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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04991116




Registration number
NCT04991116
Ethics application status
Date submitted
29/07/2021
Date registered
5/08/2021
Date last updated
11/06/2024

Titles & IDs
Public title
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Scientific title
An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.
Secondary ID [1] 0 0
TILD-21-01
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 - TILD sub-cutaneous (SC) injection

Experimental: TILD q12 weeks -


Treatment: Drugs: TILD sub-cutaneous (SC) injection
1 mL injection of study medication
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and intensity of Adverse Events (AEs) recorded through the study period
Timepoint [1] 0 0
Week 124
Primary outcome [2] 0 0
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Timepoint [2] 0 0
Week 124
Primary outcome [3] 0 0
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
Timepoint [3] 0 0
Week 124
Primary outcome [4] 0 0
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70
Timepoint [4] 0 0
Week 124

Eligibility
Key inclusion criteria
* Subjects possess the ability to understand the requirements of the study.
* Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
* Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
* Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
* Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.
* Subject has previously been enrolled in this long-term extension study.
* Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,TAS
Recruitment hospital [1] 0 0
Sunpharma site no 59 - Phillip
Recruitment hospital [2] 0 0
Sunpharma site no 58 - Maroochydore
Recruitment hospital [3] 0 0
Sunpharma site no. 24 - Hobart
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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North Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
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South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
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Washington
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 2
Country [20] 0 0
Czechia
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Praha 4
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Czechia
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Zlin
Country [22] 0 0
Estonia
State/province [22] 0 0
Tallinn
Country [23] 0 0
Estonia
State/province [23] 0 0
Tartu
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Germany
State/province [24] 0 0
Berlin
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Germany
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Herne
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Italy
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Verona
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Itabashi-ku
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Japan
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Kumamoto-shi
Country [31] 0 0
Japan
State/province [31] 0 0
Mitaka
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Japan
State/province [32] 0 0
Miyazaki
Country [33] 0 0
Japan
State/province [33] 0 0
Nagoya
Country [34] 0 0
Japan
State/province [34] 0 0
Sendai-shi
Country [35] 0 0
Japan
State/province [35] 0 0
Tsu
Country [36] 0 0
Korea, Republic of
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Seoul
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Nadarzyn
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Poland
State/province [41] 0 0
Poznan
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Poland
State/province [42] 0 0
Torun
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Slovakia
State/province [44] 0 0
Martin
Country [45] 0 0
Slovakia
State/province [45] 0 0
Nové Mesto Nad Váhom
Country [46] 0 0
Slovakia
State/province [46] 0 0
Rimavska Sobota
Country [47] 0 0
Spain
State/province [47] 0 0
Cordoba
Country [48] 0 0
Spain
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Córdoba
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Spain
State/province [49] 0 0
La Coruña
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Spain
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Malaga
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Spain
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Santiago De Compostela
Country [52] 0 0
Spain
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Sevilla
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Taiwan
State/province [53] 0 0
Kaohsiung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung
Country [55] 0 0
Taiwan
State/province [55] 0 0
Tainan
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sun Pharmaceutical Industries Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An open label phase 3 study
Trial website
https://clinicaltrials.gov/study/NCT04991116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Head, Clinical Developement
Address 0 0
Country 0 0
Phone 0 0
9122 66455645
Fax 0 0
Email 0 0
Clinical.Trial@sunpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04991116