Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active P… (NCT04314531) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
United States296 participantsStarted 2020-07-01
Plain-language 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 .
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has provided written informed consent.
✓. Subject is ≥ 18 years of age at time of Screening.
✓. 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.
✓. 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
✕. The subject has a planned surgical intervention between Baseline and the Week 52 evaluation for a pretreatment condition.
✕. Subject has an active infection or history of infections as follows:
✕. 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.
✕. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
✕. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
✕. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
What they're measuring
1
The proportion of subjects who achieve American College of Rheumatology [ACR20]
✕. Subjects with a history of alcohol or drug abuse in the previous 2 years.
✕. 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.