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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06671483




Registration number
NCT06671483
Ethics application status
Date submitted
31/10/2024
Date registered
4/11/2024

Titles & IDs
Public title
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Scientific 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)
Secondary ID [1] 0 0
2024-513111-27-00
Secondary ID [2] 0 0
TAK-279-PsA-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zasocitinib
Treatment: Drugs - Active Comparator
Treatment: Drugs - Placebo

Experimental: Zasocitinib Dose A - Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

Experimental: Zasocitinib Dose B - Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

Active comparator: Active Comparator Dose C - Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.

Experimental: Placebo + Zasoctinib - Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.


Treatment: Drugs: Zasocitinib
Zasocitinib over-encapsulated tablets.

Treatment: Drugs: Active Comparator
Active comparator capsule.

Treatment: Drugs: Placebo
Zasocitinib or active comparator matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [1] 0 0
At Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline, at Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [3] 0 0
At Week 16
Secondary outcome [4] 0 0
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [4] 0 0
Baseline, at Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [5] 0 0
At Week 16
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline, at Week 16
Secondary outcome [7] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo
Timepoint [7] 0 0
Baseline, at Week 16
Secondary outcome [8] 0 0
Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [8] 0 0
At Week 16
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, at Week 16
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline, at Week 16
Secondary outcome [11] 0 0
Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [11] 0 0
Baseline, at Week 16
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline, at Week 16
Secondary outcome [13] 0 0
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 8 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [13] 0 0
Baseline, at Week 8
Secondary outcome [14] 0 0
Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [14] 0 0
Baseline, at Week 16
Secondary outcome [15] 0 0
Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [15] 0 0
Baseline, at Week 16
Secondary outcome [16] 0 0
Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [16] 0 0
Baseline, at Week 16
Secondary outcome [17] 0 0
Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [17] 0 0
Baseline, at Week 16
Secondary outcome [18] 0 0
Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [18] 0 0
Baseline, at Week 16
Secondary outcome [19] 0 0
Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [19] 0 0
Baseline, at Week 16
Secondary outcome [20] 0 0
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [20] 0 0
Baseline, at Week 16
Secondary outcome [21] 0 0
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [21] 0 0
Baseline, at Week 16
Secondary outcome [22] 0 0
Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [22] 0 0
Baseline, at Week 16
Secondary outcome [23] 0 0
Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Timepoint [23] 0 0
Baseline, at Week 16
Secondary outcome [24] 0 0
Change From Baseline in the SF-36 v2.0 PCS Score at Week 16 for Zasocitinib Dose B Compared to Placebo
Timepoint [24] 0 0
Baseline, at Week 16
Secondary outcome [25] 0 0
Change From Baseline in the FACIT- Fatigue Score at Week 16 for Zasocitinib Dose B Compared to Placebo
Timepoint [25] 0 0
Baseline, at Week 16
Secondary outcome [26] 0 0
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [26] 0 0
At Week 16
Secondary outcome [27] 0 0
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [27] 0 0
At Week 16
Secondary outcome [28] 0 0
Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [28] 0 0
Baseline, at Week 16
Secondary outcome [29] 0 0
Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [29] 0 0
Baseline, at Week 16
Secondary outcome [30] 0 0
Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [30] 0 0
Baseline, at Week 16
Secondary outcome [31] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Timepoint [31] 0 0
At Week 16

Eligibility
Key inclusion criteria
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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/01/2028
Actual
Sample size
Target
1088
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06671483