Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
765
Countries
5
Sites
43
Alopecia areata (AA)
To test the hypothesis that the high dose or the low dose of baricitinib is superior to placebo in the treatment of pediatric participants with AA
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
- 1 Sep 2023 → ongoing
- Decision date (initial)
- 2023-08-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502700-78-00
- WHO UTN
- U1111-1288-2979
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic
To test the hypothesis that the high dose or the low dose of baricitinib is superior to placebo in the treatment of pediatric participants with AA
Conditions and MedDRA coding
Alopecia areata (AA)
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-001220-PIP08-20
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have severe areata alopecia (AA) for at least 1 year
- Current AA episode of at least 6 months’ duration with hair loss encompassing ≥50% of the scalp
- Current episode of severe to very severe alopecia areata of less than 8 years. - Participants who have severe AA for ≥ 8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years
Exclusion criteria 3
- Participants must not have primarily “diffuse” type of alopecia areata
- Participants must not be currently experiencing other forms of alopecia or any other health problem that would make it difficult to see how the study drug is working on alopecia areata
- Participants must not have topical applied to scalp within 4 weeks of randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of participants achieving an absolute Severity of Alopecia Tool (SALT) ≤ 20
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
- 3808 mg milligram(s)
- Max treatment duration
- 136 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 as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
PRD10309000 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3808 mg milligram(s)
- Max treatment duration
- 136 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- 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
- 3808 mg milligram(s)
- Max treatment duration
- 136 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 as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 3808 mg milligram(s)
- Max treatment duration
- 136 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- Orphan designation
- No
Placebo 1
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- Lilly Technology Center Building 324
- City
- Indianapolis
- Postcode
- 46221
- 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 10
| Organisation | City, country | Duties |
|---|---|---|
| Cyberchrome Inc. ORG-100042286
|
Branford, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 12, Other, Code 2, Laboratory analysis, Code 5, Data management |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Covance Bioanalytical Services LLC ORG-100037229
|
Indianapolis, United States | Laboratory analysis |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | E-data capture |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other, Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management, E-data capture |
| AG Mednet Inc. ORG-100039869
|
Boston, United States | Other |
Locations
5 EU/EEA countries · 43 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 28 | 5 |
| Germany | Ongoing, recruitment ended | 55 | 10 |
| Hungary | Ongoing, recruitment ended | 28 | 2 |
| Poland | Ongoing, recruitment ended | 250 | 18 |
| Spain | Ongoing, recruitment ended | 53 | 8 |
| Rest of world
Japan, Taiwan, United States, Argentina, Australia, Korea, Republic of, Mexico, Canada
|
— | 351 | — |
Investigational sites
Centre Hospitalier Universitaire De Nice
Dermatology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Regional Universitaire De Tours
Pedriatric Medicine, 49 Boulevard Beranger, 37000, Tours
Centre D'etude De La Peau Et Du Cheveu
Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Marseille
Dermatology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nantes
Dermatology, 1 Place Alexis Ricordeau, 44000, Nantes
Universitaetsklinikum Schleswig-Holstein
Institut für Entzündungsmedizin, Ratzeburger Allee 160, 23538, Lübeck
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Frankfurt AöR
Klinik für Dermatologie, Venerologie und Allergologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH
Dermatologie, Liliencronstrasse 130, Rahlstedt, Hamburg
BAG Dres. med. Quist PartG
N/A, Haifa-Allee 20, 55128, Mainz
Thermalsole und Schwefelbad Bentheim GmbH
Fachabteilung Dermatologie, Am Bade 1, 48455, Bad Bentheim
Universitaetsklinikum Muenster AöR
Klinik für Hautkrankheiten, Von-Esmarch-Strasse 58, Sentrup, Muenster
Universitaetsklinikum Halle (Saale) AöR
Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
University Medical Center Hamburg-Eppendorf
Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen, Martinistrasse 52, Eppendorf, Hamburg
Charite Universitaetsmedizin Berlin KöR
Klinik für Dermatologie, Venerologie und Allergologie, Chariteplatz 1, Mitte, Berlin
University Of Pecs
PTE KK Bőr-, Nemikórtani és Onkodermatológiai Klinika, Akac Utca 1, 7632, Pecs
University Of Debrecen
Bőrgyógyászati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Care Clinic Sp. z o.o.
N/A, Ul. Ligocka 103, 40-568, Katowice
Provita 001
N/A, Ul. Baboszewska 1/2U4, 02-647, Warsaw
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SC
N/A, ulica Zbozowa 2/25, 30-002, Krakow
Evimed Sp. z o.o.
N/A, Ul. Jana Pawla Woronicza 16, 02-625, Warsaw
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
N/A, Ul. Jana Kasprowicza 27/2, 01-817, Warszawa
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Dermatologii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Klinika Ambroziak Sp. z o.o.
