A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
a study on Arthritis
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedcompletion around
Description
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 who have not previously been treated with biologic disease-modifying antirheumatic drugs.
The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
Keywords
Psoriatic Arthritis, Drug Therapy, Latitude Research Program, Latitude PsA, Latitude PsA-3001, Arthritis, Zasocitinib, Active Comparator
Eligibility
You can join if…
Open to people ages 18 years and up
Age:
The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is >=19 years of age.
Disease Characteristics:
- The participant has had signs and symptoms consistent with PsA for at least 3 months.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- 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.
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:
- The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
You CAN'T join if...
PsA and PsO:
- 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.
- 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).
Locations
- First OC Dermatology Research Inc.
accepting new patients
Fountain Valley California 92708 United States - Amicis Research Center | Northridge, CA
not yet accepting patients
Northridge California 91324 United States - Biosolutions Research Center | La Mesa, CA
not yet accepting patients
Poway California 92064 United States - Purushotham & Akther Kotha MD
not yet accepting patients
La Mesa California 91942 United States - Triwest Research Associates LLC
not yet accepting patients
La Mesa California 91942 United States - Foothill Arthritis Clinic
not yet accepting patients
Tujunga California 91042 United States - Amicus Arthritis & Osteoporosis Center (AAOC)
not yet accepting patients
Whittier California 90602-1005 United States - VA Northern California Health Care System | Sacramento VA Medical Center
not yet accepting patients
Mather California 95655-4200 United States - The Cohen Medical Centers
not yet accepting patients
Thousand Oaks California 91360-3967 United States - West Texas Clinical Research
accepting new patients
Lubbock Texas 79424 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Takeda
- Links
- More about this study
- ID
- NCT06671483
- Phase
- Phase 3 Arthritis Research Study
- Study Type
- Interventional
- Participants
- Expecting 1088 study participants
- Last Updated