Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruiting
Participants planned
3,041
Countries
12
Sites
122
Moderate to Severe Plaque Psoriasis
Assess the cardiovascular safety of long-term use of deucravacitinib in comparison to ustekinumab in adults with moderate-to-severe plaque psoriasis
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 May 2026 → ongoing
- Decision date (initial)
- 2026-01-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2023-503766-24-00
- WHO UTN
- U1111-1291-5815
- ClinicalTrials.gov
- NCT07116967
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Assess the cardiovascular safety of long-term use of deucravacitinib in comparison to ustekinumab in adults with moderate-to-severe plaque psoriasis
Secondary objectives 1
- Assess the safety of long-term use of deucravacitinib in comparison to ustekinumab in adults with moderate-to-severe plaque psoriasis
Conditions and MedDRA coding
Moderate to Severe Plaque Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult participants aged 40 years or older (inclusive)
- Participants with moderate-to-severe plaque psoriasis as defined by a PASI ≥ 12, BSA ≥ 10% and sPGA score ≥ 3 at the time of the Screening Visit and Day 1 visits
- Participants who are candidates for phototherapy or systemic treatment of psoriasis
- Eligible participants should have at least 1 of the following cardiovascular risk factors: Current cigarette smoker, Diagnosis of hypertension or use of blood pressure-lowering medications, Diagnosis of dyslipidemia, Diabetes mellitus type 1 or 2, History of 1 or more of the following CVD events: coronary revascularization procedures including PCI or CABG, MI, cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack, Obesity defined by a body mass index ≥ 30 kg/m2, Family history of premature coronary heart disease
Exclusion criteria 2
- Recent history of 1 or more of the following cardiovascular events: MI, stroke, history of coronary revascularization, or VTE within 90 days prior to Day 1
- Evidence of active cancer or a history of cancer or lymphoproliferative disease within the previous 5 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization
Secondary endpoints 3
- Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster
- SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation
- Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9836762 · Product
- Active substance
- Deucravacitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 10950 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
SUB27761 · Substance
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 90 mg/ml milligram(s)/millilitre
- Max total dose
- 2070 mg/ml milligram(s)/millilitre
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labelled and repackaged
SUB27761 · Substance
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 45 mg/ml milligram(s)/millilitre
- Max total dose
- 1035 mg/ml milligram(s)/millilitre
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labelled and repackaged
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Code 13, Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
Locations
12 EU/EEA countries · 122 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 18 | 3 |
| Bulgaria | Authorised, recruitment pending | 71 | 4 |
| Czechia | Authorised, recruitment pending | 165 | 10 |
| Denmark | Authorised, recruitment pending | 23 | 5 |
| France | Ongoing, recruiting | 10 | 3 |
| Germany | Ongoing, recruiting | 227 | 28 |
| Hungary | Authorised, recruiting | 89 | 9 |
| Italy | Authorised, recruiting | 42 | 7 |
| Poland | Authorised, recruitment pending | 458 | 30 |
| Romania | Authorised, recruitment pending | 81 | 10 |
| Spain | Authorised, recruiting | 93 | 10 |
| Sweden | Authorised, recruitment pending | 12 | 3 |
| Rest of world
Mexico, United Kingdom, Canada, Brazil, Japan, Taiwan, Chile, United States, China, Australia, Korea, Republic of, Argentina
|
— | 1,752 | — |
Investigational sites
Universitair Ziekenhuis Gent
Dermatology, Corneel Heymanslaan 10, 9000, Gent
Associatie dermatologie Maldegem
Dermatology, Brugse Steenweg 181a, 9990, Maldegem
Cliniques Universitaires Saint-Luc
Dermatology, Avenue Hippocrate 10, 1200, Bruxelles
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
clinic – medical oncology, level III, Oborishte Distr., Ul.Byalo More 8, Sofia
Medical Center Medconsult Pleven OOD
Dermatology, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Medical Center MedConsult - Burgas
Dermatology, 40 G.S.Rakovski str., 8000, Burgas
Medical Center MedConsult - Lovech
Dermatology, 27 Sajko Saev St., 5500, Lovech
prof. MUDr. Petr Arenberger
Dermatovenerologicka ambulance, Bolzanova 1604/7, 11000, Praha 1
CCR Ostrava s.r.o.
NA, 28. Rijna 3348/65, Moravska Ostrava, Moravska Ostrava A Privoz
Praglandia s.r.o.
NA, Nadrazni 3368/30a, Smichov, Prague
MUDr. Petr Trestik
Dermatovenerologicka ambulance, Hranicni 2118/9, 56802, Svitavy
Clintrial s.r.o.
