Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
785
Countries
7
Sites
30
Psoriatic Arthritis
- To evaluate long term safety and tolerability of Tildrakizumab in adult subjects with active PsA. - To evaluate long term efficacy of Tildrakizumab in adult subjects with active PsA by assessment of American College of Rheumatology response criteria.
Key facts
- Sponsor
- Sun Pharmaceutical Industries Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 6 Apr 2023 → ongoing
- Decision date (initial)
- 2023-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sun Pharmaceutical Industries Ltd
External identifiers
- EU CT number
- 2022-501480-41-00
- WHO UTN
- U1111-1284-9919
- ClinicalTrials.gov
- NCT04991116
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis, Safety, Prophylaxis, Therapy
- To evaluate long term safety and tolerability of Tildrakizumab in adult subjects with active PsA.
- To evaluate long term efficacy of Tildrakizumab in adult subjects with active PsA by assessment of American College of Rheumatology response criteria.
Conditions and MedDRA coding
Psoriatic Arthritis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-000955-11 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1), Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze III, která prokáže účinnost a bezpečnost tildrakizumabu u pacientů léčených antiTNF s aktivní psoriatickou artritidou I (INSPIRE 1), Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie 3. fázy s číslom I na preukázanie účinnosti a bezpečnosti tildrakizumabu u subjektov s aktívnou psoriatickou artritídou v minulosti liečených inhibítormi TNF (INSPIRE 1), Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie 3. fázy s číslom I na preukázanie účinnosti a bezpečnosti tildrakizumabu u subjektov s aktívnou psoriatickou artritídou v minulosti liečených inhibítormi TNF (INSPIRE 1), Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie 3. fázy s číslom I na preukázanie účinnosti a bezpečnosti tildrakizumabu u subjektov s aktívnou psoriatickou artritídou v minulosti liečených inhibítormi TNF (INSPIRE 1) | |
| 2012-001377-88 | A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222 / MK-3222), Followed by an Optional Long Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011), 52 hetes, 3. fázisú, randomizált, aktív összehasonlító gyógyszer és placebo kontrollos, párhuzamos elrendezésű vizsgálat a subcutan alkalmazású Tildrakizumab (SCH 900222/MK-3222) hatásosságának és biztonságosságának/tolerálhatóságának kiértékelésére, amelyet egy opcionális, a hosszú távú biztonságosságot érintő, kiterjesztett vizsgálat követ, közepestől súlyosig terjedő, krónikus, plakk típusú pikkelysömörben szenvedő betegeknél (protokollszám: MK-3222-011), 52tydenni, randomizovana studie faze 3 kontrolovana aktivnim komparatorem a placebem, s paralelnim usporadanim, ke zhodnoceni ucinnosti a bezpecnosti/snasenlivosti podkozniho tildrakizumabu (SCH 900222/MK-3222), nasledovana nepovinnym prodlouzenim studie k hodnoceni dlouhodobe bezpecnosti, u subjektu se stredne vaznou az vaznou chronickou plakovitou psoriazou (cislo protokolu MK-3222-011) | |
| 2019-003551-11 | A Multicenter, Randomized, Placebo and Active Comparator-Controlled Clinical trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects from 6 to <18 Years of Age with Moderate to Severe Chronic Plaque Psoriasis, Ensayo clínico multicéntrico, aleatorizado, controlado con comparador activo y con placebo para estudiar la eficacia, seguridad y farmacocinética de tildrakizumab en sujetos pediátricos de 6 a <18 años de edad con psoriasis en placas crónica de moderada a grave | |
| 2020-000956-37 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naive Subjects with Active Psoriatic Arthritis II (INSPIRE 2) | |
| 2016-003937-62 | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Active Psoriatic Arthritis, Estudio de Fase IIb aleatorizado, con doble enmascaramiento, controlado con placebo y con dosis múltiples para demostrar la seguridad y la eficacia de tildrakizumab en sujetos con artritis psoriásica activa | |
| 2012-002255-42 | A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010) | |
| 2018-001060-35 | A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab, Estudio de extensión a largo plazo con dosis múltiples para demostrar la seguridad y la eficacia del tildrakizumab en sujetos con artritis psoriásica y espondilitis anquilosante o espondiloartritis axial no radiográfica que hayan completado previamente estudios con tildrakizumab |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Subjects possess the ability to understand the requirements of the study
- Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC
- Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments
- Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.
