| Centro de Investigaciones Metabólicas (CINME) |
| Caba, Buenos Aires, Argentina, C1056ABJ |
| Contact 541150319914 |
| Principal Investigator: Maria Laura Galimberti |
| Centro Medico Dra. De Salvo |
| Capital Federal, Argentina, C1426ABP |
| Contact 541147815331 |
| Principal Investigator: Maria Florencia Fernandez |
| Fundacion CIDEA |
| Ciudad Autonoma Buenos Aires, Argentina, C1121ABE |
| Contact 541149615466 |
| Principal Investigator: Jorge Fernando Maspero |
| Instituto de Neumonología y Dermatología |
| Ciudad Autonoma Buenos Aires, Argentina, C1425BEA |
| Contact 541148233353 |
| Principal Investigator: Paula Carolina Luna |
| The Sydney Children's Hospitals Network |
| Westmead, New South Wales, Australia, 2145 |
| Contact 61298450179 |
| Principal Investigator: Li-Chuen Wong |
| Veracity Clinical Research Pty Ltd |
| Woolloongabba, Queensland, Australia, 4102 |
| Contact 61730391311 |
| Principal Investigator: Lynda Jane Spelman |
| Royal Childrens Hospital Melbourne |
| Parkville, Victoria, Australia, 3050 |
| Contact 61393455570 |
| Principal Investigator: John Su |
| Universitätsklinikum Graz |
| Graz, Steiermark, Austria, 8036 |
| Contact 4331638513055 |
| Principal Investigator: Barbara Binder |
| Medizinische Universität Wien |
| Wien, Vienna, Austria, 1090 |
| Contact 4314040032430 |
| Principal Investigator: Zsolt Szepfalusi |
| Sozialmedizinisches Zentrum Ost/Donauspital |
| Vienna, Wien, Austria, 1220 |
| Contact 431288024102 |
| Principal Investigator: Gregor Holzer |
| Hospital de Clinicas de Porto Alegre |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903 |
| Contact 555121018634 |
| Principal Investigator: Tania F Cestari |
| IDERJ - Instituto de Dermatologia e Estética do Brasil |
| Rio de Janeiro, RJ, Brazil, 22470-220 |
| Contact 552125372611 |
| Principal Investigator: Luna Azulay Abulafia |
| Fundação Faculdade de Medicina do ABC |
| Santo André, Sao Paulo, Brazil, 09060-650 |
| Contact 551149935459 |
| Principal Investigator: Roberta Fachini Jardim Criado |
| Instituto Brasil de Pesquisa Clínica - IBPCLIN |
| Rio de Janeiro, Brazil, 20241180 |
| Contact 552125277979 |
| Principal Investigator: Nidia Francisco Chicralla da Rocha |
| Hospital de Servidor Publico Estadual |
| São Paulo, Brazil, 04039-901 |
| Contact 551150840931 |
| Principal Investigator: Mario Cezar Pires |
| Fakultni Nemocnice v Motole |
| Praha 5, Hl. M. Praha, Czechia, 150 06 |
| Contact +420224435743 |
| Principal Investigator: Alena Machovcova |
| Fakultni nemocnice Bulovka |
| Praha 8, Hl. M. Praha, Czechia, 180 81 |
| Contact 420266082359 |
| Principal Investigator: Jana Třešňák Hercogová |
| Kozni oddeleni |
| Novy Jicin, Moravskoslezsky Kraj, Czechia, 741 01 |
| Contact 420556773533 |
| Principal Investigator: Marie Selerova |
| Fakultni nemocnice Hradec Kralove |
| Hradec Kralove, Czechia, 500 05 |
| Contact 420495836373 |
| Principal Investigator: Jirina Bartonova |
| Sanatorium profesora Arenbergera |
| Praha 1, Czechia, 110 00 |
| Contact 420224232468 |
| Principal Investigator: Petr Arenberger |
| Hôpital de Pontchaillou |
| Rennes, Cedex 9, France, 35033 |
| Contact 33299284349 |
| Principal Investigator: Catherine Droitcourt |
| Hopital Saint Eloi |
| Montpellier Cédex 05, Montpellier, France, 34295 |
| Contact +33467336906 |
| Principal Investigator: Aurélie DU-THANH |
| CHRU de Brest - Hôpital Morvan |
| Brest, France, 29200 |
| Contact 33298223315 |
| Principal Investigator: Claire Abasq |
| Hôpital Saint Vincent de Paul |
| Lille, France, 59020 |
| Contact +33320877576 |
| Principal Investigator: Audrey Lasek |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu |
| Nantes Cedex 1, France, 44093 |
| Contact 33240084086 |
| Principal Investigator: Sébastien Barbarot |
| CHU de Nice Hopital de L'Archet |
| Nice, France, 06202 |
| Contact 33492036119 |
| Principal Investigator: Thomas Hubiche |
| Hopitaux Drome-Nord |
| Romans-sur-Isere, France, 26102 |
| Contact 33475683780 |
| Principal Investigator: François Skowron |
| Hopital Larrey |
| Toulouse, France, 31059 |
| Contact 33567771876 |
| Principal Investigator: Juliette Mazereeuw |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt |
| Frankfurt am Main, Hessen, Germany, 60590 |
