The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo
in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs
and symptoms of PsA.

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

Arthritis, Psoriatic

Psoriatic Arthritis

Rheumatology

Immune system conditions

Placebo

Icotrokinra

Active reference comparator

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis

The ACR 20 responders are participants with an improvement of greater than or equal to
(>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at
least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS),
patient's global assessment of disease activity VAS scale, physician's global assessment
of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In
the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities,
and lower extremities. Each of these areas were assessed separately for the percentage of
the area involved, which translates to a numeric score that ranges from 0 to 6, and for
erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI
produces a numeric score that can range from 0 to 72. A higher score indicates more
severe disease. A PASI 75 response represents participants who achieved at least a 75
percent improvement from baseline in the PASI score.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In
the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities,
and lower extremities. Each of these areas were assessed separately for the percentage of
the area involved, which translates to a numeric score that ranges from 0 to 6, and for
erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI
produces a numeric score that can range from 0 to 72. A higher score indicates more
severe disease. A PASI 90 response represents participants who achieved at least a 90
percent improvement from baseline in the PASI score.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In
the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities,
and lower extremities. Each of these areas were assessed separately for the percentage of
the area involved, which translates to a numeric score that ranges from 0 to 6, and for
erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI
produces a numeric score that can range from 0 to 72. A higher score indicates more
severe disease. A PASI 100 response represents participants who achieved at least a 100
percent improvement from baseline in the PASI score.

Proportion of participants with an IGA psoriasis score of 0 or 1 and >=2 grade
improvement from baseline at week 16 among participants with >=3% BSA and an IGA score of
>=2 at baseline will be reported. The IGA documents the investigator's assessment of the
participant's psoriasis at a given time point. Overall lesions are graded for induration,
erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2
(mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the
average of induration, erythema, and scaling scores. The participant's psoriasis is
assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

The ACR 50 responders are participants with an improvement of >= 50 % from baseline in
both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's
assessment of pain VAS, patient's global assessment of disease activity VAS scale,
physician's global assessment of disease activity VAS scale, health assessment
questionnaire and C-reactive protein).

The ACR 70 responders are participants with an improvement of >= 70 % from baseline in
both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's
assessment of pain VAS, patient's global assessment of disease activity VAS scale,
Physician's global assessment of disease activity VAS scale, health assessment
questionnaire and C-reactive protein).

The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming,
arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in
each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a
task in that area). Overall score is computed as the sum of domain scores and divided by
the number of domains answered. Total possible score range is 0-3 where 0 = least
difficulty and 3 = extreme difficulty.

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing:
physical and social functioning, physical and emotional role limitations, bodily pain,
general health, vitality, mental health. The score for a domain is an average of the
individual question scores, which are scaled 0-100 (100=highest level of functioning).
Score from physical function, role physical, bodily pain, and general health domains are
averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of
physical functioning).

Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed
to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or
absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left
and right, medial femoral condyle, left and right, and achilles tendon insertion, left
and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible
score; 6 sites with tenderness). Resolution is defined as participants have enteritis
(LEI score >0) at baseline and no enthesis (LEO score =0) at the visit (week 16).

Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in
participants with PsA, and evaluates the presence (score of 1) or absence of pain (score
of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial
femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total
scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with
tenderness).

Dactylitis is characterized by swelling of the entire finger or toe. The severity of
dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in
each digit of the hands and feet. The range of total dactylitis scores for a participant
is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as
participants have dactylitis (score >0) at baseline and no dactylitis (score =0) at the
visit (week 16).

Dactylitis is characterized by swelling of the entire finger or toe. The severity of
dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in
each digit of the hands and feet. The range of total dactylitis scores for a participant
is 0-60. Higher score indicates greater degree of tenderness.

MDA criteria are a composite of 7 outcome measures used in PsA. Participants are
classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count
less than or equal to (<=) 1; swollen joint count <= 1; psoriasis activity and severity
index <= 1 or body surface area <= 3; patient pain VAS score of <= 15; patient global
disease activity VAS (arthritis and psoriasis) score of <= 20; health assessment
questionnaire (HAQ) score <= 0.5; and tender entheseal points <= 1.

The FACIT-fatigue is a self-administered, 13-item questionnaire measuring items on
tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses
to all items are rated on a 5-point likert response scale ranging from 0 "not at all" to
4 "very much." The total score ranges from 0 to 52, with higher values indicating less
fatigue.

