Clinical trial NCT04314544: Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Official title: A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Active Psoriatic Arthritis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)


Eligibility criteria: Inclusion Criteria:

1. Subject has provided written informed consent.
2. Subject is ≥ 18 years of age at time of Screening.
3. RF and anti-CCP Ab negative.
4. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

Exclusion Criteria:

1. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.
2. Subject has an active infection or history of infections as follows:

   * any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,
   * a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
   * recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
3. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
4. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
5. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
6. Subject has a history of malignancy within 5 years from the time of Screening EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
7. Subjects with a history of alcohol or drug abuse in the previous 2 years.
8. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year.
9. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s).
10. Subject previously has been enrolled (randomized) in this study.
11. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
12. Donation or loss of 400 mL or more of blood within 8 weeks before dosing.
13. Subjects who have been placed in an institution on official or judicial orders.
14. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

Primary outcomes:
measure: The proportion of subjects who achieve American College of Rheumatology [ACR20]
timeFrame: at week 24
Secondary outcomes:
measure: The proportion of subjects achieving American College of Rheumatology [ACR50]
timeFrame: at Week 24
measure: The proportion of subjects achieving American College of Rheumatology [ACR70]
timeFrame: at Week 24
measure: The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline
timeFrame: at Weeks 24
measure: The change from Baseline in the van der Heijde modified total Sharp score
timeFrame: at Week 24
measure: The change from Baseline in the van der Heijde modified total Sharp score
timeFrame: at Week 16
measure: Change from Baseline in American College of Rheumatology Response Criteria Components Score
timeFrame: at Week 24
measure: change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: at Week 24
measure: change from Baseline in Leeds Enthesitis Index
timeFrame: at Week 24
measure: The change from Baseline in Leeds Dactylitis Index
timeFrame: at Week 24
measure: The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2
timeFrame: at Week 24
measure: The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
timeFrame: at Week 24
measure: The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
timeFrame: at Week 24.
measure: The proportion of subjects with active Psoriasis and Body surface area ≥3%
timeFrame: at Week 24
measure: The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" )
timeFrame: at Week 24
measure: The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
timeFrame: at week 52
measure: The change from Baseline in American College of Rheumatology Response Criteria Components Score
timeFrame: at Week 52
measure: The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: at Week 52
measure: The change from Baseline
timeFrame: at Week 52
measure: The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
timeFrame: at Week 52
measure: The change from Baseline in van der Heijde modified total Sharp score
timeFrame: at Week 52
measure: The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
timeFrame: at Week 52
measure: The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
timeFrame: at Week 52
measure: In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects
timeFrame: at Week 52
measure: In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index
timeFrame: at Week 52
measure: In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
timeFrame: at Week 52
measure: Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
timeFrame: at Week 24
measure: The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
timeFrame: Weeks 24 and 52
measure: The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
timeFrame: at Week 24
Other outcomes:
measure: The proportion of subjects achieving American College of Rheumatology [ACR20]
timeFrame: Weeks 24 and 52