| Contact 4969630183115 |
| Principal Investigator: Andreas Pinter |
| Universitätsklinikum Münster |
| Münster, Nordrhein-Westfalen, Germany, 48149 |
| Contact 492518356558 |
| Principal Investigator: Nina Magnolo |
| Universitätsklinikum Carl Gustav Carus |
| Dresden, Sachsen, Germany, 01307 |
| Contact 493514580 |
| Principal Investigator: Susanne Abraham |
| Katholisches Kinderkrankenhaus Wilhelmstift |
| Hamburg, Germany, 22149 |
| Contact 494067377202 |
| Principal Investigator: Peter H. Höger |
| Oroshaza Varosi Onkormanyzat Korhaza |
| Oroshaza, Bekes, Hungary, 5900 |
| Contact 3668411166 |
| Principal Investigator: Piroska Szabo-Dosa |
| SZTE AOK Borgyogyaszati es Allergologiai Klinika |
| Szeged, Csongrad, Hungary, 6720 |
| Contact +36307890958 |
| Principal Investigator: Lajos Kemeny |
| Allergo-Derm Bakos Kft |
| Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000 |
| Contact 36209819476 |
| Principal Investigator: Noemi Bakos |
| Maulana Azad Medical College |
| New Delhi, Delhi, India, 110002 |
| Contact 09818244340 |
| Principal Investigator: Rashmi Sarkar |
| All India Institute of Medical Sciences |
| New Delhi, Delhi, India, 110029 |
| Contact 911126593217 |
| Principal Investigator: Neetu Bhari |
| Sir Ganga Ram Hospital |
| New Delhi, Delhi, India, 110060 |
| Contact 9911300050 |
| Principal Investigator: Rohit Batra |
| B. J. Medical College & Civil Hospital |
| Ahmedabad, Gujarat, India, 380016 |
| Contact 9898059289 |
| Principal Investigator: Bela Jaswantlal Shah |
| GMERS Medical College & Hospital |
| Vadodara, Gujarat, India, 390021 |
| Contact 9426570097 |
| Principal Investigator: Raksha Maganlal Patel |
| Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital |
| Nagpur, Maharashtra, India, 44001 |
| Contact 712-2643192 |
| Principal Investigator: Vinky Rughwani |
| Dr. D. Y. Patil Medical College & Hospital |
| Navi Mumbai, Maharashtra, India, 400706 |
| Contact 8850635503 |
| Principal Investigator: Sharmila Patil |
| Acharya Vinoba Bhave Rural Hospital |
| Wardha, Maharashtra, India, 442004 |
| Contact 7152-260310 |
| Principal Investigator: Amar Taksande |
| Lifepoint Multispecialty Hsptl |
| Wakad, Pune, India, 411057 |
| Contact 9960178611 |
| Principal Investigator: Sonal Shendkar |
| Post Graduate Institute of Medical Education & Research |
| Chandigarh, Punjab, India, 160012 |
| Contact 9815924777 |
| Principal Investigator: Sanjeev Handa |
| Aakash Healthcare Super Speciality Hospital |
| New Delhi, India, 110075 |
| Contact 9810042030 |
| Principal Investigator: Pooja Chopra |
| Ha'Emek Medical Center |
| Afula, Israel, 18101 |
| Contact 97246494006 |
| Principal Investigator: Michael Ziv |
| Soroka Medical Center |
| Beer Sheva, Israel, 8410101 |
| Contact 97286400653 |
| Principal Investigator: Amir Horev |
| Sheba Medical Center |
| Ramat Gan, Israel, 5265601 |
| Contact 97235302419 |
| Principal Investigator: Shoshana Greenberger |
| Tel Aviv Sourasky Medical Center |
| Tel Aviv, Israel, 6423906 |
| Contact 972527360093 |
| Principal Investigator: Yaacov Mashiah |
| Nagoya Medical Center |
| Nagoya, Aichi, Japan, 460-0001 |
| Contact 81120023812 |
| Principal Investigator: Masaki Futamura |
| Fukuyama City Hospital |
| Fukuyama-shi, Hiroshima, Japan, 721-8511 |
| Contact 81120023812 |
| Principal Investigator: Masanori Ikeda |
| Takeda Derm Skin Care Clin |
| Sapporo-city, Hokkaido, Japan, 004-0063 |
| Contact 81120023812 |
| Principal Investigator: Osamu Takeda |
| National Sagamihara Hospital |
| Sagamihara, Kanagawa, Japan, 252-0392 |
| Contact 81120023812 |
| Principal Investigator: Motohiro Ebisawa |
| Japan National Hospital Organization Mie Hospital |
| Tsu-shi, Mie, Japan, 514-0125 |
| Contact 81120023812 |
| Principal Investigator: Takao Fujisawa |
| Kume Clinic |
| Sakai City, Osaka, Japan, 593-8324 |
| Contact 81120023812 |
| Principal Investigator: Akihiro Kume |
| Senri-Chuo Hanafusa Dermatology Clinic |
| Toyonaka-shi, Osaka, Japan, 560-0085 |
| Contact 81120023812 |
| Principal Investigator: Takaaki Hanafusa |
| Dokkyo Medical University Hospital |
| Shimotsuga-Gun, Tochigi, Japan, 321 0293 |
| Contact 81120023812 |
| Principal Investigator: Shigemi Yoshihara |
| Tokyo Rosai Hospital |
| Ota-Ku, Tokyo, Japan, 143-0013 |
