Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
332
Countries
6
Sites
29
Rheumatoid Arthritis
Phase 2a: To evaluate the efficacy of LY3871801 compared to placebo as measured by changes in DAS28-hsCRP Phase 2b: To evaluate the efficacy of LY3871801 compared to placebo in achieving ACR50
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 4 Sep 2023 → 23 Apr 2026
- Decision date (initial)
- 2023-08-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502994-40-00
- WHO UTN
- U1111-1287-0634
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Dose response, Safety, Pharmacodynamic, Pharmacogenetic, Pharmacogenomic, Efficacy
Phase 2a: To evaluate the efficacy of LY3871801 compared to placebo as measured by changes in DAS28-hsCRP
Phase 2b: To evaluate the efficacy of LY3871801 compared to placebo in achieving ACR50
Conditions and MedDRA coding
Rheumatoid Arthritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Have a diagnosis of adult onset rheumatoid arthritis for at least 3 months
Exclusion criteria 4
- Had cancer within the last 5 years, except for some types of skin cancer or cervical cancer
- Had certain types of infections within the last 3 months
- Have HIV
- Have current hepatitis virus B or C infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2a: Change from Baseline in Disease Activity Score – high-sensitivity C-reactive protein (DAS28-hsCRP)
- Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10250625 · Product
- Active substance
- LY3871801
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 24 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
- Max treatment duration
- 24 Week(s)
- 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 8
| Organisation | City, country | Duties |
|---|---|---|
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other |
| Spire Sciences, Inc. ORL-000001063
|
Boca Raton, United States | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
Locations
6 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 8 | 1 |
| France | Ended | 8 | 9 |
| Germany | Ended | 14 | 6 |
| Hungary | Ended | 1 | 8 |
| Poland | Ended | 30 | 4 |
| Slovakia | Ended | 1 | 1 |
| Rest of world
India, Mexico, Argentina, United Kingdom, United States
|
— | 270 | — |
Investigational sites
Medical Plus s.r.o.
N/A, Obchodni 1507, 686 01, Uherske Hradiste
Centre Hospitalier Universitaire De Reims
Rhumatologie, 45 Rue Cognacq Jay, 51100, Reims
Departmental Hospital Vendee
Rhumatologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Les Hopitaux Universitaires De Strasbourg
Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Montpellier
Rhumatologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nimes
Rhumatologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Regional D'orleans
Rhumatologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Ass Hospitaliere Protestante De Lyon
Rhumatologie, 3 Chemin Du Penthod, 69300, Caluire-Et-Cuire
Assistance Publique Hopitaux De Paris
Rhumatologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Nice
Rhumatologie, 30 Voie Romaine, 06000, Nice
Rheumazentrum Ratingen
Studienambulanz, Calor-Emag-Strasse 3, Zentrum, Ratingen
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
N/A, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Institut Fuer Praeventive Medizin & Klinische Forschung GbR
Private Practise, Johannes-Schlaf-Strasse 35, Stadtfeld West, Magdeburg
University Hospital Cologne AöR
N/A, Kerpener Strasse 62, Lindenthal, Cologne
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
N/A, Goethestrasse 40, 18209, Bad Doberan
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentrum II - HRF II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Revita Kft.
N/A, Margit Korut 50-52 Fszt. 9, Kerulet, Budapest II
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
CRU Hungary Kft.
N/A, Petofi Ut 26a, 3860, Encs
Vital-Medicina Kft.
N/A, Jozsef Attila Utca 17, 8200, Veszprem
Regia Med Kft.
N/A, Bregyo Koz 5, 8000, Szekesfehervar
Kistarcsai Flor Ferenc Korhaz
Reumatologia, Semmelweis Ter 1, 2143, Kistarcsa
Vasarhelyi Sarkanyfu Kft.
N/A, Nagy Sandor Utca 11, 6800, Hodmezovasarhely
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Nzoz Bif-Med
NA, ul. Stefana Zeromskiego 18, Floor 2/ Room 25, Bytom
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
NA, Ul Prowiantowa 15/4, 15-707, Bialystok
Medicover Integrated Clinical Services Sp. z o.o.
NA, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Klinika Reuma Park Sp. z o.o. S.K.
NA, Aleja Wilanowska 333, 02-665, Warsaw
Cliniq s.r.o.
Rheumatology, Bezrucova 5, Stare Mesto, Bratislava
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 | 2023-09-07 | 2026-04-22 | 2023-09-14 | 2025-08-20 | |
| France | 2023-10-13 | 2025-01-16 | 2023-12-05 | 2024-07-12 | |
| Germany | 2023-09-04 | 2025-07-24 | 2024-02-08 | 2025-07-23 | |
| Hungary | 2025-01-24 | 2026-04-15 | 2025-01-30 | 2025-08-20 | |
| Poland | 2025-01-31 | 2026-04-15 | 2025-02-05 | 2025-08-20 | |
| Slovakia | 2024-04-19 | 2024-08-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 61 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D4_Patient Documents Copyright Template | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute SIF HH_slovak | 1.1 |
| Protocol (for publication) | LY3871801 FTAF_a Harmonized Clinical Protocol_Redacted_for publication | 2 |
| Protocol (for publication) | LY3871801 FTAF_a_Protocol_Redacted | A |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_List of planned sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Informed consent and patient recruitment procedure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment and Informed consent procedure_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Hibbert Appreciation Items Listing | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Doctor to Doctor Letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Doctor to Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL BROCHURE_MASTER_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_Redacted | 3 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland | 1 |
| Subject information and informed consent form (for publication) | D4_Patient Information Card | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 2a_PL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 2a_PL_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 2b_PL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 2b_PL_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Phase 2a_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Phase 2b_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Phase 2a_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Phase 2b_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Czech EC_packet_w_Data_Laws_as_applied_to_GP | 7 |
| Subject information and informed consent form (for publication) | L2_Czech Greenphire ClinCard Msg Templates_ROW v6 Feb 2018 | 6 |
| Subject information and informed consent form (for publication) | L2_Czech Greenphire_ClinCard_Card_Carrier_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Czech Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Czech Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Czech Template Greenphire EU Generic ClinCard_v3 April 2019 | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Actigraphy Patient Training | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Participant Welcome Letter | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Study Guide_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Visit Card_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU 125g_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card 2a | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card 2b | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You card_Dropout | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You card_End Of Study | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You card_Participation | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You card_Screening | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Participant Dosing Instructions | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Card_Redacted | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_a_SK_2022-502994-40-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2022-502994-40-00_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2022-502994-40-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FRE_2022-502994-40-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GER_2022-502994-40-00_FTAF_a_Clean_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2022-502994-40-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-502994-40-00_Redacted | 1.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-19 | Germany | Acceptable 2023-08-07
|
2023-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-18 | Acceptable | 2023-10-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-09-18 | Acceptable | 2023-11-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-19 | Germany | Acceptable | 2023-10-31 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-20 | Acceptable | 2023-11-07 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-19 | Germany | Acceptable | 2024-02-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-27 | Germany | Acceptable | 2024-05-03 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-10-01 | Acceptable 2023-08-07
|
2024-11-19 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-10-01 | 2025-01-11 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-07 | Acceptable | 2025-01-21 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-10 | Acceptable | 2025-03-21 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-01 | Acceptable | 2025-05-01 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-29 | Germany | Acceptable | 2025-05-29 |