Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
420
Countries
5
Sites
26
Rheumatoid Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases
To evaluate the efficacy of peresolimab compared to placebo in achieving ACR20
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Apr 2023 → 17 Jan 2025
- Decision date (initial)
- 2023-02-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501425-20-00
- WHO UTN
- U1111-1283-9566
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenetic, Dose response, Efficacy, Pharmacodynamic, Pharmacokinetic, Safety
To evaluate the efficacy of peresolimab compared to placebo in achieving ACR20
Conditions and MedDRA coding
Rheumatoid Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases
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 5
- Had cancer within the last 5 years, except for some types of skin cancer or cervical cancer.
- Had cervical dysplasia.
- 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 1
- Percentage of Participants Achieving American College of Rheumatology (ACR)20 ACR20 – 20% improvement in the ACR core set values
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Humanised IGG1 Monoclonal Antibody Against PD-1
PRD9914421 · Product
- Active substance
- Humanised IGG1 Monoclonal Antibody Against PD-1
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 15000 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- 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
- 12 Week(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 7
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Other |
| Eurofins Panlabs Inc. ORG-100044318
|
Saint Charles, United States | Other |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifissia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100044131
|
Indianapolis, United States | Other |
Locations
5 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ended | 8 | 5 |
| Hungary | Ended | 16 | 3 |
| Italy | Not authorised | 7 | 2 |
| Poland | Ended | 27 | 10 |
| Spain | Ended | 11 | 6 |
| Rest of world
United States, Canada, Japan, China
|
— | 351 | — |
Investigational sites
Hippokration Hospital
2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, Vassilissas Sofias Avenue 114, 115 27, Athens
University General Hospital Of Alexandroupoli
First Department of Internal Medicine, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Laiko General Hospital Of Athens
1st Propaedeutic Internal Medicine Department, Agiou Thoma (goudi) 17, 115 27, Athens
University General Hospital Attikon
4th Department of Medicine/ Rheumatology and Immunology Unit, Rimini Street 1, 124 62, Athens
University General Hospital Of Heraklion
Clinic of Rheumatology and Clinical Immunology, Stavrakia And Voutes, 715 00, Heraklion
Revita Kft.
N/A, Margit Korut 50-52 Fszt. 9, Kerulet, Budapest II
Qualiclinic Kft.
N/A, Dereglye Utca 5 B, Ep I Em 3, Budapest
Vital-Medicina Kft.
N/A, Jozsef Attila Utca 17, 8200, Veszprem
Careggi University Hospital
SOD Reumatologia, Dipartimento di Medicina Sperimentale e Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Integrata Verona
Unità di Reumatologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia NCM, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
Nova Reuma Społka Partnerska, Ul Prowiantowa 15/4, 15-707, Bialystok
Niepubliczny Zaklad Opieki Zdrowotnej Bif Med
Rheumatology, Ul. Stefana Zeromskiego 18, 41-900, Bytom
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Ai Centrum Medyczne Sp. z o.o. S.K.
ai centrum medyczne sp. z o.o. sp.k., Ul. Swietojanska 1, 61-113, Poznan
Rheuma Medicus Sp. z o.o.
Rheuma Medicus Zaklad Opieki Zdrowotnej, Ul. Pruszkowska 6, 02-118, Warsaw
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia Poznanskie Centrum Medyczne, Ul. 1 Maja 38/39, 71-627, Szczecin
Ambulatorium Sp. z o.o.
Ambulatorium Sp. z o.o., Ul. Topolowa 28, 82-300, Elblag
Clinica Gaias Santiago
Reumathology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Hospital Universitario Marques De Valdecilla
Reumathology, 5 Planta, Avenida Valdecilla S/n, Santander
Complexo Hospitalario Universitario De Santiago
Reumathology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Quironsalud Infanta Luisa
Reumathology, Calle De San Jacinto 87, 41010, Sevilla
Complexo Hospitalario Universitario A Coruna
Reumathology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Basurto
Reumathology, Montevideo Etorbidea 16-18, 48013, Bilbao
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 |
|---|---|---|---|---|---|
| Greece | 2023-05-16 | 2023-05-17 | 2023-06-30 | ||
| Hungary | 2023-04-06 | 2023-04-12 | 2023-06-30 | ||
| Poland | 2023-04-12 | 2023-04-12 | 2023-06-30 | ||
| Spain | 2023-04-03 | 2023-04-18 | 2023-06-30 |
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 |
|---|---|---|---|
| J1A-MC-KDAF Final Summary of Results_2022-501425-20-00 SUM-107216
|
2025-11-19T23:23:27 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| J1A-MC-KDAF_Lay Person Summary of Results_2022-501425-20-00 | 2026-01-12T04:32:33 | Submitted | Laypersons Summary of Results |
| J1A-MC-KDAF_ Lay Person Summaries_Translated Copies (Italian, Hungarian, Spanish, Greek, Polish) | 2026-03-20T14:26:07 | Submitted | Laypersons Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | J1A-MC-KDAF_Lay Person Summary of Results_2022-501425-20-00 | 1 |
| Laypersons summary of results (for publication) | LY3462817 KDAF Plain Language Summary Greek | 1 |
| Laypersons summary of results (for publication) | LY3462817 KDAF Plain Language Summary Hungarian | 1 |
| Laypersons summary of results (for publication) | LY3462817 KDAF Plain Language Summary Italian | 1 |
| Laypersons summary of results (for publication) | LY3462817 KDAF Plain Language Summary Polish | 1 |
| Laypersons summary of results (for publication) | LY3462817 KDAF Plain Language Summary Spain | 1 |
| Summary of results (for publication) | J1A-MC-KDAF Final Summary of Results_2022-501425-20-00 | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-21 | Spain | Acceptable with conditions 2023-02-27
|
2023-02-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-03-08 | Spain | Acceptable 2023-04-03
|
2023-04-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-04-13 | Acceptable | 2023-05-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-04-13 | Acceptable | 2023-07-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-04-14 | Spain | Acceptable | 2023-05-29 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-04-18 | Acceptable | 2023-06-13 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-26 | Spain | 2023-07-26 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-14 | Spain | 2024-05-14 |