N/A, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
Dermedic Jacek Zdybski
N/A, Sienkiewicza 65/14/II, 27-400, Ostrowiec Swietokrzyski
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
N/A, Al. Piastow 65/U5, 70-332, Szczecin
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
N/A, Al. Tadeusza Kosciuszki 93, 90-436, Lodz
Royalderm Agnieszka Nawrocka
N/A, ulica Krzysztofa Kieslowskiego 3B/3, 02-962, Warszawa
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
NZOZ Specjalistyczny Osrodek Dermatologiczny ”Dermal”
N/A, Ul. Nowy Swiat 17/5, 15-453, Bialystok
Gabinet Dermatologiczny Beata Krecisz
N/A, Ul. Generala Andersa 5/U, 25-217, Kielce
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
N/A, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Provita Sp. z o.o.
N/A, Ul. Fabryczna 13d, 40-611, Katowice
Hospital Universitario Infanta Leonor
Dermatology department, Avenida Gran Via Del Este 80, 28031, Madrid
Icr Medical S.L.
Dermatology department, Calle De Serrano 143, 28006, Madrid
Hospital Universitario Basurto
Dermatology department, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitari Germans Trias I Pujol
Dermatology department, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario 12 De Octubre
Dermatology department, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital General Universitario De Valencia
Dermatology department, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital General Universitario Dr. Balmis
Dermatology department, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Del Mar
Dermatology department, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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 |
|---|---|---|---|---|---|
| France | 2023-09-06 | 2023-09-18 | 2025-08-29 | ||
| Germany | 2023-10-30 | 2023-12-13 | 2025-09-26 | ||
| Hungary | 2023-09-06 | 2023-10-18 | 2025-08-28 | ||
| Poland | 2023-09-01 | 2023-09-14 | 2025-11-26 | ||
| Spain | 2023-09-05 | 2023-09-25 | 2025-08-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 71 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502700-78-00_FP | f |
| Protocol (for publication) | D1_Protocol_2022-502700-78-00_Ve_TC_NFP | e |
| Protocol (for publication) | D4_Patient facing document Pediatric Peer Relationships_HU_NFP | 2.0 |
| Protocol (for publication) | D4_Patient facing document PROMIS Depressive Symptoms_HU_NFP | 2.0 |
| Protocol (for publication) | D4_Patient facing document PROMIS Peer Relationships_HU_NFP | 2.0 |
| Protocol (for publication) | D4_Patient facing document statement_FP | N/A |
| Recruitment arrangements (for publication) | K1_NTF Recruitment Materials | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 1 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 2-0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Template | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FP | 1-0 |
| Recruitment arrangements (for publication) | K2_BARICITINIB-SYRINGE-CT-IFU-JAIO_FP | N/A |
| Recruitment arrangements (for publication) | K2_IFU_FP | N/A |
| Recruitment arrangements (for publication) | K2_NTF Recruitment Materials | 1 |
| Recruitment arrangements (for publication) | K2_NTF Recruitment Materials | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IFU_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_NTF 2_re Recruitment Procedures_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment materials_IFU_FP | N/A |
| Recruitment arrangements (for publication) | K2_Rectruitment Material_Placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K2_Rectruitment Material_Placeholder_FP | N/A |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_Opt Photo ICF Addendum_Parent_Participant-Assent 12-17_FP | 1 |
| Subject information and informed consent form (for publication) | L1_Optional Photography Consent Assent 13-18_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Adult | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 12-17 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 6-11 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 6-11 yrs_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent_Older Children (12-17) | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent_Younger Children (6-11)_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Child 11-14y | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Child 15-17y | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Child less 10y | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Reimbursement and Reminder_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire Adult | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Greenphire Parents | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Information form 12-17 yrs_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Opt Photography Add Adult-Parents_FP | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Opt Photography Add Assent (12-17)_FP | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parents | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Participant with Pregnant Partner_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Patient_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner Participant | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Reimbursement_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Younger Adult_Legal Rep_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_Assent 13-17 | 1 |
| Subject information and informed consent form (for publication) | L1_SISICF_Assent 6-12 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_Main ICF Adults-Parents | 5.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_PP | 1 |
| Subject information and informed consent form (for publication) | L1_SISICF_Reimbursement | 1 |
| Subject information and informed consent form (for publication) | L2_Pt. Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS-ICF_Pregnant Partner | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC baricitinib_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2022-502700-78-00_FP | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2022-502700-78-00_FP | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2022-502700-78-00_FP | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2022-502700-78-00_FP | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis HU 2022-502700-78-00_FP | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2022-502700-78-00_FP | f |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-02 | France | Acceptable with conditions 2023-08-25
|
2023-08-28 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-09-22 | Acceptable with conditions 2023-08-25
|
2023-10-23 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-23 | Acceptable with conditions 2023-08-25
|
2023-11-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-10 | France | Acceptable 2024-07-15
|
2024-07-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-14 | France | Acceptable 2025-05-06
|
2025-05-06 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-18 | France | Acceptable 2025-05-06
|
2025-06-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-15 | France | Acceptable 2025-05-06
|
2025-07-15 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-14 | France | Acceptable 2025-05-06
|
2025-08-14 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-02 | France | Acceptable | 2025-09-12 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-02 | Acceptable | 2025-09-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-27 | Acceptable | 2026-03-31 |