Clinical trial NCT04991116: Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Official title: An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label phase 3 study

Detailed description: Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Incidence and intensity of Adverse Events (AEs) recorded through the study period
timeFrame: Week 124
measure: Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
timeFrame: Week 124
measure: Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
timeFrame: Week 124
measure: Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70
timeFrame: Week 124
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Sunpharma site no 50
state: Alabama
city: Gilbert
country: United States
facility: Sunpharma site no 80
state: Arizona
city: Mesa
country: United States
facility: Sunpharma site no 65
state: Arizona
city: Phoenix
country: United States
facility: Sunpharma site no 105
state: Arizona
city: Covina
country: United States
facility: Sunpharma site no. 30
state: California
city: Fountain Valley
country: United States
facility: Sunpharma site no. 17
state: California
city: Thousand Oaks
country: United States
facility: Sunpharma site no. 15
state: California
city: Clearwater
country: United States
facility: Sunpharma site no. 21
state: Florida
city: Hialeah
country: United States
facility: Sunpharma site no. 02
state: Florida
city: Kissimmee
country: United States
facility: Sunpharma site no 71
state: Florida
city: Margate
country: United States
facility: Sunpharma site no 107
state: Florida
city: New Port Richey
country: United States
facility: Sunpharma site no. 05
state: Florida
city: Ocoee
country: United States
facility: Sunpharma site no 32
state: Florida
city: Tamarac
country: United States
facility: SunPharma Site no 22
state: Florida
city: Gainesville
country: United States
facility: Sunpharma site no 52
state: Georgia
city: Orland Park
country: United States
facility: Sunpharma site no 51
state: Illinois
city: Schaumburg
country: United States
facility: Sunpharma site no 49
state: Illinois
city: Skokie
country: United States
facility: Sunpharma site no 47
state: Illinois
city: Wichita
country: United States
facility: Sunpharma site no. 20
state: Kansas
city: Saint Louis
country: United States
facility: Sunpharma site no 104
state: Missouri
city: Springfield
country: United States
facility: Sunpharma site no. 14
state: Missouri
city: Kalispell
country: United States
facility: Sunpharma site no 48
state: Montana
city: Lincoln
country: United States
facility: Sunpharma Site no 27
state: Nebraska
city: Voorhees
country: United States
facility: Sunpharma site no 33
state: New Jersey
city: Charlotte
country: United States
facility: Sunpharma site no 34
state: North Carolina
city: Wilmington
country: United States
facility: Sunpharma site no 53
state: North Carolina
city: Minot
country: United States
facility: Sunpharma site no 35
state: North Dakota
city: Middleburg Heights
country: United States
facility: Sunpharma site no. 11
state: Ohio
city: Greenville
country: United States
facility: Sunpharma site no 31
state: South Carolina
city: Baytown
country: United States
facility: Sunpharma site no. 08
state: Texas
city: Baytown
country: United States
facility: Sunpharma site no. 13
state: Texas
city: Lubbock
country: United States
facility: Sunpharma Site no 28
state: Texas
city: San Antonio
country: United States
facility: Sunpharma site no. 03
state: Texas
city: San Antonio
country: United States
facility: Sunpharma site no. 16
state: Texas
city: Tomball
country: United States
facility: Sunpharma site no. 01
state: Texas
city: Salt Lake City
country: United States
facility: Sunpharma site no 96
state: Utah
city: Spokane
country: United States
facility: Sunpharma site no 66
state: Washington
city: Phillip
country: Australia
facility: Sunpharma site no 59
