Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends 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, Counterfeit Drugs, 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 5350207 California 5332921 92708 United States
  • Biosolutions Research Center | La Mesa, CA not yet accepting patients
    Poway 5384690 California 5332921 92064 United States
  • Purushotham & Akther Kotha MD accepting new patients
    La Mesa 5363990 California 5332921 91942 United States
  • Triwest Research Associates LLC accepting new patients
    La Mesa 5363990 California 5332921 91942 United States
  • Foothill Arthritis Clinic accepting new patients
    Tujunga 5403767 California 5332921 91042 United States
  • Medvin Clinical Research accepting new patients
    Whittier 5409059 California 5332921 90602-1005 United States
  • VA Northern California Health Care System - NAVREF - PPDS not yet accepting patients
    Mather 5371065 California 5332921 95655-4200 United States
  • The Cohen Medical Centers accepting new patients
    Thousand Oaks 5402405 California 5332921 91360-3967 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT06671483
Phase
Phase 3 Arthritis Research Study
Study Type
Interventional
Participants
Expecting 1088 study participants
Last Updated