Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

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 PsOor PsA.

Exclusion Criteria:

1. Subject has a planned surgical intervention between Baseline and the Week 24evaluation 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 28days prior to first IMP dose, with the last dose having been received within 7days of Screening,

• a serious infection, defined as requiring hospitalization or IV anti-infectiveswithin 8 weeks prior to the first IMP dose, with the last dose having beenreceived within 7 days of Screening,

• recurrent or chronic infections, e.g., chronic pyelonephritis, chronicosteomyelitis, bronchiectasis, or other active infection that, in the opinionof 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 humanimmunodeficiency virus.

4. Subject had myocardial infarction, unstable angina pectoris, or ischemic strokewithin the past 6 months prior to the first IMP dose.

5. Subject has any active malignancy, including evidence of cutaneous basal or squamouscell carcinoma or melanoma.

6. Subject has a history of malignancy within 5 years from the time of Screening EXCEPTtreated and considered cured cutaneous basal or squamous cell carcinoma, in situcervical 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 fromheterosexual activity or practice a dual method of contraception, for example, acombination of the following: (1) oral contraceptive, depo progesterone, orintrauterine device; and (2) a barrier method (condom or diaphragm). Male subjectswith female partners of childbearing potential who are not using birth control asdescribed above must use a barrier method of contraception (e.g., condom) if notsurgically sterile (i.e., vasectomy). Contraceptive methods must be practiced uponentering the study and through 17 weeks after the last dose of IMP. If a subjectdiscontinues prematurely, the contraceptive method must be practiced for 17 weeksfollowing final administration of IMP. A FSH test should be performed to confirmmenopause for those women with no menses for less than 1 year.

9. Subject currently enrolled in another investigational device/procedure or drugstudy, or Baseline of this study is less than 30 days or 5 half-lives (whichever islonger) since ending another investigational device/procedure or drug study(s), orreceiving 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, maycompromise the ability of the subject to give written informed consent and/or tocomply 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 sitesuch that a conflict of interest could arise.