Exclusion criteria 4
- Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception
- Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP
- Subject has previously been enrolled in this long-term extension study
- Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Safety - Incidence and intensity of adverse events recorded through the study period
- Efficacy - Achieving ACR 20, ACR 50 and ACR 70
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ilumetri 100 mg solution for injection in pre-filled syringe
PRD6648170 · Product
- Active substance
- Tildrakizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 108 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC17 — -
- Marketing authorisation
- EU/1/18/1323/002
- MA holder
- ALMIRALL, S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sun Pharmaceutical Industries Limited
- Sponsor organisation
- Sun Pharmaceutical Industries Limited
- Address
- 1 Plot No 201 B, Western Express Highway, Goregaon East Western Express Highway Goregaon East
- City
- Mumbai
- Postcode
- 400063
- Country
- India
Scientific contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Shantanu Mehta
Public contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Shantanu Mehta
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Oracle India Private Limited ORG-100044568
|
Gurugram, India | Interactive response technologies (IRT) |
| Iqvia Biotech Limited ORG-100022665
|
Reading, United Kingdom | On site monitoring, Code 10, Code 11, Code 12, Code 2, Code 5, Data management, Code 8 |
| Docs24 Limited ORG-100042273
|
Edinburgh, United Kingdom | Other |
| Taxi Travel Ticket S.L. ORG-100042292
|
Barcelona, Spain | Other |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| WCG Munchen GmbH ORG-100027478
|
Munich, Germany | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Code 13 |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Code 13 |
| Oracle India Private Limited ORG-100044568
|
Gurugram, India | E-data capture |
Locations
7 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 56 | 4 |
| Estonia | Ongoing, recruitment ended | 18 | 3 |
| Germany | Ongoing, recruitment ended | 10 | 2 |
| Italy | Ended | 20 | 1 |
| Poland | Ongoing, recruitment ended | 132 | 10 |
| Slovakia | Ongoing, recruitment ended | 9 | 2 |
| Spain | Ongoing, recruitment ended | 28 | 8 |
| Rest of world
Canada, India, Korea, Republic of, Australia, Russian Federation, Taiwan, United States, Japan
|
— | 512 | — |
Investigational sites
Revmatologie s.r.o.
Rheumatology, Halasovo Namesti 597/1, Lesna, Brno-Sever
Revmatologicky Ustav
Rheumatology, Na Slupi 450/4, Nove Mesto, Prague 2
PV Medical Services s.r.o.
Rheumatology, Stefanikova 477, 760 01, Zlin
MuDr. Zuzana Stejfova
MUDr. Zuzana Štejfová, Taborska 325/57, Nusle, Prague
Kliiniliste Uuringute Keskus OÜ
N/A, Sobra Tn 54/1, 50106, Tartu Linn
MediTrials OÜ
N/A, L. Koidula Tn 5, 51006, Tartu Linn
Innomedica OÜ
N/A, Louna Tn 51a, 11617, Nomme Linnaosa
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Internal medicine and rheumatology, Claudiusstrasse 45, Wanne, Herne
Rheumatologische Schwerpunktpraxis
Rheumatologische Schwerpunktpraxis, Bundesallee 104-105, Friedenau, Berlin
Azienda Ospedaliera Universitaria Integrata Verona
UOC Reumatologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Centrum Medyczne Oporow
Centrum Medyczne Oporow, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Outpatient Clinic, Ul. Wiejska 81, 15-351, Bialystok
Rheuma Medicus Sp. z o.o.
Outpatient Clinic, Ul. Pruszkowska 6, 02-118, Warsaw
Mak-Med Clinic Sp. z o.o.
