Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
262
Countries
3
Sites
16
Atopic dermatitis
To compare the efficacy of LY3454738 versus placebo as measured by EASI-75 in the treatment of biologic-and-small-molecule—naïve participants with moderate-to-severe Atopic Dermatitis
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20], Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 25 Sep 2023 → 14 Mar 2025
- Decision date (initial)
- 2023-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502888-38-00
- WHO UTN
- U1111-1287-4840
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To compare the efficacy of LY3454738 versus placebo as measured by EASI-75 in the treatment of biologic-and-small-molecule—naïve participants with moderate-to-severe Atopic Dermatitis
Conditions and MedDRA coding
Atopic dermatitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Have active atopic dermatitis for over a year and include the following:
- EASI score ≥ 12 at first dosing visit
- vIGA-AD score ≥3 at first dosing visit
- Have ≥10% of BSA involvement (per EASI BSA) at first dosing visit
- Have little improvement with topical medicines.
Exclusion criteria 4
- Have any prior skin infections requiring treatment with topical corticosteroids.
- Have history of psoriasis
- Have other infections such as Hepatitis B or C
- Known allergy to study drug or any components to formulation or history of drug hypersensitivity reactions.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10162984 · Product
- Active substance
- LY3454738
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
SUB20079 · Substance
- Active substance
- Sodium Chloride Solution 0.9%
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
D02AC · Product
- Active substance
- Soft Paraffin and Fat Products
- Pharmaceutical form
- -
- Route of administration
- TOPICAL
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AC — SOFT PARAFFIN AND FAT PRODUCTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
D02AX · Product
- Active substance
- Other Emollients and Protectives
- Pharmaceutical form
- -
- Route of administration
- TOPICAL
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AX — OTHER EMOLLIENTS AND PROTECTIVES
- 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 11
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Ink Inc. ORG-100042433
|
Horsham, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Q2 Solutions - Innovation Labs ORL-000001075
|
Durham, United States | Other |
| OneStudy Team ORL-000001062
|
Boston, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Los Angeles, United States | Other |
| Tier 1 ORL-000001074
|
Covington, United States | Other |
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 29 | 5 |
| Italy | Not authorised | 26 | 4 |
| Poland | Ended | 39 | 7 |
| Rest of world
China, Korea, Republic of, Japan, Taiwan, Mexico, Canada, United States
|
— | 168 | — |
Investigational sites
Medmare Bt.
Medmare Bt., Jozsef Attila Utca 17, 8200, Veszprem
University Teaching Hospital Markusovszky
Borgyogyaszati Szakambulancia, Markusovszky Str. 5, 9700, Szombathely
Somogy Megyei Kaposi Mor Oktato Korhaz
Borgyogyaszati osztaly, Tallian Gyula Utca 20-32, 7400, Kaposvar
Allergo-Derm Bakos Kft.
Allergo-Derm Bakos Kft., Baross Utca 20, 5000, Szolnok
University Of Debrecen
Borgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Azienda Ospedaliero Universitaria Delle Marche
Dermatology, Via Conca 71, 60126, Ancona
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Dermatology, Piazzale Spedali Civili 1, 25123, Brescia
Humanitas Research Hospital
Dermatology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Senese
Dermatoloy, Viale Mario Bracci 2, 53100, Siena
Specderm Poznanska Sp. j.
SPECDERM, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Diamond Clinic Sp. z o.o.
Diamond Clinic, Ul. Stefana Rogozinskiego 6/u3, 31-559, Cracow
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Centrum Badań Klinicznych PI-House Sp. z o.o., Ul. Na Zaspe 3, 80-546, Gdansk
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
Dermoklinika, Centrum Medyczne, Al. Tadeusza Kosciuszki 93, 90-436, Lodz
Evimed Sp. z o.o.
Centrum Medyczne Evimed, Ul. Jana Pawla Woronicza 16, 02-625, Warsaw
Dermed Centrum Medyczne Sp. z o.o.
DERMED Centrum Medyczne Sp. z o.o., Ul. Piotrkowska 48, 90-265, Lodz
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 |
|---|---|---|---|---|---|
| Hungary | 2023-10-04 | 2023-10-05 | |||
| Poland | 2023-09-25 | 2023-09-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| ISA_J4E-MC-FR01 Final Summary of Results_2022-502888-38-00 SUM-101324
|
2025-10-08T18:24:23 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| ISA_J4E-MC-FR01_Lay person summary of results_2022-502888-38-00 | 2026-03-11T07:29:46 | Submitted | Laypersons Summary of Results |
| LY3454738 J4E-MC-FR01 Lay person summary of results_translated copies_Hungarian, Polish | 2026-04-08T10:23:41 | Submitted | Laypersons Summary of Results |
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ISA_J4E-MC-FR01_Lay person summary of results_2022-502888-38-00 | 1 |
| Laypersons summary of results (for publication) | LY3454738 FR01 Plain Language Summary Hungarian | 1 |
| Laypersons summary of results (for publication) | LY3454738 FR01 Plain Language Summary Polish | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recrutiment material List of planned sites | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Actigraphy Addendum_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_PL_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_PL_TC_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_non-Greenphire_PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_non-Greenphire_PL_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Skin punch biopsy Addendum_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Skin punch biopsy Addendum_PL_Tracked Chages_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard Msg Templates - ROW | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_EU | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_EC_packet_w_Data_Privacy_as_applied_to_GP | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Template EU Generic ClinCard | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant insert_Actigraphy_Poland_PL | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Instructions for Actigraphy_Poland_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Poster_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trial-Awareness-Brochure_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit-Card_PL | 1 |
| Summary of results (for publication) | ISA_J4E-MC-FR01 Final Summary of Results_2022-502888-38-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-18 | Italy | Acceptable 2023-08-07
|
2023-08-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-31 | Acceptable 2023-12-11
|
2023-12-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Acceptable 2024-07-10
|
2024-07-11 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-11 | Acceptable 2024-07-10
|
2024-12-11 |