| Contact 81120023812 |
| Principal Investigator: Ken Hayashi |
| Shinjuku Minamiguchi Dermatology |
| Shinjuku-ku, Tokyo, Japan, 160-0023 |
| Contact 81120023812 |
| Principal Investigator: Toshitathu Nogita |
| Matsuda Tomoko Dermatological Clinic |
| Fukuoka, Japan, 819-0167 |
| Contact 81120023812 |
| Principal Investigator: Tomoko Matsuda |
| Consultorio Privado de la Dra. Villanueva |
| May 15, 2019
|
| May 16, 2019
|
| June 9, 2021
|
| May 24, 2019
|
| July 21, 2022 (Final data collection date for primary outcome measure)
|
|
|
|
Same as current
|
|
|
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) [ Time Frame: 16 Weeks ]
Percentage of participants achieving EASI75
- Percentage of Participants Achieving EASI90 [ Time Frame: 16 Weeks ]
Percentage of participants achieving EASI90
- Change from Baseline on EASI Score [ Time Frame: Baseline, 16 Weeks ]
Change from baseline on EASI Score
- Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) [ Time Frame: 16 Weeks ]
Percentage of participants achieving SCORAD75
- Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants ≥10 Years Old [ Time Frame: 16 Weeks ]
Percentage of participants achieving a 4-point improvement in Itch NRS for participants ≥10 years old
- Percentage of Participants Achieving EASI50 [ Time Frame: 16 Weeks ]
Percentage of participants achieving EASI50
- Percentage of Participants Achieving IGA of 0 [ Time Frame: 16 Weeks ]
Percentage of participants achieving IGA of 0
- Change from Baseline in SCORAD [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in SCORAD
- Percentage of Participants Achieving SCORAD90 [ Time Frame: 16 Weeks ]
Percentage of participants achieving SCORAD90
- Change from Baseline in Body Surface Area (BSA) Affected [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in BSA affected
- Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment [ Time Frame: 16 Weeks ]
Percentage of participants developing skin infections requiring antibiotic treatment
- Mean Number of Days without Use of Background Topical Corticosteroid (TCS) [ Time Frame: Baseline through 16 Weeks ]
Mean number of days without use of background TCS
- Mean Gram Quantity of TCS Use (Tube Weights) [ Time Frame: Baseline through 16 Weeks ]
Mean gram quantity of TCS use (tube weights)
- Change from Baseline in Itch NRS [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in itch NRS
- Change from Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants <10 years old [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in the PRISM for participants <10 years old
- Change from Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score [ Time Frame: Baseline, 16 Weeks ]
Change from baseline on the POEM total score
- Change from Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in PGI-S-AD score
- Change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pediatric Depression [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in the PROMIS-pediatric depression
- Change from Baseline in the PROMIS-Pediatric Anxiety [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in the PROMIS-pediatric anxiety
- Change from Baseline in the Children's/Infants's Dermatology Life Quality Index (CDLQI/IDQOL) [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in the CDLQI/IDQOL
- Change from Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score [ Time Frame: Baseline, 16 Weeks ]
Change from baseline on the WPAI-AD-CG score
- Change from Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) [ Time Frame: Baseline, 16 Weeks ]
Change from baseline on the EQ-5D-Y
- Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants ≥10 Years Old [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in the score of item 2 of the ADSS for participants ≥10 years old
- Change from Baseline in Skin Pain NRS for Participants ≥10 Years Old [ Time Frame: Baseline, 16 Weeks ]
Change from baseline in Skin Pain NRS for participants ≥10 years old
- Acceptability Assessment (PK Lead-In) [ Time Frame: 2 Weeks ]
Participants were evaluated for baricitinib acceptability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the ease of use of baricitinib: Very difficult (or hard), difficult (or hard), neither easy nor hard, easy, or very easy.