Outpatient Clinic, Ul. Wisniowa 22, 05-830, Nadarzyn
Reumed Sp. z o.o.
Outpatient Clinic, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Ai Centrum Medyczne Sp. z o.o. S.K.
Outpatient Clinic, Ul. Swietojanska 1, 61-113, Poznan
Centrum Medyczne All-Med Badania Kliniczne
Outpatient Clinic, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Medicover Integrated Clinical Services Sp. z o.o.
Outpatient Clinic, Ul. Stefana Batorego 18/22, 87-100, Torun
Clinicmed Daniluk, Nowak Sp. j.
Outpatient Clinic, Ul. Stoleczna 7/200, 15-879, Bialystok
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A., Ul. 1 Maja 13 C, 10-117, Olsztyn
Reum.hapi s.r.o.
Reumatologicka ambulancia, Tematinska 24, 915 01, Nove Mesto Nad Vahom
Medman s.r.o.
Reumatologicka ambulancia, Thurzova 437/15, 036 01, Martin
Hospital Universitario Virgen De Valme
Reumatology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario Reina Sofia
Reumatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario La Paz
Rheumatology, Paseo De La Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario A Coruna
Reumatology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Regional De Malaga
Reumatology, Avenida De Carlos De Haya S/n, 29010, Malaga
Complexo Hospitalario Universitario De Santiago
Reumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico Universitario De Valencia
Rheumatology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Quironsalud Sagrado Corazon
Reumatology, Calle De Rafael Salgado 3, 41013, Sevilla
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 | 2023-08-31 | 2023-10-19 | 2025-11-13 | ||
| Estonia | 2023-07-19 | 2023-08-08 | 2025-10-08 | ||
| Germany | 2023-10-05 | 2023-10-12 | 2025-10-21 | ||
| Italy | 2024-04-24 | 2025-10-14 | 2024-04-29 | 2025-08-20 | |
| Poland | 2023-04-14 | 2023-06-06 | 2025-11-28 | ||
| Slovakia | 2023-04-06 | 2023-09-29 | 2025-03-24 | ||
| Spain | 2023-06-06 | 2023-06-21 | 2025-07-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 175 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PCL_2022-501480-41-00_Change in MM_Redacted | 1 |
| Protocol (for publication) | D1_PCL_2022-501480-41-00_Exclusion Criteria_Redacted | 1 |
| Protocol (for publication) | D1_PCL_2022-501480-41-00_IP picture_Redacted | 1 |
| Protocol (for publication) | D1_Protocol addendum_2022-501480-41-00_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2022-501480-41-00_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_AU5_1 | 1 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_AU5_1 | 1 |
| Protocol (for publication) | D4_Patient facing documents_eCOA Tablet_BASDAI | 1 |
| Protocol (for publication) | D4_Patient facing documents_eCOA Tablet_Patient Pain VAS | 1 |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue_eCOA Tablet | 1 |
| Protocol (for publication) | D4_Patient facing documents_HAQ-DI_eCOA Tablet | 1 |
| Protocol (for publication) | D4_Patient facing documents_PGAofDA_eCOA Tablet | 1 |
| Protocol (for publication) | D4_Patient facing documents_SF36v2AT_eCOA Tablet | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet Training Module_eCOA Tablet | 1 |
| Protocol (for publication) | D4_Patient facing documents_WPAI PsA_eCOA Tablet | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Main Adult ICF_redacted | 3-4-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Covid-19_ redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Covid19_ru_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 3.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ru_Redacted | 3.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ICF | 1-3-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Adult Main_redacted | v3-4-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ COVID-19 Emergency Measures Adult ICF | v1-3-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Partner ICF_redacted | V1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult ICF Add_COVID-19 Emergency measures_TC | V1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Main_TC | V3-3-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Covid-19 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Emergency Measures ICF_Spain_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Covid-19_CLEAN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Covid-19_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Covid19_et_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Addendum COVID-19 | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult ICF_Spain_Redacted | 3.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CLEAN_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_et_Redacted | 3.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Highlighted_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_et_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_ru_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Spain_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_TC | V1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CLEAN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_CLEAN_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_Highlighted_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_red | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_TC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other patient facing material_Patient Pain VAS_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ Deactivation_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ LDI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ LEI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ NAPSI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ PASI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ PGA-PSO_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_ PhGADA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other site information material_66-68 Joint Count_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _C-SSRS-SinceLastVisit | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Deactivation_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _eCOA Tablet_Patient Pain VAS | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _eCOA Tablet_PGAofDA | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _GP Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _LDI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _NAPSI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _PASI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Patient ID Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _PGA-PSO_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _PhGADA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Record for Self Administration | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Self Injection Instructions | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _SF36v2AT_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Tablet Training Module_eCOA Tablet | 3.