A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 29, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called icotrokinra to see how well it works and how safe it is for people with active psoriatic arthritis (PsA) who have already tried other biologic treatments. The goal is to find out if icotrokinra can help reduce the signs and symptoms of PsA, such as swollen and tender joints.
To participate in this study, you need to have been diagnosed with psoriatic arthritis for at least three months and have previously received at least one biologic treatment for it or for psoriasis. You should also have signs of active PsA, like swollen joints and signs of skin psoriasis. During the trial, participants will receive either the medication or a placebo (a dummy treatment) to compare the effects. It’s important to note that there are some health conditions that might prevent someone from participating, so discussing your medical history with the study team will be essential. If you're interested, this trial is currently recruiting participants of all genders between the ages of 65 and 74.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented
- • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
- • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory.
- • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- • Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
- • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
- Exclusion Criteria:
- • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- • Currently has a malignancy or has a history of malignancy within 5 years prior to screening
- • Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
- • Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease
- • Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, , Thailand
Hong Kong, , Hong Kong
Vejle, , Denmark
Duncansville, Pennsylvania, United States
Clearwater, Florida, United States
New Port Richey, Florida, United States
Pavia, , Italy
Taipei, , Taiwan
Milano, , Italy
Edinburgh, , United Kingdom
Wolverhampton, , United Kingdom
Rozzano, , Italy
Bangkok, , Thailand
Shanghai, , China
Tubingen, , Germany
Frederiksberg, , Denmark
Herne, , Germany
St Leonards, , Australia
Bangkok, , Thailand
Santiago De Compostela, , Spain
Tampa, Florida, United States
Aarhus N, , Denmark
Taipei, , Taiwan
Songkhla, , Thailand
Udine, , Italy
Esbjerg, , Denmark
Budapest, , Hungary
Beijing, , China
Basingstoke, , United Kingdom
Kaohsiung, , Taiwan
Larbert, , United Kingdom
Tainan, , Taiwan
Szeged, , Hungary
Tomball, Texas, United States
Nantong, , China
Charlotte, North Carolina, United States
Chengdu, , China
Madrid, , Spain
Nanchang, Jiangxi, China
Dresden, , Germany
Barnet, , United Kingdom
Plantation, Florida, United States
Gdynia, , Poland
Chongqing, , China
Debary, Florida, United States
Hereford, , United Kingdom
Santander, , Spain
New Delhi, , India
Changchun, , China
Ipswich, , Australia
Changsha, , China
Guiyang, , China
Sevilla, , Spain
Wroclaw, , Poland
Berlin, , Germany
Szolnok, , Hungary
Jiaxing, , China
Bydgoszcz, , Poland
Sevilla, , Spain
Skokie, Illinois, United States
Maroochydore, , Australia
Wenzhou, , China
Langenau, , Germany
Saraburi, , Thailand
Hong Kong, , Hong Kong
Sofia, , Bulgaria
Sevilla, , Spain
Noida, , India
Eagan, Minnesota, United States
Sofia, , Bulgaria
Bhubaneswar, , India
Torquay, , United Kingdom
Hamburg, , Germany
Veszprem, , Hungary
Guangzhou, , China
Hyogo, , Japan
Plovdiv, , Bulgaria
Ancona, , Italy
Allen, Texas, United States
Warszawa, , Poland
Oklahoma City, Oklahoma, United States
Warszawa, , Poland
Mysuru, , India
Staffordshire, , United Kingdom
Budapest, , Hungary
Warszawa, , Poland
Shanghai, , China
Nanchang, , China
Elblag, , Poland
Torun, , Poland
Suzhou, , China
Pingxiang, , China
Sofia, , Bulgaria
Waterloo, Ontario, Canada
Krakow, , Poland
Surat, , India
Gyula, , Hungary
Elblag, , Poland
Herning, , Denmark
Bialystok, , Poland
Bialystok, , Poland
Tsu, , Japan
Orillia, Ontario, Canada
Roma, , Italy
Lodz, , Poland
Hagerstown, Maryland, United States
Sofia, , Bulgaria
Siena, , Italy
Buenos Aires, , Argentina
Lodz, , Poland
Chengdu, , China
Nadarzyn, , Poland
Hlucin, , Czechia
Uherske Hradiste, , Czechia
Zlin, , Czechia
Osaka, , Japan
Krakow, , Poland
Brno, , Czechia
Elblag, , Poland
Krakow, , Poland
Tokyo, , Japan
Bialystok, , Poland
Krakow, , Poland
Buenos Aires, , Argentina
Taiyuan, , China
Kecskemet, , Hungary
Sendai, , Japan
Krakow, , Poland
Cordoba, , Spain
Budapest, , Hungary
Warszawa, , Poland
Napoli, , Italy
Sasebo, , Japan
Tiwi, , Australia
Krakow, , Poland
A Coruna, , Spain
Nagoya City, , Japan
Chuo Ku, , Japan
St Johns, Newfoundland And Labrador, Canada
Malaga, , Spain
Shimotsuga Gun, , Japan
Hirakata, , Japan
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Windsor, Ontario, Canada
South Woodville, , Australia
Bydgoszcz, , Poland
Oita, , Japan
Irving, Texas, United States
Breclav, , Czechia
Hsin Chu, , Taiwan
Culiacan, , Mexico
Jonesboro, Arkansas, United States
Trois Rivieres, Quebec, Canada
Jinhua, , China
Linyi City, , China
Sanuki, , Japan
Svendborg, , Denmark
Mesa, Arizona, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad De Buenos Aires, , Argentina
Ciudad De San Miguel De Tucuman, , Argentina
Hangzhou, , China
Shenzhen, , China
Ratingen, , Germany
Bialystok, , Poland
Porto Alegre, , Brazil
Glendale, Arizona, United States
Brookline, Massachusetts, United States
Albuquerque, New Mexico, United States
Sliven, , Bulgaria
Beijing, , China
Xian City, , China
Brno, , Czechia
Ostrava, , Czechia
Ostrava, , Czechia
Praha, , Czechia
Budapest, , Hungary
Debrecen, , Hungary
Gdynia, , Poland
Lublin, , Poland
Torun, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Craiova, , Romania
Iasi, , Romania
Ramnicu Valcea, , Romania
Christchurch, , United Kingdom
San Fernando, , Argentina
Bialystok, , Poland
Harlingen, Texas, United States
Kaposvar, , Hungary
Hubballi, , India
Kolkata, , India
Catania, , Italy
Ciudad De Mexico, , Mexico
Guadalajara, , Mexico
Mexicali, , Mexico
Wrexham, , United Kingdom
Nadarzyn, , Poland
Belo Horizonte, , Brazil
Toronto, Ontario, Canada
Bialystok, , Poland
Krakow, , Poland
Krakow, , Poland
Wroclaw, , Poland
L Hospitalet De Llobregat, , Spain
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported