Clinical trial • Phase II • Immunology|Musculoskeletal

LUTIKIZUMAB for Rheumatoid arthritis

Phase II trial of LUTIKIZUMAB for Rheumatoid arthritis. Universal Placebo (Lutikizumab, Ravagalimab) (no dose/schedule specified)-controlled.

Overview

Trial Therapeutic Area
Immunology|Musculoskeletal
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
20-06-2025
First CTIS Authorization Date
12-09-2025

Trial design

Universal Placebo (Lutikizumab, Ravagalimab) (no dose/schedule specified)-controlled Phase II trial across 33 sites in Germany, Czechia, Hungary and others.

Comparator
Universal Placebo (Lutikizumab, Ravagalimab) (no dose/schedule specified)
Target Sample Size
96
Trial Duration For Participant
84

Eligibility

Recruits 96 Vulnerable population not selected; trial enrols adult participants only. Informed consent is obtained from participants (subject information and ICF documents are provided per country). No minors or assent procedures are described in the provided record..

Vulnerable Population
Vulnerable population not selected; trial enrols adult participants only. Informed consent is obtained from participants (subject information and ICF documents are provided per country). No minors or assent procedures are described in the provided record.

Inclusion criteria

  • {"criterion_text":"- At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/ tsDMARD is 2.\n- Participant must be on a stable dose of methotrexate (MTX)"}

Exclusion criteria

  • {"criterion_text":"- Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), unless they have been on stable doses for ≥ 1 week prior to Baseline Visit; and/or oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 4 weeks prior to Baseline Visit.\n- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12","definition_or_measurement_approach":"ACR50 response evaluated at Week 12 using the American College of Rheumatology 50% response criteria (assessed at Week 12)"}

Secondary endpoints

  • {"endpoint_text":"- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12\n- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12\n- Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) at Week 12\n- Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) at Week 12\n- Change from Baseline in DAS28 (CRP) at Week 12\n- Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) at Week 12\n- Percentage Of Participants Achieving CR per CDAI at Week 12","definition_or_measurement_approach":"Endpoints measured at Week 12 using standard ACR (ACR20/50/70), DAS28-CRP and CDAI criteria; change from baseline in DAS28(CRP) measured at Week 12."}

Recruitment

Planned Sample Size
108
Recruitment Window Months
15
Consent Approach
Informed consent is obtained from participants using subject information and informed consent forms provided per country (multiple country-specific ICF documents available, including main, optional, privacy and pregnancy ICFs and biomarker information forms). No assent for minors is described (trial enrolls adults).

Geography

Total Number Of Sites
33
Total Number Of Participants
108

Germany

Earliest CTIS Part Ii Submission Date
15-08-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
227
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Krankenhaus Porz Am Rhein gGmbH
Department Name
Klinik fuer Rheumatologie
Principal Investigator Name
Johannes Strunk
Principal Investigator Email
z.hoffmann@khporz.de
Contact Person Name
Johannes Strunk
Contact Person Email
z.hoffmann@khporz.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Principal Investigator Name
Andrea Everding
Principal Investigator Email
studienzentrum@hotmail.com
Contact Person Name
Andrea Everding
Contact Person Email
studienzentrum@hotmail.com
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin III
Principal Investigator Name
Alexander Pfeil
Principal Investigator Email
alexander.pfeil@med.uni-jena.de
Contact Person Name
Alexander Pfeil
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III mit den Schwerpunkten Onkologie, Haematologie und Rheumatologie
Principal Investigator Name
Valentin Schaefer
Principal Investigator Email
Wiebke.Heinemann@ukbonn.de
Contact Person Name
Valentin Schaefer
Contact Person Email
Wiebke.Heinemann@ukbonn.de
Site Name
Studienteam Lahn-Dill-Siegerland GbR
Department Name
Rheumateam Lahn-Dill-Siegerland
Principal Investigator Name
Mirko Steinmueller
Principal Investigator Email
kontakt@studienteam.de
Contact Person Name
Mirko Steinmueller
Contact Person Email
kontakt@studienteam.de
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Principal Investigator Name
Michaela Koehm
Principal Investigator Email
clinicalresearch@itmp.fraunhofer.de
Contact Person Name
Michaela Koehm

Czechia

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
42
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
PV Medical Services s.r.o.
Department Name
Revmatologicka ambulance
Principal Investigator Name
Petr Vitek
Principal Investigator Email
pv.medical@seznam.cz
Contact Person Name
Petr Vitek
Contact Person Email
pv.medical@seznam.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Principal Investigator Name
Libor Novosad
Principal Investigator Email
libor.novosad@email.cz
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz
Site Name
MEDICAL PLUS Research s.r.o.
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.cz
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.cz

Hungary

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Semmelweis University
Department Name
III. Reumatologiai Rehabilitációs Osztaly
Principal Investigator Name
Peter Balint
Principal Investigator Email
pvbalint@gmail.com
Contact Person Name
Peter Balint
Contact Person Email
pvbalint@gmail.com
Site Name
Qualiclinic Kft.
Principal Investigator Name
Gyongyi Tatar
Principal Investigator Email
info@qclinic.hu
Contact Person Name
Gyongyi Tatar
Contact Person Email
info@qclinic.hu
Site Name
Complex Rendelo Med Zrt.
Principal Investigator Name
Tunde Varga
Principal Investigator Email
vargatundedr1@gmail.com
Contact Person Name
Tunde Varga
Contact Person Email
vargatundedr1@gmail.com
Site Name
Revita Kft.
Principal Investigator Name
Marta Megyaszai
Principal Investigator Email
m.megyaszai@gmail.com
Contact Person Name
Marta Megyaszai
Contact Person Email
m.megyaszai@gmail.com
Site Name
University Of Szeged
Department Name
Reumatológiai és lmmunológiai 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
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

