Clinical trial • Phase II • Musculoskeletal

TULISOKIBART for Psoriatic arthritis

Phase II trial of TULISOKIBART for Psoriatic arthritis. Randomised, placebo to mk-7240 (placebo comparator; no dose or schedule specified)-controlled.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Psoriatic arthritis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
08-01-2026
First CTIS Authorization Date
30-04-2026

Trial design

Randomised, placebo to mk-7240 (placebo comparator; no dose or schedule specified)-controlled Phase II trial in Spain, Poland, Germany.

Randomised
Yes
Comparator
Placebo to MK-7240 (placebo comparator; no dose or schedule specified)
Target Sample Size
97
Trial Duration For Participant
112

Eligibility

Recruits 97 No vulnerable populations selected; no consent or assent handling described..

Vulnerable Population
No vulnerable populations selected; no consent or assent handling described.

Inclusion criteria

  • {"criterion_text":"- Has a clinical diagnosis of psoriatic arthritis (PsA), with symptom onset ≥6 months before Screening."}
  • {"criterion_text":"- Has active disease, defined as ≥3 tender joints and ≥3 swollen joints."}
  • {"criterion_text":"- Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis."}
  • {"criterion_text":"- Has had inadequate response or intolerance to certain disease-modifying antirheumatic drugs (DMARDs)."}
  • {"criterion_text":"- If on treatment with any protocol-specified drugs during the study, meets drug stable duration requirements, as applicable."}

Exclusion criteria

  • {"criterion_text":"- Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may interfere with the assessment of PsA."}
  • {"criterion_text":"- Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study."}
  • {"criterion_text":"- Has had joint surgery at joints to be assessed in the study ≤8 weeks before randomization."}
  • {"criterion_text":"- Has had inadequate response, intolerance, or treatment with a targeted synthetic DMARD for ≥8 weeks."}
  • {"criterion_text":"- Has received an intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath injection <8 weeks before randomization."}
  • {"criterion_text":"- Has a skin condition diagnosis, other than psoriasis that may interfere with the assessment of psoriasis."}
  • {"criterion_text":"- Has a diagnosis of fibromyalgia that has been active within the 12 months before randomization or would have the potential to interfere with efficacy assessments."}
  • {"criterion_text":"- Has a transplanted organ and requires continued systemic immunosuppression."}
  • {"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 had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments."}
  • {"criterion_text":"- Has a known infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus."}
  • {"criterion_text":"- Has any active infection."}
  • {"criterion_text":"- Has active tuberculosis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16","definition_or_measurement_approach":"Proportion of participants achieving ACR20 response at Week 16."}

Secondary endpoints

  • {"endpoint_text":"- Number of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16","definition_or_measurement_approach":"Proportion of participants achieving ACR50 response at Week 16."}
  • {"endpoint_text":"- Number of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16","definition_or_measurement_approach":"Proportion of participants achieving ACR70 response at Week 16."}
  • {"endpoint_text":"- Mean Change from Baseline in the Health Assessment of Questionnaire Disability Index (HAQ-DI) at Week 16","definition_or_measurement_approach":"Mean change from baseline in HAQ-DI score at Week 16."}
  • {"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 (safety endpoint)."}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention because of an adverse event."}

Recruitment

Planned Sample Size
97
Recruitment Window Months
40
Consent Approach
Participant informed consent is required using main consent forms; country-specific ICFs are available (Spain: Spanish; Poland: Polish; Germany: German; English-language consent documents also listed). No assent or minor-specific consent procedures are described in the available records.

Geography

Total Number Of Sites
16
Total Number Of Participants
49

Spain

Earliest CTIS Part Ii Submission Date
22-02-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
71
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Futuremeds Spain S.L.
Department Name
Dept. of Rheumatology
Contact Person Name
Jacqueline Uson
Contact Person Email
Jacqueline.uson@futuremeds.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Dept. of Rheumatology
Contact Person Name
Alba Erra Duran
Contact Person Email
alba.erra@vallhebron.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Dept. of Rheumatology
Contact Person Name
Jose Andrés Román Ivorra
Contact Person Email
roman_jan@gva.es
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

Poland

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
28
Number Of Sites
7
Number Of Participants
22

Sites

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
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
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. (Warsaw)
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Małgorzata Socik-Pojawa
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Torun)
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Sławomir Jeka
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz)
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Iwona Dankiewicz-Fares
Contact Person Email
iwonafares@wp.pl
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

Germany

Earliest CTIS Part Ii Submission Date
21-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
9
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Rheumatologische Schwerpunktpraxis
Department Name
Innere Medizin und Rheumatologie
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de
Site Name
Rheumapraxis Heidelberg
Department Name
Rheumapraxis Heidelberg
Contact Person Name
Bernhard Heilig
Site Name
Rheuma-Research Lausitz Zentrum für klinische Studien
Department Name
Zentrum für klinische Studien
Contact Person Name
Mario Sutowicz
Contact Person Email
sutowicz@gmx.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum Ruhrgebiet
Contact Person Name
Ioana Andreica
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Rheumatologie
Contact Person Name
Hildrun Haibel
Contact Person Email
hildrun.haibel@charite.de

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Q2 Solutions LLC
Responsibilities
Antibody testing
Name
Clario
Name
Signant Health Global LLC
Name
ICON PLC
Name
Syneos Health Clinique Inc.
Name
Sampled (formerly Infinity Biologix)
Responsibilities
Genetic Analysis

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Antibody testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"ICON PLC","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Sampled (formerly Infinity Biologix)","duties_or_roles":"Genetic Analysis","organisation_type":"Industry"}

Investigational products

Investigational Product Name
tulisokibart
Active Substance
TULISOKIBART
Modality
Peptide/protein/enzyme
Routes Of Administration
Solution for injection in pre-filled injector (autoinjector)
Route
Pre-filled autoinjector (injection)
Authorisation Status
Investigational (MIA number IMP11011/00003)
Investigational Product Name
Placebo to MK-7240
Modality
Other

Related trials

Other published trials that may interest you.