Clinical trial • Phase II • Immunology

TULISOKIBART for Rheumatoid arthritis

Phase II trial of TULISOKIBART 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
15-07-2025
First CTIS Authorization Date
27-10-2025

Trial design

Randomised, placebo to mk-7240 (tulisokibart) (placebo comparator arm specified; dose and schedule not specified in provided records)-controlled Phase II trial in Germany, Poland, Spain.

Randomised
Yes
Comparator
Placebo to MK-7240 (tulisokibart) (placebo comparator arm specified; dose and schedule not specified in provided records)
Target Sample Size
141

Eligibility

Recruits 141 No vulnerable population selected (isVulnerablePopulationSelected:false). Subject information and informed consent forms are provided (Main consent documents listed for Germany, Poland, Spain) and optional associated-person and optional extension forms are available as indicated in application documents..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected:false). Subject information and informed consent forms are provided (Main consent documents listed for Germany, Poland, Spain) and optional associated-person and optional extension forms are available as indicated in application documents.

Inclusion criteria

  • {"criterion_text":"- Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria"}
  • {"criterion_text":"- Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)"}
  • {"criterion_text":"- Has current treatment with oral or parenteral methotrexate (MTX) therapy"}
  • {"criterion_text":"- Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS"}

Exclusion criteria

  • {"criterion_text":"- Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA"}
  • {"criterion_text":"- Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization"}
  • {"criterion_text":"- Has any active infection."}
  • {"criterion_text":"- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ACR20 at Week 12 (as stated: assessed by the proportion of participants achieving ACR20 at Week 12)."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ACR50 at Week 12."}
  • {"endpoint_text":"- Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12","definition_or_measurement_approach":"Proportion of participants achieving ACR70 at Week 12."}
  • {"endpoint_text":"- Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)","definition_or_measurement_approach":"Proportion of participants achieving LDA based on DAS28-CRP (timepoint implied Week 12 in objectives)."}
  • {"endpoint_text":"- Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12","definition_or_measurement_approach":"Change from baseline in HAQ-DI score at Week 12."}
  • {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing one or more AEs during the study period."}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention due to an adverse event."}

Recruitment

Registry Or Advocacy Recruitment
True: outreach to advocacy groups is indicated by the document 'K2_Recruitment Doc Dear Advocacy Letter_DEU_DE_SM01'; no specific registries or advocacy group names are provided in the available records.
Digital Remote Recruitment
True: 'K2_Recruitment Doc Digital Ad Pack_DEU_DE_SM01' indicates digital advertising materials (Germany).
Planned Sample Size
141
Recruitment Window Months
17
Consent Approach
Informed consent obtained from participants. Subject information and informed consent forms (L1_ICF_Main consent) are available for Germany, Poland and Spain (documents listed). Optional forms (e.g. optional extension period, optional associated person, optional pregnancy follow-up) are present in the document list for some countries.

Methods

  • K1/K2 Recruitment documents (Germany): K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub (site recruitment and consent procedures documented)
  • K2_Recruitment Doc Patient Flyer_DEU_DE (patient flyer) - channel: printed flyer; country: Germany
  • K2_Recruitment Doc Patient Letter_DEU_DE (patient letter) - channel: letter; country: Germany
  • K2_Recruitment Doc Poster_DEU_DE (poster) - channel: poster; country: Germany
  • K2_Recruitment Doc Digital Ad Pack_DEU_DE (digital advertising materials) - channel: digital ads; country: Germany
  • K2_Recruitment Doc Patient Brochure_DEU_DE (patient brochure) - channel: brochure; country: Germany
  • K1_Recruitment Arrangements and IC Procedure_POL_PL (Poland) and supporting K2 materials (posters, flyers) - channel: printed materials and site outreach; country: Poland
  • K1_Recruitment Arrangements and IC Procedure_ESP_ES (Spain) and supporting K2 materials including Site Physician Referral Letter and General Physician Referral Letter - channel: site referrals and printed materials; country: Spain
  • K2_Recruitment Doc Dear Advocacy Letter_DEU_DE (Dear Advocacy Letter) - channel: outreach to advocacy groups; country: Germany

Geography

Total Number Of Sites
17
Total Number Of Participants
58

Germany

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
121
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Rheuma-Research Lausitz
Contact Person Name
Mario Sutowicz
Contact Person Email
sutowicz@gmx.de
Site Name
Medicover GmbH
Contact Person Name
David Kofler
Contact Person Email
david.kofler@medicover.de
Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
Rheumatologische Schwerpunktpraxis
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de

Poland

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
136
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Joanna Dmowska-Chalaba
Contact Person Email
cwbk@spartanska.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (MICS Centrum Medyczne Warszawa)
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Małgorzata Socik-Pojawa
Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda
Contact Person Name
Dariusz Chudzik
Contact Person Email
dchudzik@reumed.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Contact Person Name
Rafał Wojciechowski
Contact Person Email
reumatologia@biziel.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (MICS Centrum Medyczne Bydgoszcz)
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa
Site Name
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C.
Department Name
Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz
Contact Person Name
Hanna Mastalerz
Contact Person Email
hannamastalerz@wp.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (MICS Centrum Medyczne Toruń)
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Sławomir Jeka
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (additional Warsaw site)
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Małgorzata Socik-Pojawa

Spain

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
148
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Dept. of Rheumatology
Contact Person Name
María García Manrique de Lara
Site Name
Hospital Universitari Vall D Hebron
Department Name
Dept. of Rheumatology
Contact Person Name
María López Lasanta
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Dept. of Rheumatology
Contact Person Name
Eva María Perez Pampin
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Dept. of Rheumatology
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Public Limited Company
Responsibilities
sponsorDuties codes: [4]; contact: SUSTeamClover@iconplc.com
Name
Bioclinica Inc.
Responsibilities
sponsorDuties codes: [7]; contact: melinique.kesely@clario.com
Name
Signant Health LLC
Responsibilities
sponsorDuties codes: [3]; contact: ricardo.rodriguez@signanthealth.com
Name
Parexel International Corp.
Responsibilities
sponsorDuties codes: [15]; EUB services (call center and medical services); contact: +MSDEMU@parexel.com

Third parties

  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"sponsorDuties codes: [4]; contact email: SUSTeamClover@iconplc.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email: melinique.kesely@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties codes: [3]; contact email: ricardo.rodriguez@signanthealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: [15]; duties: EUB services (call center and medical services); contact email: +MSDEMU@parexel.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
tulisokibart
Active Substance
TULISOKIBART
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Investigational
Investigational Product Name
Placebo to MK-7240 (tulisokibart)
Modality
Other
Authorisation Status
Investigational
Combination Treatment
Yes

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