NA, Pocernicka 1427/16, Strasnice, Prague 10
Dermamedica s.r.o.
NA, Komenskeho 420, 547 01, Nachod
Krajska zdravotni a.s.
Kozni oddeleni, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Fakultni Nemocnice Kralovske Vinohrady
Dermatovenerologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Nemocnice AGEL Novy Jicin a.s.
Kozni oddeleni se stacionarem, Purkynova 2138/16, 741 01, Novy Jicin
Pratia Prague s.r.o.
NA, Vinohradska 1597/174, Vinohrady, Prague 3
Aalborg University Hospital
Dept. of Dermatology and Venereology, Aalborg University Hospital, Denmark, Moelleparkvej 4, 9000, Aalborg
Gentofte Hospital
Departemnt of dermatology and Allergy, Herlev and Gentofte Hospital, Denmark, Gentofte Hospitalsvej 15, 2900, Hellerup
Sanos A/S
Sanos Clinic Herlev, Herlev Hovedgade 82, 2730, Herlev
Region Hovedstaden
Department of Dermatology, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Midtjylland
Department of Dermatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire De La Reunion
Dermatologie, 97 Avenue President Mitterrand, Bp 350, Saint-Pierre
Tagast 41
Dermatologie, 2 Boulevard Victor Hugo, 06000, Nice
Centre Hospitalier Universitaire De Nantes
Dermatologie, 1 Place Alexis Ricordeau, 44000, Nantes
Thermalsole und Schwefelbad Bentheim GmbH
Klinisches Studienzentrum, Am Bade 1, 48455, Bad Bentheim
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Eurofins bioskin GmbH
NA, Messberg 4, Hamburg-Altstadt, Hamburg
Universitaetsklinikum Schleswig-Holstein AöR
Zentrum für entzündliche Hauterkrankungen, Schwanenweg 20, Duesternbrook, Kiel
Studienzentrum Dr. med. Beate Schwarz
Dermatologie und Allergologie, Bismarckstr. 49, 89129, Langenau
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
NA, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Hms GmbH
NA, Trierer Strasse 215-217, 66663, Merzig
Charite Universitaetsmedizin Berlin KöR
Inflammations- und Immundermatologie Charité (IIDC), Chariteplatz 1, Mitte, Berlin
Harzklinikum Dorothea Christiane Erxleben GmbH
Klinik für Dermatologie und Allergologie - Studienzentrum, Ditfurter Weg 24, 06484, Quedlinburg
Universitaetsklinikum Heidelberg AöR
Hautklinik, Im Neuenheimer Feld 440, Neuenheim, Heidelberg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Hautklinik und Poliklinik - Clinical Research Center (CRC), Langenbeckstrasse 1, Oberstadt, Mainz
Praxis Dr. Zarzou
NA, Große Steinstr. 12, 06108, Halle
Universitaetsklinikum Wuerzburg AöR
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Goethe University Frankfurt
Klinik für Dermatologie, Venerologie und Allergologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medical Center - University Of Freiburg
Klinik für Dermatologie und Venerologie, Hauptstrasse 7, Herdern, Freiburg Im Breisgau
Beldio Research GmbH
NA, Kramerstrasse 15, 87700, Memmingen
ISA Interdisciplinary Study Association GmbH
NA, Rankestrasse 33/34, Charlottenburg, Berlin
Medizinisches Versorgungszentrum DermaKiel GmbH
Studienabteilung, Schoenberger Strasse 72-74, Wellingdorf, Kiel
Studienzentrum an der Hase GbR
NA, Hasestraße 17, 49565, Bramsche
Derma-Study-Center Friedrichshafen GmbH
NA, Charlottenstrasse 12/1, 88045, Friedrichshafen
Studienzentrum KorSearch
NA, Schoenstr. 5-7, 13086, Berlin
Hautarztpraxis Dr. Hoffmann
NA, Annenstr. 151, 58453, Witten
Dermatologikum Hamburg GmbH
NA, Stephansplatz 5, Neustadt, Hamburg
BAG Dres. Quist PartG
NA, Haifa-Allee 20, 55128, Mainz
Universitaet Muenster
Klinik für Hautkrankheiten, ZID, Von-Esmarch-Strasse 48, 48149, Muenster
Universitaetsklinikum Tuebingen AöR
Universitäts-Hautklinik Sektion Dermatologische Onkologie, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsklinikum Erlangen AöR
Hautklinik - Studienambulanz, Ulmenweg 18, Innenstadt, Erlangen
Praxis Fuer Dermatologie Und Venerologie
NA, Hauptstrasse 36a, Innere Neustadt, Dresden
Uno Medical Trials Kft.
N/A, Vecsey Karoly Utca 39, 1152, Budapest
University Of Debrecen
Borgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Allergo-Derm Bakos Kft.
N/A, Baross Utca 20, 5000, Szolnok
University Of Szeged
Borgyogyaszat es Allergologiai Klinika, Koranyi Fasor 6, 6720, Szeged
Orvostudomanyi Kutato es Fejleszto Kft.
N/A, Dozsa Gyorgy Utca 25, 4027, Debrecen
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
DermaMed Research Kft.
N/A, Kossuth Lajos Utca 19, 5900, Oroshaza
Derma-B Kft.
N/A, Gyepusor Utca 3, 4031, Debrecen
Medmare Bt.
NA, Jozsef Attila Utca 15, 8200, Veszprem
Azienda Ospedaliero Universitaria Di Modena
Università di Modena e Reggio Emilia sc dermatology, Largo Del Pozzo 71, 41124, Modena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Dermatolgia, Largo Francesco Vito 1, 00168, Rome
Universita' Degli Studi G. D'Annunzio Di Chieti
Unit Dermatology, Via Luigi Polacchi 11, 66100, Chieti Scalo
Humanitas Mirasole S.p.A.
Unit Dermatology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Cagliari
UOC Dermatologia Universita' Cagliari, Via Ospedale N. 54, 09124, Cagliari
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Clinica Dermatologica, Via Sergio Pansini 5, 80131, Naples
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Dipartimento Biotecnologie e Scienze Cliniche, Ospedale Regionale San Salvatore, Via Lorenzo Natali 1, L'aquila
Klinika Ambroziak Sp. z o.o.
Dermatologia, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
EMC Instytut Medyczny S.A.
PL Certus Szpital Nr 1 PL Certus Ambulatoria, Ul. Grunwaldzka 156, 60-309, Poznan
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
N/A, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18-22, 87-100, Torun
Dermedic Jacek Zdybski
N/A, Henryka Sienkiewicza 65/14/II, 27-400, Ostrowiec Swietokrzyski
Futuremeds Sp. z o.o.
N/A, Ul. Sw. Wincentego 93 Lok. 5/6 7, 03-291, Warsaw
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
N/A, Ul. Szafirowa 15/lok 45, 20-573, Lublin
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Chlodna 52, 00-872, Warsaw
Centrum Medyczne Dr Rajzer Sp. z o.o.
N/A, Ul. Borkowska 29a/9, 30-438, Cracow
Pratia S.A.
N/A, Ul. Chrzanowskiego 3 Lok 5, 81-338, Gdynia
Pratia S.A.
N/A, Ul. Dabrowki 13, 40-081, Katowice
Specderm Poznanska Sp. j.
N/A, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
N/A, Ul. 1 Maja 13 C, 10-117, Olsztyn
St-Inspire Sp. z o.o.
N/A, Ul. Pszczynska 12b/1, 43-190, Mikolow
Provita Sp. z o.o.
N/A, Ul. Fabryczna 15b, 40-611, Katowice
Clinicmed Daniluk Nowak Sp. k.
N/A, Ul. Stoleczna 7/200, 15-879, Bialystok
Prywatny Gabinet Dermatologiczny Elżbieta Kłujszo
N/A, Ul. Generała Tadeusza Kościuszki 50 lok. 29, 25-316, Kielce
Clinical Research Group Sp. z o.o.
N/A, Ul. Sokolowska 9/u2, 01-142, Warsaw
Dermed Centrum Medyczne Sp. z o.o.
N/A, Ul. Piotrkowska 48, 90-265, Lodz
Clinical Best Solutions Sp. z o.o. S.K.
N/A, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
N/A, Ul. Studzienna 35-36/a, 82-300, Elblag
Velocity Skierniewice Sp. z o.o.
N/A, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Royalderm Agnieszka Nawrocka
N/A, ulica Krzysztofa Kieslowskiego 3B/3, 02-962, Warszawa
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
ZDROWIE OSTEO-MEDIC S.C. L. i A. Racewicz, A. i J. Supronik
N/A, ul. Wiejska 81, 15-351 Białystok
Wromedica I Bielicka A Strzalkowska s.c.
N/A, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Synexus Polska Sp. z o.o.
Oddział w Katowicach, Ul. Konckiego 3, 40-040, Katowice
Ai Centrum Medyczne Sp. z o.o.
N/A, Ul. Swietojanska 1, 61-113, Poznan
Dermmedica Sp. z o.o.
N/A, Ul. Krzysztofa Kolumba 6, 51-503, Wroclaw
Spitalul Clinic Colentina Bucuresti
Dermatology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Newderm Clinic S.R.L.
Dermatology, Intrarea Martir Ianos Paris, Nr. 11, Timisoara
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Dermatology, Bulevardul Tomis Nr 145, 900591, Constanta
Centrul Medical Dr. Ianosi
Dermatology, Calea București, Nr. 88, Craiova
Cabinet Medical Individual Lauderma
Dermatology, Bulevardul Chimiei Nr 4, 700291, Iasi
C.M.D.T.A Neomed
Dermatology, Strada Crisului nr.1, Romania, Brasov
Fundația Medicală Providența
Dermatology, Bulevardul Ștefan cel Mare si Sfant, Nr. 10, Iasi
Centrul Medical Sana S.R.L.
Dermatology, Strada Sergiu Dumitru Dr. Nr. 5, 011025, Bucharest
Spitalul Clinic Cf Nr.2 Bucuresti
Dermatology, Bulevardul Marasti Nr 63, 011464, Bucharest
Derma Luxury Style
Dermatology, Strada Pandurilor, Nr. 31, Reghin
Hospital Universitario 12 De Octubre
Dermatology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Salamanca
Dermatology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Germans Trias I Pujol
Dermatology, Carretera Canyet 1a Planta, 08916, Badalona
Futuremeds Spain S.L.
Dermatology, Calle De La Granja 8, 28003, Madrid
El Hospital Universitario De Gran Canaria Dr. Negrin
Dermatology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Virgen De La Macarena
Dermatology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinic De Barcelona
Dermatology, Calle Villarroel 170, 08036, Barcelona
Hospital Viamed Santa Ángela de la Cruz
Dermatology, Av. de Jerez, 59, Sevilla
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Dermatology, Calle De Serrano 143, 28006, Madrid
Hospital Vithas Parque San Antonio
Dermatology, Avenida Del Pintor Joaquin Sorolla 2, 29016, Malaga
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 |
|---|---|---|---|---|---|
| Belgium | 2026-05-26 | ||||
| France | 2026-05-28 | 2026-06-01 | |||
| Germany | 2026-05-26 | 2026-05-27 | |||
| Hungary | 2026-05-29 | ||||
| Italy | 2026-05-29 | ||||
| Spain | 2026-05-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 80 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Admin letter_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2023-503766-24-00_Redacted | PA02 EU |
| Protocol (for publication) | D4_Statement on protected questionnaire_TB Risk Assessment | N/A |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment arrangements_bg | 1 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_DK_Clean | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment material Brochure | 1 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment material Poster | 1 |
| Recruitment arrangements (for publication) | K2_Patient Database Letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_ES | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dan for DK_V1_26AUG2025_Bristol Myers Squibb Company_ IM011-1130_Clean | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_FR_Clean | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_ES | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_study brochure_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Fact Sheet_ES | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Participant who Becomes Pregnant | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF main_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF PP_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DK Add IC Right not to know_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_BG_v1_04Sep2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_EN_v1_04Sep2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DU-BE_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN-BE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR-BE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant IC_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_Clean_No redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_DU-BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_EN-BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FR_Clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FR-BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_BG_v1_4Sep2025 | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_EN_v1_4Sep2025 | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner IC_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Reimbursement IC _IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country IC Main_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_CZ_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy notice_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_sponsor statement_BE | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_DPN_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PDP_CZ_redacted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ustekinumab Stelara RSI and QUALITY | Rev 51 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-503766-24_CZ_CS_public | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503766-24_BG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24_ES | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24_HU | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24-00_DU-BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503766-24-00_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24-00_FR_BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24-00_FR_FRA | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503766-24-00_GER-BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503766-24-00_PL | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2023-503766-24_SE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT_2023-503766-24 RO | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_it_2023-503766-24_IT | 1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-16 | France | Acceptable 2026-01-19
|
2026-01-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-26 | Acceptable 2026-01-19
|
2026-01-26 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-02 | Acceptable 2026-01-19
|
2026-02-02 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-02 | Acceptable 2026-01-19
|
2026-02-02 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-02 | Acceptable 2026-01-19
|
2026-02-02 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-02 | France | Acceptable 2026-01-19
|
2026-02-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-02-02 | Acceptable 2026-01-19
|
2026-02-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-02 | Acceptable | 2026-02-16 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-02 | Acceptable | 2026-03-04 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-03 | Acceptable | 2026-02-25 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-17 | Acceptable | 2026-04-20 |