischemic lesions in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms,3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms].The mean daily score range was 0-4 with the higher score indicating a more severe symptom. Total score was not utilized.
Change From Baseline in Mean Daily Diary Scores in Participants With AGS
For AGS, participant or caregiver was instructed to rate each symptom (rating) (neurologic disability (0, 5, 7,10) crying (0, 1, 2, 3), length of uninterrupted sleep (0, 1, 2, 3), generalized seizure (0, 8), fever (0,1), excessive irritability (0, 1, 2, 3), skin findings(body) (0, 1, 2, 3), and skin findings (hands, feet, and ears) (0, 1, 2, 3) with a higher score for each symptom indicating a more severe symptom. The mean daily diary score was the average of all symptom scores and the range was 0 - 4.25 with the higher score indicating a more severe symptom. Total score was not utilized.
Change From Baseline in Mean Daily Diary Scores in Participants With CANDLE
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.

Secondary Outcome Measures

Change From Baseline in Mean Daily Diary Scores
Change from Baseline in Mean Daily Diary Scores
Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With SAVI and AGS
Decrease was defined as total steroid dose at the visit <0.15 mg/kg/day (prednisone-equivalent) or >=50% decrease from baseline.
Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With CANDLE
Decrease was defined as total steroid dose at the visit <0.15 mg/kg/day (prednisone-equivalent) or >=50% decrease from baseline.
Number of Participants With Decrease in Daily Dose of Corticosteroids
Number of participants with decrease in Daily Dose of Corticosteroids
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With SAVI
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For SAVI, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, fatigue, respiratory/breathing problems, and ulcers/ischemic lesions in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With AGS
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For AGS, participant or caregiver was instructed to rate each symptom (rating) (neurologic disability (0, 5, 7,10) crying (0, 1, 2, 3), length of uninterrupted sleep (0, 1, 2, 3), generalized seizure (0, 8), fever (0,1), excessive irritability (0, 1, 2, 3), skin findings(body) (0, 1, 2, 3), and skin findings (hands, feet, and ears) (0, 1, 2, 3) with a higher score for each symptom indicating a more severe symptom.
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With CANDLE
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Change From Baseline in Patient's Symptom Specific Daily Diary Scores
Change from Baseline in Patient's Symptom Specific Daily Diary Scores
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With SAVI and AGS
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle VAS ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity".
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With CANDLE
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity".
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to That in Pre-treatment Period in Participants With CANDLE
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to that in Pre-treatment period in Participants With CANDLE
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5
Change in Growth Velocity
Change in Growth Velocity
Change From Pre-treatment Period in Mean Daily Diary Scores For Participants With CANDLE
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Change From Pre-treatment Period in Mean Daily Diary Scores
Change from Pre-treatment period in Mean Daily Diary Scores
Change From Pre-treatment Period in the Physician's Global Assessment of Disease Activity Scores For Participants With CANDLE
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity" (Filocamo et al. 2010).
Change From Pre-treatment Period in the Physician's Global Assessment of Disease Activity Scores
Change from Pre-treatment period in the Physician's Global Assessment of Disease Activity Scores