Participants will receive icotrokinra dose 1. Participants who continue into a long term
extension (LTE) will continue to receive icotrokinra dose 1.

Participants will receive icotrokinra dose 2. Participants who continue into a LTE will
continue to receive icotrokinra dose 2.

Participants will receive placebo matched to icotrokinra and will cross over to receive
icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to
receive icotrokinra dose 1 or dose 2.

Participants will receive active reference drug. Participants who continue into a LTE
will cross-over to receive icotrokinra dose 1 or dose 2.

Arthritis and Rheumatism Associates ARA Jonesboro

Omega Research Consultants

Integral Rheumatology And Immunology Specialists

Clinical Research of West Florida

Willow Rheumatology and Wellness PLLC

Joint and Muscle Research Institute

Altoona Center For Clinical Research

Arthritis and Rheumatology Research Institute

Naiara Alvarez MD Integrative Rheumatology of South TX

Cosultorios Reumatologógicos Pampa

Mindout Research

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Arsema

Centro Medico Privado de Reumatologia Tucuman

Consultora Integral de Salud SRL

MR Medicina Reumatologica

Instituto Medico De Alta Complejidad (IMAC)

Ipswich Hospital

Rheumatology Research Unit

BJC Health

Queen Elizabeth Hospital

Royal Darwin Hospital

MC Medtech Services Ltd

Exacta Medica

Medical Center Artmed

Medical Center Teodora

Peking University Third Hospital

Beijing Tong Ren Hospital Capital Medical University

The First Bethune Hospital of Jilin University

Xiangya Hospital Central South University

West China Hospital Sichuan University

Sichuan Provincial Peoples Hospital

The First Affiliated Hospital of Chongqing Medical University

Nanfang Hospital of Southern Medical Hospital

The Affiliated Hospital of Guizhou Medical University

Linyi City People Hospital

Jiangxi Provincial Peoples Hospital

The Second Affiliated Hospital of Nanchang University

Affiliated Hospital of Nantong University

Pingxiang People's Hospital

Huashan Hospital Fudan University

Shanghai skin disease hospital

Shenzhen People s Hospital

The Third Hospital of Hebei Medical University

Second Affiliated Hospital of Soochow University

Shanxi Bethune Hospital

The First Affiliated Hospital of Wenzhou Medical University

The Second Affiliated Hospital of Xi'an Jiaotong University

Affiliated Hospital of Jiangsu University

Revmatologie s r o

Revmacentrum MUDr Mostera s r o

RHEUMA s r o

Revmatologicka ambulance

L K N Arthrocentrum

CCR Ostrava S R O

MUDr Rosypalova s r o

Revmatologicky ustav

Thomayerova nemocnice

FN Motol

Medical Plus S R O

PV Medical S R O

Aarhus University Hospital

Sydvestjysk Sygehus

Frederiksberg Hospital

Regionshospitalet Godstrup

Svendborg Hospital Odense University Hospital

Vejle Sygehus

Fachklinik Bad Bentheim

Charite Universitaetsmedizin Berlin

ISA - Interdisciplinary Study Association GmbH

Universitatsklinikum Carl Gustav Carus Dresden

Hamburger Rheuma Forschungszentrum II

Rheumazentrum Ruhrgebiet

Studienzentrum Dr Schwarz Germany

Johannes Wesling Klinikum Minden

Universitatsklinikum Tubingen

Prince of Wales Hospital

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Revita Kft

Obudai Egeszsegugyi Centrum Kft

Qualiclinic Kft

Synexus Magyarorszag Kft

Uno Medical Trials Ltd.

University of Debrecen

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

University of Szeged

MAV Korhaz es Rendelointezet

Vital Medical Center Orvosi es Fogaszati Kozpont

Apollo Hospitals

Apollo Multispeciality Hospital Ltd

Kokilaben Dhirubhai Ambani Hsp And Med Research Inst

JSS Hospital

Indraprastha Apollo Hospital

Fortis Hospital

SIDS Hospital & Research Centre

Fukuoka University Hospital

Teikyo University Hospital

Kagawa University Hospital

MICS Centrum Medyczne Warszawa

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osteo Medic S C Artur Racewicz Jerzy Supronik

Hosp. Univ. 12 de Octubre

Centrum Medyczne All Med

Revimex Pro s r o

All India Institute of Medical Sciences

Sasebo Chuo Hospital

Ambulatorium sp. z o.o.

Centrum Kliniczno Badawcze

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

Trials at a glance

Trials at a glance

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

Outcome measures

Primary outcome measures

Secondary outcome measures