The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo
in biologic-experienced 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 Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis

Arthritis, Psoriatic

Psoriatic Arthritis

Rheumatology

Immune system conditions

Placebo

Icotrokinra

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced 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 [arthritis, 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 (arthritis, 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 (arthritis, 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 was computed as the sum of domain scores and divided by
the number of domains answered. Total possible score range 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 was an average of the
individual question scores, which were scaled 0 to 100 (100=highest level of
functioning). Score from physical function, role physical, bodily pain, and general
health domains were averaged to calculate PCS. Total score range for PCS was 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).

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
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. Presence and
severity of dactylitis will be assessed in both hand and feet using a scoring system from
0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe
dactylitis). The result for each digit are summed to produce a final dactylitis score
with a range from 0 to 60. Higher score indicates greater severity.

Dactylitis is characterized by swelling of the entire finger or toe. Presence and
severity of dactylitis will be assessed in both hand and feet using a scoring system from
0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe
dactylitis). The result for each digit are summed to produce a final dactylitis score
with a range from 0 to 60. Change from baseline in dactylitis score measure the change in
dactylitis, where a negative change indicates an improvement and a positive change
indicates a worsening.

MDA criteria are a composite of 7 outcome measures used in PsA. Participants are
classified as achieving MDA if they fulfill at least 5 out of the 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 percent (%); 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 have not discontinued will
be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra
Dose 1.

Participants will receive icotrokinra Dose 2. Participants who have not discontinued will
be eligible to enter a LTE and 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 at Week 16. Participants who have not discontinued will be
eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.

AARA Clinical Research

Arthritis and Rheumatism Associates ARA Jonesboro

Clinical Research of West Florida

Omega Research Consultants

Suncoast Clinical Research

Integral Rheumatology And Immunology Specialists

Clinic of Robert Hozman

Klein And Associates M D P A

DM Clinical Research

St Paul Rheumatology PA

Albuquerque Rehabilitation and Rheumatology

Joint and Muscle Research Institute

Rheumatology Associates of Oklahoma

Altoona Center For Clinical Research

Arthritis and Rheumatology Research Institute

UT Southwestern

Naiara Alvarez MD Integrative Rheumatology of South TX

AARA Clinical Research Lone Star Arthritis and Rheumatology

Velocity Clinical Research

Instituto Medico De Alta Complejidad (IMAC)

ARCIS Salud SRL Aprillus asistencia e investigacion

Hospital Militar Central Cir. My. Dr. Cosme Argerich

Arsema

Centro Medico Privado de Reumatologia Tucuman

MR Medicina Reumatologica

Ipswich Hospital

Rheumatology Research Unit

Queen Elizabeth Hospital

Royal North Shore Hospital

Royal Darwin Hospital

Universidade Federal de Minas Gerais UFMG Faculdade de Medicina

LMK Servicos Medicos S S

BR TRIALS Ensaios Clinicos e Consultoria Ltda

Hospital Das Clinicas Da Faculdade De Medicina Da USP

UMHAT Kaspela

Multiprofile Hospital for Active Treatment Plovdiv

Diagnostic Consulting Center I Sliven

Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

Diagnostic-Consultative Center (DCC) Aleksandrovska

UMHAT St. Ivan Rilski

ASIMP Rheumatology Centre St Irina EOOD

Eastern Regional Health Authority St Clares Mercy Hospital

The Waterside Clinic

Womens College Hospital

Alliance Clinical Trials

Dr Sabeen Anwar Medicine Professional Corporation

Centre de Recherche Musculo Squelettique

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

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

The First Hospital of Jiaxing

Jinhua municipal central hospital

Linyi City People 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

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

Revmacentrum MUDr Mostera s r o

Revmatologie s r o

RHEUMA s r o

L K N Arthrocentrum

CCR Ostrava S R O

MUDr Rosypalova s r o

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

Charite - Campus Mitte

ISA - Interdisciplinary Study Association GmbH

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Hamburger Rheuma Forschungszentrum II

Rheumazentrum Ruhrgebiet

Praxis Dr. med. Beate Schwarz - Germany

Rheumaforschung - Studienambulanz Dr. Wassenberg

Universitatsklinikum Tubingen

Prince of Wales Hospital

Queen Mary Hospital

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Revita Kft

Maeshima Rheumatology Clinic

Hospital Sultan Ismail

Hosp. Virgen Del Rocio

Glasgow Royal Infirmary

Uno Medical Trials Ltd.

Apollo Hospitals

SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

St. Luke's International Hospital

Tohoku University Hospital

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Pratia MCM Krakow

NZOZ Lecznica MAK MED S C

Ecomed Research SRL

Western General Hospital

Osaka Metropolitan University Hospital

Royal Free London NHS Foundation Trust

Hospital Maisonneuve-Rosemont

Kaohsiung Chang Gung Memorial Hospital

Marengo Cims Hospital

Hospital Kuala Lumpur

Fondazione Policlinico Universitario A Gemelli IRCCS

Hosp. Univ. Infanta Leonor

MAV Korhaz es Rendelointezet

Haywood Hospital

RM Pharma Specialists

Rajavithi Hospital

Universita Degli Studi di Roma Tor Vergata

Dokkyo Medical University Hospital

Hospital Universitario Dr Jose Eleuterio Gonzalez

Hosp. Clinico Univ. de Santiago

Malopolskie Badania Kliniczne Sp z o o

A.O. Universitaria Ospedali Riuniti di Ancona

Ospedale S. Maria Della Misericordia

MICS Centrum Medyczne Torun

MC Ekselsior

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

IRCCS Policlinico San Matteo

Qualiclinic Kft

Hospital Sultanah Bahiyah

Hosp Reina Sofia

Forth Valley Royal Hospital

A O Universitaria Senese Ospedale Santa Maria alle Scotte

Osteo-Medic s.c A. Racewicz, J Supronik

Ambulatorium sp. z o.o.

Indraprastha Apollo Hospital

University of Szeged

Hosp. Univ. de Bellvitge

Hereford County Hospital

Taipei Veterans General Hospital

Torbay Hospital-Devon

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures