A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

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)

Overview

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.

Interventions

• Drug Zasocitinib
  Zasocitinib over-encapsulated tablets.
• Drug Active Comparator
  Active comparator capsule.
• Drug Placebo
  Zasocitinib or active comparator matching placebo.

Primary outcome measures

• Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: At Week 16]

Secondary outcome measures (12)

• Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: At Week 16]
• 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 [Time frame: Baseline, at Week 16]
• Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: At Week 16]
• Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: Baseline, at Week 16]
• Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: At Week 16]
• 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 [Time frame: Baseline, at Week 16]
• Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo [Time frame: Baseline, at Week 16]
• Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator [Time frame: At Week 16]
• Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A compared to Active Comparator [Time frame: Baseline, at Week 16]
• 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 [Time frame: Baseline, at Week 16]
• Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Time frame: Baseline, at Week 16]
• 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 [Time frame: Baseline, at Week 16]

Eligibility criteria

Inclusion criteria

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 a diagnosis of PsA.
• The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
• 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) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
• Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).

Exclusion criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 53 centers

• AARR- Chandler AZ — Chandler
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• First OC Dermatology Research Inc. — Fountain Valley
• Purushotham & Akther Kotha MD — La Mesa
• Triwest Research Associates LLC — La Mesa
• The Cohen Medical Centers — Thousand Oaks
• … and 45 more centers

Poland · 27 centers

Center list to be confirmed — check the primary protocol.

Mexico · 10 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 9 centers

• Diagnostic Consultative Centre - Focus-5 - LZIP EOOD — Sofia
• Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia — Sofia
• Centre of Rheumatology St. Irina — Sofia
• Medical Center Medconsult Pleven OOD — Pleven
• AES Partner Site -Plovdiv — Plovdiv
• Medical Center Artmed OOD | Plovdiv, Bulgaria — Plovdiv
• Diagnostic- Consultative Center- 1- Ruse EOOD — Rousse
• Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria — Stara Zagora
• … and 1 more center

Czechia · 9 centers

• Revmatologie s.r.o. | Brno, Czech Republic — Brno
• L.K.N. Arthrocentrum, s.r.o. - Revmatologicka — Hlučín
• Clintrial s.r.o. | Prague, Czech Republic — Prague
• … and 6 more centers

Italy · 9 centers

Center list to be confirmed — check the primary protocol.

Germany · 8 centers

Center list to be confirmed — check the primary protocol.

Hungary · 6 centers

Center list to be confirmed — check the primary protocol.

Israel · 6 centers

Center list to be confirmed — check the primary protocol.

Portugal · 6 centers

Center list to be confirmed — check the primary protocol.

Spain · 6 centers

Center list to be confirmed — check the primary protocol.

Belgium · 5 centers

• Université Libre de Bruxelles — Anderlecht
• University Hospital Ghent — Ghent
• ReumaClinic Genk — Genk
• St Pierre Brussels — Brussels
• Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman — Liège

Chile · 5 centers

• El Centro de Estudios Reumatologicos (CER) — Providencia
• Clinica Dermacross S.A. — Santiago
• Centro de Estudios Clinicos — Santiago
• CTR Estudios — Santiago
• Centro Internacional de Estudios Clínicos — Santiago

Croatia · 5 centers

• Medicinski Centar Kuna and Peric — Zagreb
• Clinical Hospital Centre Osijek — Osijek
• Clinical Hospital Center Rijeka — Rijeka
• University Hospital Centre Split — Split
• General Hospital Zadar — Zadar

Estonia · 5 centers

Center list to be confirmed — check the primary protocol.

New Zealand · 5 centers

Center list to be confirmed — check the primary protocol.

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

Latvia · 2 centers

Center list to be confirmed — check the primary protocol.

Puerto Rico · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06671483 · TAK-279-PsA-3001 · 2024-513111-27-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