Clinical trial NCT06671496: A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
Official title: A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Drug Therapy
Latitude Research Program
Latitude PsA
Latitude PsA-3002
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).

The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.

The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.


Eligibility criteria: Inclusion Criteria:

Age:

1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).

   Disease Characteristics:
2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
4. The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
5. The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

   Medications for PsA:
6. The participant has had at least one of the following:

   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
   3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

Exclusion Criteria:

PsA and PsO:

1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: At Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: At Week 16
measure: Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: At Week 16
measure: Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: At Week 16
measure: Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 8 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 8
measure: Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo
timeFrame: Baseline, at Week 16
measure: Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo
timeFrame: Baseline, at Week 16
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
state: Arizona
city: Covina
country: United States
facility: Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
state: California
city: Hialeah
country: United States
facility: Direct Helpers Medical Center
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development | Plantation, FL
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Medical Group
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group PC
state: Georgia
city: Skokie
country: United States
facility: Clinic of Robert Hozman
state: Illinois
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lansing
country: United States
facility: Advanced Rheumatology PC | Lansing, MI
state: Michigan
city: Kansas City
country: United States
facility: AARR- Kansas City Physician Partners
state: Missouri
city: Charlotte
country: United States
facility: DJL Clinical Research | Charlotte, NC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research | Ducansville, PA
state: Pennsylvania
city: Fort Worth
country: United States
facility: AARR- Lone Star Arthritis & Rheumatology Associates
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic | Hassan
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston - The Woodlands
state: Texas
city: Seattle
country: United States
facility: Swedish Rheumatology Research
state: Washington
city: LaPlata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Clinica Regional del Sud S.A.
state: Cordoba
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Reumatologicas
state: Tucuman
city: San Miguel De Tucumán
country: Argentina
facility: CIMER
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudo Jose Maria Ramos Mejia
city: Buenos Aires
country: Argentina
facility: APRILLUS Asistencia e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina
city: San Juan
country: Argentina
facility: CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sippy Downs
country: Australia
facility: Sunshine Coast University Private Hospital | Clinical Trials
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital | Rheumatology Department
state: South Australia
city: Palmyra Dc
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Victoria Park
country: Australia
facility: Colin Bayliss Research and Teaching Unit
state: Western Australia
city: Juiz De Fora
country: Brazil
facility: CMIP-Centro Mineiro de Pesquisa Ltda
state: Minas Gerais
city: Uberlandia
country: Brazil
facility: Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED - Educacao em Saude SS Ltda
state: PR
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos Sociedade Simples
state: RS
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigacao Clinica
city: Niagara Falls
country: Canada
facility: Niagara Rheumatology Research Centre | Ontario, Canada
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Women's College Hospital (WCH)
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases
state: Ontario
city: Quebec
country: Canada
facility: G.R.M.O. Inc.
city: Bengbu
country: China
facility: The First Affiliated Hospital Of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guandong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
state: Hubei
city: Zhuzhou Shi
country: China
facility: Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
state: Hunan Sheng
city: Baotou Shi
country: China
facility: Inner Mongolia University of Science and Technology (IMUST) - Baotou Medical College (BMC) - First Affiliated Hospital
state: Inner Mongolia Autonomous Region
city: Hangzhou
country: China
facility: The First Peoples Hospital - Changzhou (The Third Affiliated Hospital of Suzhou University)
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Jiujiang Shi
country: China
facility: Jiujiang No.1 People's Hospital
state: Jiangxi Sheng
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Pingxiang
city: Pudong New District
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan Shi
country: China
facility: Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The 2nd Hospital of Xi'An Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Linyi Shi
country: China
facility: Linyi People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University)
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
city: Wenzhou Shi
country: China
facility: Wenzhou Medical University (WMU) - The First Affiliated Hospital
city: Caluire-et-Cuire
country: France
facility: Clinique de l'Infirmerie Protestante
state: Auvergne-Rhône-Alpes
city: Toulouse cedex 9
country: France
facility: CHU Toulouse
state: Haute Garonne
city: Tours cedex 9
country: France
facility: CHRU de Tours
state: Indre Et Loire
city: Reims
country: France
facility: CHU de Reims
state: Marne
city: St Etienne
country: France
facility: Hopital Nord
city: Magdeburg
country: Germany
facility: Private Practice - Dr. Maren Sieburg
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association
city: Hamburg
country: Germany
facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Minami-ku, Nagoya-shi
country: Japan
facility: Kojunkai Social Medical Corporation Daido Clinic
state: Aichi
city: Nagoya-City
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Fukuoka-Shi
country: Japan
facility: Fukuoka University Hospital
state: Hukuoka
city: Ono-shi
country: Japan
facility: Kita-Harima Medical Center
state: Hyogo
city: Tsu, Mie
country: Japan
facility: Mie University Hospital
state: Mie-Ken
city: Sendai-shi
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
state: Miyagi-Ken
city: Sendai City
country: Japan
facility: Tohoku Medical and Pharmaceutical University Hospital
state: Miyagi
city: Sasebo-shi
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Nishi Ward
country: Japan
facility: Nippon Life Hospital
state: Osaka
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo-To
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Wroclaw
country: Poland
facility: Reum-Medica s.c. Bozena Kowalewska, Marek Zawadzki
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
state: Kujawsko Pomorskie
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED Badania Kliniczne | Krakow, Poland
state: Malopolskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze | Elblag, Poland
state: Warminsko-Mazurskie
city: Poznan
country: Poland
facility: Clinical Research Center Sp z o o Medic-R Sp K
state: Wielkopolska
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmańska Piotr Leszczyński
state: Wielkopolska
city: Warsaw
country: Poland
facility: Klinika Reuma Park
state: Wybierz Województwo
city: Czestochowa
country: Poland
facility: Pratia | Centrum Medyczne Pratia Czestochowa - Czestochowa, Poland
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed
city: Wrocław
country: Poland
facility: dermMedica Sp. z o.o.
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla | Rheumatology Department
state: Cantabria
city: Alcobendas
country: Spain
facility: Accellacare Alcobendas
state: Madrid
city: Vitoria
country: Spain
facility: Hospital Universitario Araba - Sede Hospital Txagorritxu
state: Pais Vasco
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Quirónsalud Sagrado Corazón
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: Coventry
country: United Kingdom
facility: Coventry and Warwickshire Partnership NHS Trust
state: West Midlands
city: Bradford
country: United Kingdom
facility: St Luke's Hospital - UK
state: West Yorkshire
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Stoke-on-Trent
country: United Kingdom
facility: Haywood Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: