Clinical trial • Phase II • Immunology
AZD1163 for Rheumatoid arthritis
Phase II trial of AZD1163 for Rheumatoid arthritis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 11-12-2025
- First CTIS Authorization Date
- 22-04-2026
Trial design
Randomised, azd1163 placebo (placebo comparator). dose and schedule not specified in ctis data.-controlled Phase II trial in Bulgaria, Germany, Hungary and others.
- Randomised
- Yes
- Comparator
- AZD1163 Placebo (placebo comparator). Dose and schedule not specified in CTIS data.
- Target Sample Size
- 198
- Trial Duration For Participant
- 730
Eligibility
Recruits 198 No vulnerable population selected; no specific vulnerable population consent or assent handling described..
- Vulnerable Population
- No vulnerable population selected; no specific vulnerable population consent or assent handling described.
Inclusion criteria
- {"criterion_text":"- Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.\n- Moderately-to-severely active RA as defined by: a. >= 6 swollen joints on 66SJC and >= 6 tender joints on 68TJC; b. CRP > upper limit of normal.\n- Have a positive ACPA at screening.\n- A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2 TNFi.\n- A history of at least 12 weeks treatment and >= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomisation."}
Exclusion criteria
- {"criterion_text":"- History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren’s disease are eligible.\n- Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12","definition_or_measurement_approach":"Change from baseline in DAS28-CRP measured at Week 12 (DAS28 calculated using CRP)."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12 - Percentage of Participants Achieving ACR50 at Week 12 - Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 - Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12","definition_or_measurement_approach":"Percentages achieving ACR20 and ACR50 at Week 12; change from baseline in CDAI and SDAI at Week 12."}
- {"endpoint_text":"- AZD1163 concentrations in serum.","definition_or_measurement_approach":"Serum concentration measurements of AZD1163 (PK sampling)."}
- {"endpoint_text":"- ADA (incidence, prevalence, and titres)","definition_or_measurement_approach":"Anti-drug antibody (ADA) assessments: incidence, prevalence and titres."}
Recruitment
- Planned Sample Size
- 198
- Recruitment Window Months
- 26
- Consent Approach
- Informed consent obtained from adult participants; subject information and informed consent forms are listed in trial documents (adult ICFs). No assent or under-18 consent arrangements described in CTIS data.
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 97
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 23
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of rheumatology
- Principal Investigator Name
- Mariana Ivanova Goycheva
- Principal Investigator Email
- mariana_ig@abv.bg
- Contact Person Name
- Mariana Ivanova Goycheva
- Contact Person Email
- mariana_ig@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- Rheumatology department
- Principal Investigator Name
- Tihomir Gorchev
- Principal Investigator Email
- dr.gorchev@gmail.com
- Contact Person Name
- Tihomir Gorchev
- Contact Person Email
- dr.gorchev@gmail.com
- Site Name
- Medici Sofia Medical Centre Ltd.
- Principal Investigator Name
- Georgi Kotov
- Principal Investigator Email
- gnkotov1@gmail.com
- Contact Person Name
- Georgi Kotov
- Contact Person Email
- gnkotov1@gmail.com
- Site Name
- Mbal Lyulin EAD
- Department Name
- Department of rheumatology
- Principal Investigator Name
- Aneliya Radikova
- Principal Investigator Email
- a.radikova@mail.bg
- Contact Person Name
- Aneliya Radikova
- Contact Person Email
- a.radikova@mail.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of rheumatology
- Principal Investigator Name
- Borislava Zhelezarova-Vasileva
- Principal Investigator Email
- borislavav@yahoo.com
- Contact Person Name
- Borislava Zhelezarova-Vasileva
- Contact Person Email
- borislavav@yahoo.com
- Site Name
- Medical Center Medtech Services Ltd.
- Principal Investigator Name
- Krasimir Kraev
- Principal Investigator Email
- dr_k.kraev@abv.bg
- Contact Person Name
- Krasimir Kraev
- Contact Person Email
- dr_k.kraev@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- Department of rheumatology
- Principal Investigator Name
- Boycho Oparanov
- Principal Investigator Email
- oparanov@abv.bg
- Contact Person Name
- Boycho Oparanov
- Contact Person Email
- oparanov@abv.bg
Germany
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 22
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- St. Josef Stift GmbH
- Department Name
- Klinik für Rheumatologie und Klinische Immunologie
- Principal Investigator Name
- Peter Korsten
- Principal Investigator Email
- p.korsten@st-josef-stift.de
- Contact Person Name
- Peter Korsten
- Contact Person Email
- p.korsten@st-josef-stift.de
- Site Name
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
- Department Name
- HRF II – Hamburger Rheuma Forschungszentrum II
- Principal Investigator Name
- Andrea Everding
- Principal Investigator Email
- everding@hotmail.de
- Contact Person Name
- Andrea Everding
- Contact Person Email
- everding@hotmail.de
- Site Name
- Rheumatologische Schwerpunktpraxis
- Principal Investigator Name
- Jan Brandt-Jürgens
- Principal Investigator Email
- jan.brandt-juergens@charite.de
- Contact Person Name
- Jan Brandt-Jürgens
- Contact Person Email
- jan.brandt-juergens@charite.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 43
- Number Of Sites
- 9
- Number Of Participants
- 19
Sites
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Reumatológia és Mozgásszervi Rehabilitációs Osztály
- Principal Investigator Name
- Péter Keszthelyi
- Principal Investigator Email
- keszthelyi.peter@bmkk.eu
- Contact Person Name
- Péter Keszthelyi
- Contact Person Email
- keszthelyi.peter@bmkk.eu
- Site Name
- Vital-Medicina Kft.
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- dr.dreschere@gmail.com
- Contact Person Name
- Edit Drescher
- Contact Person Email
- dr.dreschere@gmail.com
- Site Name
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
- Department Name
- Klinikai Farmakológia
- Principal Investigator Name
- Bernadette Rojkovich
- Principal Investigator Email
- dr.rojkovich.bernadette@gmail.com
- Contact Person Name
- Bernadette Rojkovich
- Contact Person Email
- dr.rojkovich.bernadette@gmail.com
- Site Name
- University Of Szeged
- Department Name
- Reumatológiai és Immunológiai Klinika
- Principal Investigator Name
- Attila Balog
- Principal Investigator Email
- balog.attila@med.u-szeged.hu
- Contact Person Name
- Attila Balog
- Contact Person Email
- balog.attila@med.u-szeged.hu
- Site Name
- Qualiclinic Kft.
- Principal Investigator Name
- István Szombati
- Principal Investigator Email
- i.szombati@qclinic.hu
- Contact Person Name
- István Szombati
- Contact Person Email
- i.szombati@qclinic.hu
- Site Name
- University Of Debrecen
- Department Name
- Reumatológiai és Immunológiai Klinika
- Principal Investigator Name
- Nóra Bodnár
- Principal Investigator Email
- drbodnarnora@gmail.com
- Contact Person Name
- Nóra Bodnár
- Contact Person Email
- drbodnarnora@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Reumatológiai és Immunológiai Klinika
- Principal Investigator Name
- Péter Juhász
- Principal Investigator Email
- juhasz.peter.dr1@gmail.com
- Contact Person Name
- Péter Juhász
- Contact Person Email
- juhasz.peter.dr1@gmail.com
- Site Name
- Complex Rendelo Med Zrt.
- Principal Investigator Name
- Kata Kerekes
- Principal Investigator Email
- drkerekeskata@yahoo.com
- Contact Person Name
- Kata Kerekes
- Contact Person Email
- drkerekeskata@yahoo.com
- Site Name
- Malopolskie Badania Kliniczne Sp. z o.o.
- Principal Investigator Name
- Piotr Krawiec
- Principal Investigator Email
- p.krawiec@mbk.clinic
- Contact Person Name
- Piotr Krawiec
- Contact Person Email
- p.krawiec@mbk.clinic
Spain
- Earliest CTIS Part Ii Submission Date
- 24-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 29
- Number Of Sites
- 8
- Number Of Participants
- 19
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Rheumatology
- Principal Investigator Name
- Juan Carlos Cea
- Principal Investigator Email
- carlos.cea.pereiro@sergas.es
- Contact Person Name
- Juan Carlos Cea
- Contact Person Email
- carlos.cea.pereiro@sergas.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- Principal Investigator Name
- Antonio Fernández
- Principal Investigator Email
- afnebro@gmail.com
- Contact Person Name
- Antonio Fernández
- Contact Person Email
- afnebro@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Rheumatology
- Principal Investigator Name
- Jose Andrés Roman
- Principal Investigator Email
- roman_jan@gva.es
- Contact Person Name
- Jose Andrés Roman
- Contact Person Email
- roman_jan@gva.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Rheumatology
- Principal Investigator Name
- Hye Sang
- Principal Investigator Email
- HSang@santpau.cat
- Contact Person Name
- Hye Sang
- Contact Person Email
- HSang@santpau.cat
- Site Name
- Hospital Del Mar
- Department Name
- Rheumatology
- Principal Investigator Name
- Carolina Pérez
- Principal Investigator Email
- cperezg@hmar.cat
- Contact Person Name
- Carolina Pérez
- Contact Person Email
- cperezg@hmar.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Rheumatology
- Principal Investigator Name
- Maria América López
- Principal Investigator Email
- maria.lopezlasanta@vallhebron.cat
- Contact Person Name
- Maria América López
- Contact Person Email
- maria.lopezlasanta@vallhebron.cat
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Rheumatology
- Principal Investigator Name
- María Garcia-Manrique de Lara
- Principal Investigator Email
- mariagarciamanrique@gmail.com
- Contact Person Name
- María Garcia-Manrique de Lara
- Contact Person Email
- mariagarciamanrique@gmail.com
- Site Name
- Parc Del Tauli 1
- Department Name
- Rheumatology
- Principal Investigator Name
- María Garcia-Manrique de Lara
- Principal Investigator Email
- mariagarciamanrique@gmail.com
- Contact Person Name
- María Garcia-Manrique de Lara
- Contact Person Email
- mariagarciamanrique@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 21
- Number Of Sites
- 5
- Number Of Participants
- 22
Sites
- Site Name
- Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki
- Principal Investigator Name
- Marek Zawadzki
- Principal Investigator Email
- mareklek.9@wp.pl
- Contact Person Name
- Marek Zawadzki
- Contact Person Email
- mareklek.9@wp.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Kraków
- Principal Investigator Name
- Mariusz Korkosz
- Principal Investigator Email
- mcm.mariusz.korkosz@mp.pl
- Contact Person Name
- Mariusz Korkosz
- Contact Person Email
- mcm.mariusz.korkosz@mp.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
- Department Name
- MICS Centrum Medyczne Warszawa
- Principal Investigator Name
- Katarzyna Romanowska-Próchnicka
- Principal Investigator Email
- katarzynaromanowskaprochnicka@medycynakliniczna.pl
- Contact Person Name
- Katarzyna Romanowska-Próchnicka
- Contact Person Email
- katarzynaromanowskaprochnicka@medycynakliniczna.pl
- Site Name
- Malopolskie Badania Kliniczne Sp. z o.o.
- Principal Investigator Name
- Piotr Krawiec
- Principal Investigator Email
- p.krawiec@mbk.clinic
- Contact Person Name
- Piotr Krawiec
- Contact Person Email
- p.krawiec@mbk.clinic
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Torun)
- Department Name
- MICS Centrum Medyczne Toruń
- Principal Investigator Name
- Sławomir Jeka
- Principal Investigator Email
- s.jeka@wp.pl
- Contact Person Name
- Sławomir Jeka
- Contact Person Email
- s.jeka@wp.pl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD1163
- Active Substance
- AZD1163
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus 1
- Investigational Product Name
- AZD1163 Placebo
- Modality
- Other
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