measure: The proportion of subjects achieving American College of Rheumatology [ACR50]
timeFrame: Weeks 24 and 52
measure: The proportion of subjects achieving American College of Rheumatology [ACR70]
timeFrame: Weeks 24 and 52
measure: The change from Baseline in American College of Rheumatology Response Criteria Components Score
timeFrame: Weeks 24 and 52
measure: The change from Baseline
timeFrame: Weeks 24 and 52
measure: The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2
timeFrame: Weeks 24 and 52
measure: The proportion of subjects with active Psoriasis and Body surface area ≥ 3%
timeFrame: Weeks 24 and 52
measure: The change from Baseline in the levels of "Metabolic Biomarkers"
timeFrame: at Week 24
measure: the change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
timeFrame: at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52
measure: proportion of subjects who achieve a response based on Modified Psoriatic Arthritis Responder Criteria (PsARC)
timeFrame: at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52.
measure: change from baseline in Work Productivity and Activity Impairment Questionnaire Scores
timeFrame: at Week 12,16 24, 48 and 52
measure: change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: at Week 8,16, 24 and 52.
Locations:
city: Dothan
country: United States
facility: Sunpharma Site no 42
state: Alabama
city: Gilbert
country: United States
facility: Sunpharma Site no 29
state: Arizona
city: Glendale
country: United States
facility: Sunpharma Site no 30
state: Arizona
city: Mesa
country: United States
facility: Sunpharma Site no 31
state: Arizona
city: Covina
country: United States
facility: Sunpharma Site no 35
state: California
city: Encino
country: United States
facility: Sunpharma Site no 48
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: Denver
country: United States
facility: Sunpharma Site no 40
state: Colorado
city: Fort Collins
country: United States
facility: Sunpharma Site no 36
state: Colorado
city: Avon Park
country: United States
facility: Sunpharma Site no. 141
state: Florida
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 55
state: Florida
city: Margate
country: United States
facility: Sunpharma Site no. 75
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. 76
state: Florida
city: Tamarac
country: United States
facility: SunPharma Site no 22
state: Florida
city: Gainesville
country: United States
facility: Sunpharma Site no 46
state: Georgia
city: Oak Brook
country: United States
facility: Sunpharma Site no 41
state: Illinois
city: Orland Park
country: United States
facility: Sunpharma Site no 54
state: Illinois
city: Schaumburg
country: United States
facility: Sunpharma Site no 38
state: Illinois
city: Skokie
country: United States
facility: Sunpharma Site no 37
state: Illinois
city: Skokie
country: United States
facility: Sunpharma Site no. 122
state: Illinois
city: Wichita
country: United States
facility: Sunpharma site no. 20
state: Kansas
city: Worcester
country: United States
facility: Sunpharma site no. 07
state: Massachusetts
city: Eagan
country: United States
facility: Sunpharma Site no 45
state: Minnesota
city: Saint Louis
country: United States
facility: Sunpharma Site no. 123
state: Missouri
city: Springfield
country: United States
facility: Sunpharma site no. 14
state: Missouri
city: Kalispell
country: United States
facility: Sunpharma Site no 53
state: Montana
city: Lincoln
country: United States
facility: Sunpharma Site no 27
state: Nebraska
city: Voorhees
country: United States
facility: Sunpharma Site no 44
state: New Jersey
city: Charlotte
country: United States
facility: Sunpharma Site no 52
state: North Carolina
city: Leland
country: United States
facility: Sunpharma Site no. 73
state: North Carolina
city: Wilmington
country: United States
facility: Sunpharma Site no 56
state: North Carolina
city: Minot
country: United States
facility: Sunpharma Site no 33
state: North Dakota
city: Middleburg Heights
country: United States
facility: Sunpharma site no. 11
state: Ohio
city: Oklahoma City
country: United States
facility: Sunpharma Site no. 124
state: Oklahoma
city: Wyomissing
country: United States
facility: Sunpharma site no. 25
state: Pennsylvania
city: Greenville
country: United States
facility: Sunpharma Site no 34
state: South Carolina
city: Austin
country: United States
facility: Sunpharma Site no 50
state: Texas
city: Baytown
country: United States
facility: Sunpharma site no. 13
state: Texas
city: Colleyville
country: United States
facility: Sunpharma Site no 49
state: Texas
city: Houston
country: United States