Full Information

First Posted
August 17, 2020
Last Updated
November 28, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04517253
Brief Title
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
Official Title
A Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and Aicardi-Goutières Syndrome (AGS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy With Onset in Infancy, Aicardi Goutieres Syndrome
Keywords
Nakajo-Nishimura Syndrome, CANDLE, SAVI, AGS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
CANDLE: Participants with chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (CANDLE) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR). SAVI: Participants with STING-associated vasculopathy with onset during infancy (SAVI) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR). Aicardi-Goutières Syndrome (AGS): Participants with Aicardi-Goutières Syndrome (AGS) received an optimized dosage of baricitinib that was determined throughout the dose-adjustment period administered as tablets or oral suspension based on participants weight and estimated glomerular filtration rate (eGFR).
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Daily Diary Scores in Participants With SAVI
Description
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For SAVI, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, fatigue, respiratory/breathing problems, and ulcers/ischemic lesions in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms,3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms].The mean daily score range was 0-4 with the higher score indicating a more severe symptom. Total score was not utilized.
Time Frame
Baseline, up to 32 weeks
Title
Change From Baseline in Mean Daily Diary Scores in Participants With AGS
Description
For AGS, participant or caregiver was instructed to rate each symptom (rating) (neurologic disability (0, 5, 7,10) crying (0, 1, 2, 3), length of uninterrupted sleep (0, 1, 2, 3), generalized seizure (0, 8), fever (0,1), excessive irritability (0, 1, 2, 3), skin findings(body) (0, 1, 2, 3), and skin findings (hands, feet, and ears) (0, 1, 2, 3) with a higher score for each symptom indicating a more severe symptom. The mean daily diary score was the average of all symptom scores and the range was 0 - 4.25 with the higher score indicating a more severe symptom. Total score was not utilized.
Time Frame
Baseline, up to 32 weeks
Title
Change From Baseline in Mean Daily Diary Scores in Participants With CANDLE
Description
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Time Frame
Baseline, up to 20 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Daily Diary Scores
Description
Change from Baseline in Mean Daily Diary Scores
Time Frame
Baseline, up to 172 weeks
Title
Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With SAVI and AGS
Description
Decrease was defined as total steroid dose at the visit <0.15 mg/kg/day (prednisone-equivalent) or >=50% decrease from baseline.
Time Frame
Week 32
Title
Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With CANDLE
Description
Decrease was defined as total steroid dose at the visit <0.15 mg/kg/day (prednisone-equivalent) or >=50% decrease from baseline.
Time Frame
Week 20
Title
Number of Participants With Decrease in Daily Dose of Corticosteroids
Description
Number of participants with decrease in Daily Dose of Corticosteroids
Time Frame
Baseline, up to 172 weeks
Title
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With SAVI
Description
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For SAVI, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, fatigue, respiratory/breathing problems, and ulcers/ischemic lesions in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Time Frame
Baseline, up to 32 weeks
Title
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With AGS
Description
Diaries were specific to individual indications or conditions (i.e. NNS/CANDLE, SAVI, or AGS). For AGS, participant or caregiver was instructed to rate each symptom (rating) (neurologic disability (0, 5, 7,10) crying (0, 1, 2, 3), length of uninterrupted sleep (0, 1, 2, 3), generalized seizure (0, 8), fever (0,1), excessive irritability (0, 1, 2, 3), skin findings(body) (0, 1, 2, 3), and skin findings (hands, feet, and ears) (0, 1, 2, 3) with a higher score for each symptom indicating a more severe symptom.
Time Frame
Baseline, up to 32 weeks
Title
Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With CANDLE
Description
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Time Frame
Baseline, up to 20 weeks
Title
Change From Baseline in Patient's Symptom Specific Daily Diary Scores
Description
Change from Baseline in Patient's Symptom Specific Daily Diary Scores
Time Frame
Baseline, up to 172 weeks
Title
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With SAVI and AGS
Description
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle VAS ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity".
Time Frame
Baseline, up to 32 weeks
Title
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With CANDLE
Description
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity".
Time Frame
Baseline, up to 20 weeks
Title
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores
Description
Change From Baseline in the Physician's Global Assessment of Disease Activity Scores
Time Frame
Baseline, up to 172 weeks
Title
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to That in Pre-treatment Period in Participants With CANDLE
Description
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to that in Pre-treatment period in Participants With CANDLE
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 20 weeks
Title
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5
Description
Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 172 weeks
Title
Change in Growth Velocity
Description
Change in Growth Velocity
Time Frame
Baseline, up to 172 weeks
Title
Change From Pre-treatment Period in Mean Daily Diary Scores For Participants With CANDLE
Description
Diaries were specific to individual indications or conditions (ie, NNS/CANDLE,SAVI, or AGS). For NNS/CANDLE, participant or caregiver was instructed to rate each symptom (fever, rash, musculoskeletal pain, headache and fatigue in the diary on a scale from 0 to 4 (where a score of 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = more severe symptoms, and 4 = severe symptoms [equivalent to "worst" symptoms]. The mean daily score range was 0-4 with the higher score indicating a more severe symptom.
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 20 weeks
Title
Change From Pre-treatment Period in Mean Daily Diary Scores
Description
Change from Pre-treatment period in Mean Daily Diary Scores
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 172 weeks
Title
Change From Pre-treatment Period in the Physician's Global Assessment of Disease Activity Scores For Participants With CANDLE
Description
The Physician's Global Assessment of Disease Activity is used to assess the patient's current disease activity, as it relates to their signs and symptoms. The instrument uses a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10 (using 0.5 increments) where 0 = "no activity" and 10 = "maximum activity" (Filocamo et al. 2010).
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 20 weeks
Title
Change From Pre-treatment Period in the Physician's Global Assessment of Disease Activity Scores
Description
Change from Pre-treatment period in the Physician's Global Assessment of Disease Activity Scores
Time Frame
Pre-treatment period (average of 12-week pre-treatment data), up to 172 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima-ken
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Tokyo Medical And Dental University Medical Hospital
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Center For Child Health And Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4deb45sM6OlbQ6MBzCAx6H
Description
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS

Learn more about this trial

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

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