Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
556
Countries
7
Sites
29
Atopic Dermatitis
To see if the study drug called Baricitinib works and is safe in children and teenage participants with atopic dermatitis.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 24 May 2019 → 22 May 2026
- Decision date (initial)
- 2024-04-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503898-38-00
- EudraCT number
- 2018-000349-38
- WHO UTN
- U1111-1301-2415
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To see if the study drug called Baricitinib works and is safe in children and teenage participants with atopic dermatitis.
Conditions and MedDRA coding
Atopic Dermatitis
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-001220-PIP03-16
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 15
- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
- Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
- Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
- Have been treated with the following therapies: Monoclonal antibody for less than 5 half-lives prior to beginning study treatment. Received prior treatment with any oral Janus kinase (JAK) inhibitor. Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug or are anticipated to require parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned initiation of study drug.
- Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height.
- Have had major surgery within the past eight weeks or are planning major surgery during the study.
- Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of VTE or are considered at high risk of VTE as deemed by the investigator.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis.
- Have specific laboratory abnormalities.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- 1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement
- 2. Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104.
- 3. Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
- 4. Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7504 mg milligram(s)
- Max treatment duration
- 268 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with commercial drug substance (baricitinib) and unit formula same as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All appropriate for clinical trial use.
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7504 mg milligram(s)
- Max treatment duration
- 268 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- Orphan designation
- No
SUB180983 · Substance
- Active substance
- Baricitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7504 mg milligram(s)
- Max treatment duration
- 268 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with commercial drug substance (baricitinib) and unit formula same as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All appropriate for clinical trial use.
PRD10309000 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 7504 mg milligram(s)
- Max treatment duration
- 268 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 4
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match 2mg/ml oral suspension
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 4
SUB04936MIG · Substance
- Active substance
- Triamcinolone Acetonide
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD1837637 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- D07AA02 — HYDROCORTISONE
- Marketing authorisation
- 57574.02.00
- MA holder
- DERMAPHARM AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Valencia, United States | Laboratory analysis |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 10 |
| Covance Bioanalytical Services LLC ORG-100037229
|
Indianapolis, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Data management |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 10 | 3 |
| Czechia | Ended | 22 | 4 |
| France | Ended | 18 | 7 |
| Germany | Ended | 6 | 4 |
| Hungary | Ended | 13 | 2 |
| Poland | Ended | 89 | 3 |
| Spain | Ended | 36 | 6 |
| Rest of world
Israel, Brazil, Japan, United Kingdom, Australia, Taiwan, Mexico, Argentina, India, Russian Federation, Switzerland
|
— | 362 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Pediatrics and Adolescent Medicine, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinik Donaustadt
Dermatology, Langobardenstrasse 122, Donaustadt, Vienna
Medizinische Universität Graz
Dermatology and Venereology, Auenbruggerplatz 8, 8036, Graz
Fakultni Nemocnice Bulovka
Infectious diseases department, Budinova 67/2, Liben, Prague
Fakultni Nemocnice Hradec Kralove
Klinika nemoci koznich a pohlavnich, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice V Motole
Dermatovenerologicke oddeleni, V Uvalu 84/1, Motol, Prague
Nemocnice AGEL Novy Jicin a.s.
Oddeleni radioterapie a onkologie, Purkynova 2138/16, 741 01, Novy Jicin
Centre Hospitalier Universitaire De Toulouse
Service de dermatologie, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Regional Et Universitaire De Brest
Service de dermatologie, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
Centre Hospitalier Universitaire De Nice
Service de dermatologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Montpellier
Departement de dermatologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopitaux Drome Nord
Service de dermatologie, 607 Avenue Genev De Gaulle Anthonioz, 26100, Romans-Sur-Isere
Groupement Des Hopitaux De L'Institut Catholique De Lille
Service de dermatologie, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier Universitaire De Nantes
Service de dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH
N/A, Liliencronstrasse 130, Rahlstedt, Hamburg
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaet Muenster
N/A, Von-Esmarch-Strasse 58, Sentrup, Muenster
University Of Szeged
Bőrgyógyászati és Allergológiai Klinika, Koranyi Fasor 6, 6720, Szeged
Allergo-Derm Bakos Kft.
N/A, Baross Utca 20, 5000, Szolnok
Dermed Centrum Medyczne Sp. z o.o.
N/A, Ul. Piotrkowska 48, 90-265, Lodz
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Hospital Universitario Puerta De Hierro De Majadahonda
Dermatology, Calle De Manuel De Falla 1, 28222, Majadahonda
Sant Joan De Deu Barcelona Hospital
Dermatology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Infantil Universitario Nino Jesus
Dermatology, Avenida Menendez Pelayo 65, 28009, Madrid
Clinica Universidad De Navarra
Dermatology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario La Paz
Dermatology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Quironsalud Madrid
Dermatology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2020-06-16 | 2025-03-18 | 2020-07-02 | 2022-01-05 | |
| Czechia | 2020-02-26 | 2026-02-04 | 2020-02-27 | 2022-01-05 | |
| France | 2020-03-02 | 2026-05-12 | 2020-10-09 | 2022-01-05 | |
| Germany | 2020-09-30 | 2025-09-29 | 2021-03-15 | 2022-01-05 | |
| Hungary | 2019-11-21 | 2025-11-10 | 2020-03-04 | 2022-01-05 | |
| Poland | 2020-06-03 | 2026-04-28 | 2020-06-22 | 2022-01-05 | |
| Spain | 2019-05-24 | 2026-03-24 | 2019-05-24 | 2022-01-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 34 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PGI-S-AD_WS_Paper_German-DE_ | 1 |
| Protocol (for publication) | D1_Poem-for-self-completion-or-proxy-completion_WS_Paper_German-DE | 1 |
| Protocol (for publication) | D1_PRISM_WS_Paper_German-DE | 1 |
| Protocol (for publication) | D1_Protocol_2023-503898-38-00_redacted | d |
| Protocol (for publication) | JAIP Patient Documents Copyright Template_v1 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K3_Justification on the collection of date of birth_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K3_Justification on the collection of race and ethnicity_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Principal_Adultos_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda telemedicina_Adultos_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adenda telemedicina_Padres_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PK_ Adultos_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PK_Asentimiento ninos de 12-18 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PK_Asentimiento ninos menores de 12 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PK_Padres_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Asentimiento ninos de 12-18 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Asentimiento ninos menores de 12 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_Padres_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient cards | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis France | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503898-38-00_AT | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503898-38-00_AT_TC | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503898-38-00_CZ_tracked | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503898-38-00_ENG | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503898-38-00_ENG_TC | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503898-38-00_Hungary | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503898-38-00_Hungary_TC | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503898-38-00_PL | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503898-38-00_PL_TC | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-503898-38-00 | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-503898-38-00_TC | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_France TC | d |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-06 | Czechia | Acceptable 2024-04-18
|
2024-04-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-16 | Acceptable | 2024-07-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-25 | Czechia | Acceptable 2025-01-10
|
2025-01-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-16 | Czechia | 2025-01-16 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-13 | Czechia | 2025-08-13 |