facility: Sunpharma site no. 08
state: Texas
city: League City
country: United States
facility: Sunpharma site no. 04
state: Texas
city: Lubbock
country: United States
facility: Sunpharma Site no 28
state: Texas
city: Mesquite
country: United States
facility: Sunpharma Site no. 74
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: Stafford
country: United States
facility: Sunpharma Site no 26
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. 121
state: Utah
city: Phillip
country: Australia
facility: Sunpharma Site no. 81
state: Australian Capital Territory
city: Hobart
country: Australia
facility: Sunpharma site no. 24
state: Tasmania
city: Fitzroy
country: Australia
facility: Sunpharma Site no. 82
state: Victoria
city: Trois-Rivières
country: Canada
facility: Sunpharma site 98
state: Quebec
city: Brno
country: Czechia
facility: Sun pharma site 99
city: Prague 2
country: Czechia
facility: Sunpharma Site no. 100
city: Praha 4
country: Czechia
facility: Sunpharma Site no. 101
city: Zlín
country: Czechia
facility: Sunpharma Site no. 96
city: Tallinn
country: Estonia
facility: Sunpharma Site no. 85
city: Tallin
country: Estonia
facility: Sunpharma site no. 102
city: Tartu
country: Estonia
facility: Sunpharma Site no. 87
city: Tartu
country: Estonia
facility: Sunpharma Site no. 86
city: Berlin
country: Germany
facility: Sunpharma Site no. 91
city: Herne
country: Germany
facility: Sunpharma Site no. 103
city: Mylapore
country: India
facility: Sunpharma Site no. 128
state: Chennai
city: Surat
country: India
facility: Sunpharma Site no. 134
state: Gujarat
city: Bangalore
country: India
facility: Sunpharma Site no. 127
state: Karnataka
city: Belgaum
country: India
facility: Sunpharma Site no. 130
state: Karnataka
city: Hubli
country: India
facility: Sunpharma Site no. 132
state: Karnataka
city: Pune
country: India
facility: Sunpharma Site no. 131
state: Maharashtra
city: Pune
country: India
facility: Sunpharma Site no. 142
state: Maharashtra
city: Hyderabad
country: India
facility: Sunpharma Site no. 135
state: Telangana
city: Lucknow
country: India
facility: Sunpharma Site no. 129
state: Uttar Pradesh
city: Milan
country: Italy
facility: Sunpharma Site no. 104
city: Milan
country: Italy
facility: Sunpharma Site no. 140
city: Verona
country: Italy
facility: Sunpharma Site no. 138
city: Incheon
country: Korea, Republic of
facility: Sunpharma Site no 69
city: Seoul
country: Korea, Republic of
facility: Sunpharma Site no 71
city: Seoul
country: Korea, Republic of
facility: Sunpharma Site no 70
city: Warsaw
country: Poland
facility: Sunpharma Site no. 95
state: Mazowiecki
city: Bialystok
country: Poland
facility: Sunpharma Site no. 93
city: Białystok
country: Poland
facility: Sunpharma Site no. 110
city: Katowice
country: Poland
facility: Sunpharma Site no. 139
city: Krakow
country: Poland
facility: Sunpharma Site no. 94
city: Lublin
country: Poland
facility: Sunpharma Site no. 107
city: Olsztyn
country: Poland
facility: Sunpharma Site no. 136
city: Ponzan
country: Poland
facility: Sunpharma Site no. 106
city: Poznan
country: Poland
facility: Sunpharma Site no. 92
city: Torun
country: Poland
facility: Sunpharma Site no. 108
city: Warszawa
country: Poland
facility: Sunpharma Site no. 111
city: Wroclaw
country: Poland
facility: Sunpharma Site no. 137
city: Martin
country: Slovakia
facility: Sunpharma Site no. 88
city: Rimavska Sobota
country: Slovakia
facility: Sunpharma Site no. 113
city: Vahom
country: Slovakia
facility: Sunpharma Site no. 112
city: Córdoba
country: Spain
facility: SunPharma Site No 23
city: La Coruña
country: Spain
facility: Sunpharma Site no 58
city: Madrid
country: Spain
facility: Sunpharma Site no. 78
city: Malaga
country: Spain
facility: Sunpharma Site no. 116
city: Sabadell
country: Spain
facility: Sunpharma Site no. 125
city: Santiago de Compostela
country: Spain
facility: Sunpharma Site no. 115
city: Sevilla
country: Spain
facility: Sunpharma Site no. 77
city: Sevilla
country: Spain
facility: Sunpharma Site no. 117
city: Valencia
country: Spain
facility: Sunpharma Site no 59
city: Taipei
country: Taiwan
facility: Sunpharma Site no 65
state: Pai-Tou
city: Jianguo
country: Taiwan
facility: Sunpharma Site no 63
state: Taichung
city: Hsinchu
country: Taiwan
facility: Sunpharma Site no. 79
city: Kaohsiung
country: Taiwan
facility: Sunpharma Site no. 80
city: Kaohsiung
country: Taiwan
facility: Sunpharma Site no 62
city: Tainan
country: Taiwan
facility: Sunpharma Site no 60
city: Taipei
country: Taiwan
facility: Sunpharma Site no 64
Study officials:
References: