Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
265
Countries
5
Sites
24
Atopic Dermatitis Eczema
To describe long-term safety of lebrikizumab in pediatric participants with moderate-to-severe AD
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
- 15 Mar 2024 → ongoing
- Decision date (initial)
- 2023-08-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501478-21-00
- WHO UTN
- U1111-1289-0869
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To describe long-term safety of lebrikizumab in pediatric participants with moderate-to-severe AD
Conditions and MedDRA coding
Atopic Dermatitis Eczema
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-501476-25-00 | J2T-MC-KGBI/DRM06-AD13: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Have received treatment from study J2T-MC-KGBI
- Have completed study treatment from study J2T-MC-KGBI
Exclusion criteria 2
- Have developed a serious adverse event from participation in study J2T-MC-KGBI
- Have developed an adverse event from participation in study J2T-MC-KGBI
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Discontinued from Study Treatment due to Adverse Events (AEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10216907 · Product
- Active substance
- Lebrikizumab
- Substance synonyms
- RO5490255, LY3650150
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 50 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- 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
- 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 6
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Chantilly, United States | Laboratory analysis |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| WCG Clinical Inc. ORG-100040730
|
Plymouth Meeting, United States | Code 10 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
5 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 21 | 2 |
| France | Authorised, recruitment pending | 12 | 3 |
| Germany | Ongoing, recruiting | 16 | 5 |
| Poland | Ongoing, recruiting | 22 | 4 |
| Spain | Ongoing, recruiting | 16 | 10 |
| Rest of world
Canada, Argentina, United States, Australia, Brazil, Japan, Mexico, Taiwan
|
— | 178 | — |
Investigational sites
Fakultni Nemocnice Brno
NA, Cernopolni 9, Cerna Pole, Brno-Sever
Fakultni Nemocnice Bulovka
NA, Budinova 67/2, Liben, Prague
Hopitaux Drome Nord
Dermatology, 607 Avenue Genev De Gaulle Anthonioz, 26100, Romans-Sur-Isere
Centre Hospitalier Universitaire De Nantes
Dermatology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Toulouse
Dermatology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Thermalsole- Und Schwefelbad Bentheim GmbH
N/A, Am Bade 1, 48455, Bad Bentheim
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
N/A, Albert-Schweitzer-Campus 1, Sentrup, Münster
Rosenpark Research GmbH
N/A, Rheinstrasse 14, 64283, Darmstadt
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/u11, 31-559, Cracow
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
Evimed Sp. z o.o.
N/A, Ul. Jana Pawla Woronicza 16, 02-625, Warsaw
Complexo Hospitalario Universitario De Pontevedra
Dermatología, Calle Mourente S/n, 36164, Pontevedra
Hospital Infantil Universitario Nino Jesus
Dermatología, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital De Manises
Dermatología, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital Universitario Quironsalud Madrid
Dermatología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Gran Canaria Dr. Negrin
Dermatología, Barranco De La Ballena Sn, 35010, Las Palmas De Gran Canaria
Clinica Universidad De Navarra
Dermatología, Avenue Pio XII 36, 31008, Pamplona
Hospital Sant Joan de Déu
Dermatología, Paseo Sant Joan de Déu Nr. 2, 08950, Barcelona
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Dermatología, Calle De Serrano 143, 28006, Madrid
Hospital Universitario La Paz
Dermatología, Paseo Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Dermatología, Bloque D, Avenida De Cordoba S/n, Madrid
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 |
|---|---|---|---|---|---|
| Czechia | 2024-05-31 | 2024-06-17 | |||
| Germany | 2024-04-19 | 2024-04-23 | |||
| Poland | 2024-03-15 | 2024-03-18 | |||
| Spain | 2024-04-23 | 2024-04-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 96 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-501478-21-00_Redacted | g |
| Protocol (for publication) | D1_Protocol addendum 2022-501478-21-00_Redacted | 1.0 |
| Protocol (for publication) | D1_Protocol Synopsis 2 pages_ENG_2022-501478-21-00_Redacted | b |
| Protocol (for publication) | J2T-MC-KGBJ_Patient Documents Copyright Template | 1.0 |
| Protocol (for publication) | Justification to collect patients race or ethnicity data_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_List of planned sites_CZ | 1 |
| Recruitment arrangements (for publication) | K1_List of planned sites_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement Statement_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Spain_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitement and ICF procedure_CZ | 1 |
| Recruitment arrangements (for publication) | KGBJ_Informed consent and patient recruitment procedure | 1.0 |
| Subject information and informed consent form (for publication) | Blanket Statement | 1 |
| Subject information and informed consent form (for publication) | KGBJ_CZ_List of documents submitted for PartII | 1 |
| Subject information and informed consent form (for publication) | L1_SIS & ICF_Child 13 plus_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS & ICF_Child 13 plus_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS & ICF_Parent_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 17 years old_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 17 years old_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Older children_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form Younger children_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 years old_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 years old_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parental_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parental_Tracked changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_15-17_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Adult_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Caregiver_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Parent_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Addendum_Older kids_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent for older child 50 week extension period_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent for younger child 50 week extension period_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent form 15-17y_CZ_Highlighted_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_12-14_CZ_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_15-17_CZ_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CZ_Highlighted_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CZ_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Adult_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Parent_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for adults_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for adults_Spanish_TC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for parents_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF for parents_Spanish_TC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF por parents 50 week extension period_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF por patients 50 week extension period_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_CZ_Highlighted_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_CZ_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parent_CZ_Highlighted_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parent_CZ_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older child assent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF for adults | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF for parents | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF for parents_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger child assent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF for Parents_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Reimbursement ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L10_Other Subject information material_Greenphire Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L11_Other Subject information material_General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 2 |
| Subject information and informed consent form (for publication) | L12_Other Subject information material_Poland_-_EC_packet_w_Data_Privacy_as_applied_to_GP | 8 |
| Subject information and informed consent form (for publication) | L13_Contact Card for Study Participants | 1.0 |
| Subject information and informed consent form (for publication) | L14_CT-PFS-NSD-KGBJ | 1.0 |
| Subject information and informed consent form (for publication) | L15_Info Re-insurance Conditions for Patient_ver1_23May2023_Final_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Assent Addendum older children_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Assent Addendum younger children_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ICF Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Item | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Item | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Item | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Item_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT IFU_1 ml_PFS-NSD | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT IFU_2 ml_PFS-NSD | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CTIFU-1 mL-PFS-NSD | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CTIFU-2 mL-PFS-NSD | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direction for USE NSD | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted PL | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_SIS & ICF_Parent_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L3_SIS & ICF_Assent young child TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L3_SIS & ICF_Assent young child_Redacted | 2 |
| Subject information and informed consent form (for publication) | L4_LEBRIKIZUMAB PFS NSD_S_Paper_CZ | 1 |
| Subject information and informed consent form (for publication) | L4_SIS & ICF_Assent old child_Redacted | 3 |
| Subject information and informed consent form (for publication) | L4_SIS & ICF_Assent old child_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L5_Other Subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L7_Other Subject information material_ Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L8_Other Subject information material_Polish Greenphire ClinCard Msg Templates - ROW | 6 |
| Subject information and informed consent form (for publication) | L9_Other Subject information material_Greenphire ClinCard Travel Ref Guide for Subjects | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2022-501478-21-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2022-501478-21-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-501478-21-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GE_2022-501478-21-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-501478-21-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-501478-21-00_TC_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SP_2022-501478-21-00_Redacted | f |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-06 | Czechia | Acceptable 2023-07-31
|
2023-08-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-23 | Acceptable | 2023-09-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-29 | Czechia | Acceptable 2024-03-07
|
2024-03-07 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-25 | Acceptable 2024-03-07
|
2024-03-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-23 | Czechia | Acceptable 2024-06-19
|
2024-06-19 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-02 | Czechia | Acceptable 2024-12-09
|
2024-12-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-19 | Czechia | Acceptable 2025-04-10
|
2025-04-10 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-25 | Acceptable | 2025-06-03 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-04 | Czechia | Acceptable with conditions 2025-10-09
|
2025-10-09 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-24 | Czechia | Acceptable 2026-01-09
|
2026-01-09 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-05 | Czechia | Acceptable 2026-01-09
|
2026-05-05 |