state: Australian Capital Territory
city: Maroochydore
country: Australia
facility: Sunpharma site no 58
state: Queensland
city: Hobart
country: Australia
facility: Sunpharma site no. 24
state: Tasmania
city: Trois-Rivières
country: Canada
facility: Sunpharma site no 95
city: Brno
country: Czechia
facility: Sunpharma site no 36
city: Praha 2
country: Czechia
facility: Sunpharma site no 67
city: Praha 4
country: Czechia
facility: Sunpharma site no 89
city: Zlin
country: Czechia
facility: Sunpharma site no 82
city: Tallinn
country: Estonia
facility: Sunpharma site no 44
city: Tartu
country: Estonia
facility: Sunpharma site no 39
city: Tartu
country: Estonia
facility: Sunpharma site no 40
city: Berlin
country: Germany
facility: Sunpharma site no 37
city: Herne
country: Germany
facility: Sunpharma site no 83
city: Surat
country: India
facility: Sunpharma site no 92
state: Gujrat
city: Belgaum
country: India
facility: Sunpharma site no 101
state: Karnataka
city: Hubli
country: India
facility: Sunpharma site no 91
state: Karnataka
city: Pune
country: India
facility: Sunpharma site no 108
state: MH
city: Chennai
country: India
facility: Sunpharma site no 93
state: Tamil Nadu
city: Bangalore
country: India
facility: Sunpharma site no 100
state: TN
city: Chennai
country: India
facility: Sunpharma site no 103
state: TN
city: Secunderabad
country: India
facility: Sunpharma site no 102
city: Sevilla
country: India
facility: Sunpharma site no 94
city: Verona
country: Italy
facility: Sunpharma site no 90
city: Shinjuku-ku
country: Japan
facility: Sunpharma site no 73
state: Tokyo
city: Fukuoka
country: Japan
facility: Sunpharma site no 45
city: Itabashi-ku
country: Japan
facility: Sunpharma site no 84
city: Kumamoto-shi
country: Japan
facility: Sunpharma site no 46
city: Mitaka
country: Japan
facility: Sunpharma site no 72
city: Miyazaki
country: Japan
facility: Sunpharma site no 79
city: Nagoya
country: Japan
facility: Sunpharma site no 78
city: Sendai-shi
country: Japan
facility: Sunpharma site no 64
city: Sendai-shi
country: Japan
facility: Sunpharma site no 63
city: Tsu
country: Japan
facility: Sunpharma site no 87
city: Seoul
country: Korea, Republic of
facility: Sunpharma site no 98
city: Seoul
country: Korea, Republic of
facility: Sunpharma site no 70
city: Bialystok
country: Poland
facility: Sunpharma site no 43
city: Bialystok
country: Poland
facility: Sunpharma site no 69
city: Krakow
country: Poland
facility: Sunpharma site no 56
city: Lublin
country: Poland
facility: Sunpharma site no 81
city: Nadarzyn
country: Poland
facility: Sunpharma site no 55
city: Olsztyn
country: Poland
facility: Sunpharma site no 106
city: Poznan
country: Poland
facility: Sunpharma site no 85
city: Poznan
country: Poland
facility: Sunpharma site no 68
city: Torun
country: Poland
facility: Sunpharma site no 60
city: Warszawa
country: Poland
facility: Sunpharma site no 61
city: Martin
country: Slovakia
facility: Sunpharma site no 74
city: Nové Mesto Nad Váhom
country: Slovakia
facility: Sunpharma site no 42
city: Rimavska Sobota
country: Slovakia
facility: Sunpharma site no 41
city: Cordoba
country: Spain
facility: Sunpharma site no 38
city: Córdoba
country: Spain
facility: SunPharma Site No 23
city: La Coruña
country: Spain
facility: Sunpharma site no 57
city: Malaga
country: Spain
facility: Sunpharma site no 86
city: Santiago De Compostela
country: Spain
facility: Sunpharma site no 88
city: Sevilla
country: Spain
facility: Sunpharma site no 62
city: Valencia
country: Spain
facility: Sunpharma site no 97
city: Kaohsiung
country: Taiwan
facility: Sunpharma site no 76
city: Taichung
country: Taiwan
facility: Sunpharma site no 54
city: Taichung
country: Taiwan
facility: Sunpharma site no 99
city: Tainan
country: Taiwan
facility: Sunpharma site no 75
city: Taipei
country: Taiwan
facility: Sunpharma site no 77
Study officials:
References: