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Clinical Trials in the USA / NCT04314531
Active, not recruiting Phase 3

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

NCT04314531 · tracked via the Priya Life Science USA tracker
Sponsor
Sun Pharmaceutical Industries Limited
Phase
Phase 3
Started
2020-07-01
Last updated
2026-03-10

Condition(s) studied

Active Psoriatic Arthritis

Investigational drug(s) / intervention(s)

TILDmatching placebo injections

TILD: one 1 mL injection of study medication

matching placebo injections: one 1 mL injection of placebo

Study summary

This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subject has provided written informed consent. 2. Subject is ≥ 18 years of age at time of Screening. 3. Subject has a diagnosis of active PsA for at least 6 months before the first administration of the study agent and has active PsA at Screening or Baseline. 4. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative. 5. Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA. Exclusion Criteria: 1. The subject has a planned surgical intervention between Baseline and the Week 52 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 intravenous (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 any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause this study to be detrimental to the subject. 4. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 5. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose. 6. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. 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 signing the Informed Consent and through 24 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 follicle-stimulating hormone (FSH) test should be performed to confirm menopause (per reference values of the laboratory) 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 milliliter (mL) or more of blood within 8 weeks before first dose of IMP. 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 outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Sunpharma site no. 12 Covina California
Sunpharma site no. 04 Miami Beach Florida
Sunpharma site no. 02 New Port Richey Florida
Sunpharma site no. 07 Tamarac Florida
Sunpharma site no. 05 Springfield Missouri
Sunpharma site no. 10 Lincoln Nebraska
Sunpharma site no. 11 Greenville South Carolina
Sunpharma site no. 09 Lubbock Texas
Sunpharma site no. 03 San Antonio Texas
Sunpharma site no. 01 Tomball Texas
Sunpharma site no. 06 Spokane Washington
Sunpharma Site 39 Phillip Australian Capital Territory
Sunpharma site no. 08 Hobart Tasmania
Sunpharma Site 64 Brno Czechia
Sunpharma Site 97 Prague Czechia
Sunpharma Site 63 Zlín Czechia
Sunpharma Site 73 Berlin Germany
Sunpharma Site 92 Herne Germany
Sunpharma Site 111 Surat Gujarat
Sunpharma Site 110 Bangalore Karnataka
Sunpharma Site 107 Belagavi Karnataka
Sunpharma Site 109 Hubli Karnataka
Sunpharma Site 108 Pune Maharashtra
Sunpharma Site 112 Hyderabad Telangana
Sunpharma Site 106 Lucknow Uttar Pradesh
Sunpharma Site 113 Kochi India
Sunpharma Site 84 Nagoya Aichi-ken
Sunpharma Site 89 Kitakyushu Fukuoka
Sunpharma Site 86 Sendai Miyagi
Sunpharma Site 24 Miyazaki Miyazaki
Sunpharma Site 91 Mitaka Tokyo
Sunpharma Site 85 Shinjuku Tokyo
Sunpharma Site 90 tabashi City Tokyo
Sunpharma Site 22 Kitakyushu-shi Japan
Sunpharma Site 88 Kumamoto Japan
Sunpharma Site 87 Osaka Japan
Sunpharma Site 23 Tsu Japan
Sunpharma Site 93 Bialystok Poland
Sunpharma Site 95 Bialystok Poland
Sunpharma Site 94 Lublin Poland

+ 9 more sites — see the full list on the official registry below.

More Sun Pharmaceutical Industries Limited trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04314531 on ClinicalTrials.gov ↗ ← All trials in the USA