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _WPAI PsA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _WPAI PsA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ eCOA Tablet_BASDAI | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ eCOA Tablet_Patient Pain VAS | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ FACIT-Fatigue_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ GP Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ HAQ-DI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Master Patient ID Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Record for Self Administration | v2-1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Self Injection Instructions | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Tablet Training Module_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ WPAI PsA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_66-68 Joint Count_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_66-68 Joint Count_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_BASDAI_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_BASDAI_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS_eCOA_et | 14.01.09 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS_eCOA_ru | 14.01.2009 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-SinceLastVisit | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-SinceLastVisit_AU5-1 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Deactivation_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA Tablet_BASDAI | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA Tablet_BASDAI | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA Tablet_Patient Pain VAS | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA Tablet_PGAofDA | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA Tablet_PGAofDA | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACIT-Fatigue_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACIT-Fatigue_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACIT-Fatigue_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACIT-Fatigue_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HAQ-DI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HAQ-DI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HAQ-DI_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HAQ-DI_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LDI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LEI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LEI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Master Patient ID Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_NAPSI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PASI_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID card_et | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID card_ru | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Pain VAS_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGA-PSO_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGAofDA_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGAofDA_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PhGADA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Record for Self Administration_et | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Record for Self Administration_ru | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Record_for_Self_Administration | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Self Injection Instructions | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Self Injection Instructions_et | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Self Injection Instructions_ru | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SF36v2AT_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SF36v2AT_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SF36v2AT_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SF36v2AT_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tablet Training Module_eCOA Tablet | 2.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tablet Training_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Training Module_eCOA_ru | 2.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI PsA_eCOA Tablet | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI PsA_eCOA_et | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI PsA_eCOA_ru | 1.00 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_66-68 Joint Count_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_BASDAI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_C-SSRS-SinceLastVisit | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Deactivation_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_FACIT-Fatigue_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_GP Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_HAQ-DI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LDI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LEI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_NAPSI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_PASI_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Patient ID Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Patient Pain VAS_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_PGA-PSO_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_PGAofDA_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_PhGADA_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Record for self admin | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Self inj instr | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_SF36v2AT_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Tablet Train Mod_eCOA Tablet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_WPAI PsA_eCOA Tablet | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Ilumetri | 1 |
| Synopsis of the protocol (for publication) | D1_Long Protocol Synopsis_CZ_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EE_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2022-501480-41-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2022-501480-41-00_Redacted | 1 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-20 | Germany | Acceptable 2023-02-20
|
2023-02-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-01 | Acceptable | 2023-08-07 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-06-01 | Acceptable | 2023-07-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-06-20 | Acceptable | 2023-07-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-06-21 | Acceptable | 2023-08-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-08-04 | Germany | Acceptable | 2023-08-18 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-11 | Germany | 2023-09-11 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-09-13 | Acceptable | 2023-09-29 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2023-10-17 | Acceptable 2023-02-20
|
2023-12-22 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-05-28 | Germany | Acceptable 2024-07-26
|
2024-07-29 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-11 | Germany | Acceptable 2024-07-26
|
2025-01-11 |
| 12 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-03-04 | Acceptable | 2025-04-08 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-30 | Germany | Acceptable | 2025-12-30 |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-02-12 | Germany | Acceptable 2026-03-23
|
2026-03-23 |