Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
NCT ID: NCT04314544
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
508 participants
INTERVENTIONAL
2020-07-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A
TILD
one 1 mL injection of study medication
Arm B
matching placebo injections
one 1 mL injection of placebo
Interventions
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TILD
one 1 mL injection of study medication
matching placebo injections
one 1 mL injection of placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Sunpharma Site no 42
Dothan, Alabama, United States
Sunpharma Site no 29
Gilbert, Arizona, United States
Sunpharma Site no 30
Glendale, Arizona, United States
Sunpharma Site no 31
Mesa, Arizona, United States
Sunpharma Site no 35
Covina, California, United States
Sunpharma Site no 48
Encino, California, United States
Sunpharma site no. 17
Fountain Valley, California, United States
Sunpharma site no. 15
Thousand Oaks, California, United States
Sunpharma Site no. 141
Avon Park, Florida, United States
Sunpharma site no. 21
Clearwater, Florida, United States
Sunpharma site no. 02
Hialeah, Florida, United States
Sunpharma Site no 55
Kissimmee, Florida, United States
Sunpharma Site no. 75
Margate, Florida, United States
Sunpharma site no. 05
New Port Richey, Florida, United States
Sunpharma Site no. 76
Ocoee, Florida, United States
SunPharma Site no 22
Tamarac, Florida, United States
Sunpharma Site no 46
Gainesville, Georgia, United States
Sunpharma Site no 41
Oak Brook, Illinois, United States
Sunpharma Site no 54
Orland Park, Illinois, United States
Sunpharma Site no 38
Schaumburg, Illinois, United States
Sunpharma Site no 37
Skokie, Illinois, United States
Sunpharma Site no. 122
Skokie, Illinois, United States
Sunpharma site no. 20
Wichita, Kansas, United States
Sunpharma site no. 07
Worcester, Massachusetts, United States
Sunpharma site no. 14
Springfield, Missouri, United States
Sunpharma Site no 53
Kalispell, Montana, United States
Sunpharma Site no 27
Lincoln, Nebraska, United States
Sunpharma Site no 44
Voorhees Township, New Jersey, United States
Sunpharma Site no 52
Charlotte, North Carolina, United States
Sunpharma Site no. 73
Leland, North Carolina, United States
Sunpharma Site no 56
Wilmington, North Carolina, United States
Sunpharma Site no 33
Minot, North Dakota, United States
Sunpharma site no. 11
Middleburg Heights, Ohio, United States
Sunpharma Site no. 124
Oklahoma City, Oklahoma, United States
Sunpharma Site no 34
Greenville, South Carolina, United States
Sunpharma Site no 50
Austin, Texas, United States
Sunpharma site no. 13
Baytown, Texas, United States
Sunpharma Site no 49
Colleyville, Texas, United States
Sunpharma site no. 08
Houston, Texas, United States
Sunpharma Site no 28
Lubbock, Texas, United States
Sunpharma Site no. 74
Mesquite, Texas, United States
Sunpharma site no. 16
San Antonio, Texas, United States
Sunpharma Site no 26
Stafford, Texas, United States
Sunpharma site no. 01
Tomball, Texas, United States
Sunpharma Site no. 121
Salt Lake City, Utah, United States
Sunpharma site 98
Trois-Rivières, Quebec, Canada
Sun pharma site 99
Brno, , Czechia
Sunpharma Site no. 100
Prague, , Czechia
Sunpharma Site no. 101
Prague, , Czechia
Sunpharma Site no. 96
Zlín, , Czechia
Sunpharma Site no. 85
Tallinn, , Estonia
Sunpharma Site no. 87
Tartu, , Estonia
Sunpharma Site no. 86
Tartu, , Estonia
Sunpharma Site no. 91
Berlin, , Germany
Sunpharma Site no. 103
Herne, , Germany
Sunpharma Site no. 128
Mylapore, Chennai, India
Sunpharma Site no. 134
Surat, Gujarat, India
Sunpharma Site no. 127
Bangalore, Karnataka, India
Sunpharma Site no. 130
Belagavi, Karnataka, India
Sunpharma Site no. 132
Hubli, Karnataka, India
Sunpharma Site no. 143
Kochi, Kerala, India
Sunpharma Site no. 131
Pune, Maharashtra, India
Sunpharma Site no. 142
Pune, Maharashtra, India
Sunpharma Site no. 129
Lucknow, Uttar Pradesh, India
Sunpharma Site no. 144
Kolkata, West Bengal, India
Sunpharma Site no. 104
Milan, , Italy
Sunpharma Site no. 138
Verona, , Italy
Sunpharma Site no. 95
Warsaw, Mazowiecki, Poland
Sunpharma Site no. 110
Bialystok, , Poland
Sunpharma Site no. 93
Bialystok, , Poland
Sunpharma Site no. 139
Katowice, , Poland
Sunpharma Site no. 94
Krakow, , Poland
Sunpharma Site no. 107
Lublin, , Poland
Sunpharma Site no. 136
Olsztyn, , Poland
Sunpharma Site no. 106
Ponzan, , Poland
Sunpharma Site no. 92
Poznan, , Poland
Sunpharma Site no. 108
Torun, , Poland
Sunpharma Site no. 111
Warsaw, , Poland
Sunpharma Site no. 137
Wroclaw, , Poland
Sunpharma Site no. 88
Martin, , Slovakia
Sunpharma Site no. 112
Vahom, , Slovakia
Sunpharma Site no 71
Seoul, , South Korea
Sunpharma Site no 70
Seoul, , South Korea
Sunpharma Site no 58
A Coruña, , Spain
SunPharma Site No 23
Córdoba, , Spain
Sunpharma Site no. 78
Madrid, , Spain
Sunpharma Site no. 116
Málaga, , Spain
Sunpharma Site no. 125
Sabadell, , Spain
Sunpharma Site no. 115
Santiago de Compostela, , Spain
Sunpharma Site no. 117
Seville, , Spain
Sunpharma Site no 59
Valencia, , Spain
Sunpharma Site no 65
Taipei, Pai-Tou, Taiwan
Sunpharma Site no 63
Jianguo, Taichung, Taiwan
Sunpharma Site no. 79
Hsinchu, , Taiwan
Sunpharma Site no 62
Kaohsiung City, , Taiwan
Sunpharma Site no 60
Tainan, , Taiwan
Sunpharma Site no 64
Taipei, , Taiwan
Countries
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Other Identifiers
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TILD-19-07
Identifier Type: -
Identifier Source: org_study_id