Spain

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
45
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Rheumatology
Principal Investigator Name
Jose Alvaro - Gracia
Principal Investigator Email
josemaria.alvarogarcia@salud.madrid.org
Contact Person Name
Jose Alvaro - Gracia
Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Principal Investigator Name
Eduard Graell Martin
Principal Investigator Email
graell.parctauli@gmail.com
Contact Person Name
Eduard Graell Martin
Contact Person Email
graell.parctauli@gmail.com
Site Name
Hospital Universitario Basurto
Department Name
Rheumatology
Principal Investigator Name
Maria Luz Garcia Vivar
Principal Investigator Email
marialuz.garciavivar@osakidetza.eus
Contact Person Name
Maria Luz Garcia Vivar
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Rheumatology
Principal Investigator Name
Cristina Campos Fernandez
Principal Investigator Email
campos_crifer@gva.es
Contact Person Name
Cristina Campos Fernandez
Contact Person Email
campos_crifer@gva.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Rheumatology
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
ricardo.blanco@scsalud.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Rheumatology
Principal Investigator Name
Francisco Blanco Garcia
Principal Investigator Email
fblagar@sergas.es
Contact Person Name
Francisco Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Reumatology
Principal Investigator Name
Rosalia Martinez Perez
Principal Investigator Email
rosalia.martinez.perez@gmail.com
Contact Person Name
Rosalia Martinez Perez
Site Name
Hospital Universitario Reina Sofia
Department Name
Reumatology
Principal Investigator Name
Ignacio Gomez Garcia
Principal Investigator Email
ignacio.gomez.sspa@juntadeandalucia.es
Contact Person Name
Ignacio Gomez Garcia

Poland

Earliest CTIS Part Ii Submission Date
18-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
32
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Principal Investigator Name
Katarzyna Kolossa
Principal Investigator Email
katarzyna.kolossa@mics.medicover.com
Contact Person Name
Katarzyna Kolossa
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Principal Investigator Name
Jan Brzezicki
Principal Investigator Email
janisb@poczta.onet.pl
Contact Person Name
Jan Brzezicki
Contact Person Email
janisb@poczta.onet.pl
Site Name
Malopolskie Centrum Kliniczne
Principal Investigator Name
Ewa Zimmer-Satora
Principal Investigator Email
ezimersatora@mck-krakow.pl
Contact Person Name
Ewa Zimmer-Satora
Contact Person Email
ezimersatora@mck-krakow.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Principal Investigator Name
Paula Sliwinska-Stanczyk
Principal Investigator Email
stanczyki@post.pl
Contact Person Name
Paula Sliwinska-Stanczyk
Contact Person Email
stanczyki@post.pl
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Principal Investigator Name
Magdalena Krajewska-Wlodarczyk
Principal Investigator Email
magdalenakrajewska@etykaosrodek.pl
Contact Person Name
Magdalena Krajewska-Wlodarczyk
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Principal Investigator Name
Rafal Wojciechowski
Principal Investigator Email
r.wojciechowski@wp.eu
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Principal Investigator Name
Mariusz Korkosz
Principal Investigator Email
mariusz.korkosz@uj.edu.pl
Contact Person Name
Mariusz Korkosz
Contact Person Email
mariusz.korkosz@uj.edu.pl

Slovakia

Earliest CTIS Part Ii Submission Date
18-12-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
25
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Thermium s.r.o.
Department Name
Rheumatology
Principal Investigator Name
Ivan Rybar
Principal Investigator Email
investigator.thermium1@gmail.com
Contact Person Name
Ivan Rybar
Site Name
Medman s.r.o.
Department Name
Rheumatology Outpatient Department
Principal Investigator Name
Viliam Manka
Principal Investigator Email
vilcoo@gmail.com
Contact Person Name
Viliam Manka
Contact Person Email
vilcoo@gmail.com
Site Name
Nemocnica AGEL Kosice Saca a.s.
Department Name
Rheumatology
Principal Investigator Name
Zuzana Lorinczova
Principal Investigator Email
zuzana.lorinczova@nke.agel.sk
Contact Person Name
Zuzana Lorinczova
Contact Person Email
zuzana.lorinczova@nke.agel.sk

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
IRT/global helpdesk; sponsorDuties code: 3; contact IRT-Global.Helpdesk@iqvia.com
Name
Cytel Inc.
Responsibilities
Independent Data Monitoring Committee
Name
WCG Clinical Inc.
Responsibilities
Anaphylaxis and Cardiovascular Adjudication Committee
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services; contact ctasubmissions@labcorp.com
Name
Medidata Solutions Inc.
Responsibilities
ePRO
Name
Veeva Systems Inc.
Responsibilities
CDMS support

Third parties

  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties code: 3; contact IRT-Global.Helpdesk@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Independent Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Anaphylaxis and Cardiovascular Adjudication Committee","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Laboratory services (sponsorDuties code: 4); contact ctasubmissions@labcorp.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"CDMS support (sponsorDuties code: 7)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Lutikizumab
Active Substance
LUTIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Authorised
Investigational Product Name
USP/Ph. Eur.ABBV-323
Active Substance
RAVAGALIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION/INFUSION
Route
Subcutaneous injection/infusion
Authorisation Status
Authorised
Investigational Product Name
Universal Placebo (Lutikizumab, Ravagalimab)
Modality
Other
Combination Treatment
Yes

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