- Palatability Assessment (PK Lead-In) [ Time Frame: 2 Weeks ]
Participants were evaluated for baricitinib palatability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the taste and smell of baricitinib: Disliked very much, disliked, neither liked nor disliked, liked, or like very much.
- Change of Immunoglobulin G (IgG) Titers [ Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination ]
Change of IgG titers
- Height Growth Rate (in Centimeters/Year) [ Time Frame: 124 Weeks ]
Height growth rate (in centimeters/year)
- PK: Cmax of LY3009104 [ Time Frame: Baseline through 16 Weeks ]
PK: Cmax of LY3009104
- PK: AUC of LY3009104 [ Time Frame: Baseline through 16 Weeks ]
PK: AUC of LY3009104
|
|
Same as current
|
| Not Provided
|
| Not Provided
|
| |
| A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
|
| A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
|
| The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
|
| Not Provided
|
| Interventional
|
| Phase 3
|
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
|
| Atopic Dermatitis
|
|
|
- Experimental: Baricitinib Open Label High Dose
Baricitinib administered orally.
Intervention: Drug: Baricitinib
- Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Interventions:
- Drug: Baricitinib
- Drug: Topical corticosteroid
- Experimental: Baricitinib Mid Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Interventions:
- Drug: Baricitinib
- Drug: Topical corticosteroid
- Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Interventions:
- Drug: Baricitinib
- Drug: Topical corticosteroid
- Placebo Comparator: Placebo
Placebo administered orally. Matching placebo administered orally to maintain the blind.
Interventions:
- Drug: Placebo
- Drug: Topical corticosteroid
|
| Not Provided
|
| |
| Recruiting
|
| 465
|
|
Same as current
|
| January 15, 2027
|
| July 21, 2022 (Final data collection date for primary outcome measure)
|
|
Inclusion Criteria:
- At or above the 5th percentile of weight for age.
- Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
- Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- Agree to use emollients daily.
Exclusion Criteria:
|
| Sexes Eligible for Study: |
All |
|
| 2 Years to 17 Years (Child)
|
| No
|
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
1-317-615-4559 |
Clinicaltrials.gov@lilly.com |
|
|
| Argentina, Australia, Austria, Brazil, Czechia, France, Germany, Hungary, India, Israel, Japan, Mexico, Poland, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom
|
|
|
| |
| NCT03952559
|
16966 I4V-MC-JAIP ( Other Identifier: Eli Lilly and Company ) 2018-000349-38 ( EudraCT Number )
|
| Yes
|
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
| Product Manufactured in and Exported from the U.S.: |
Yes |
|
| Plan to Share IPD: |
Yes |
| 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. |
| Supporting Materials: |
Study Protocol |
| Supporting Materials: |
Statistical Analysis Plan (SAP) |
| Supporting Materials: |
Clinical Study Report (CSR) |
| 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. |
| Access Criteria: |
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
| URL: |
http://www.clinicalstudydatarequest.com |
|
| Eli Lilly and Company
|
| Eli Lilly and Company
|
| Incyte Corporation
|
| Study Director: |
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) |
Eli Lilly and Company |
|
| Eli Lilly and Company
|
| June 2021
|