Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion 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:

  1. 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:

  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).

You CAN'T join if...

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).

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