CompletedPhase 3

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

United States508 participantsStarted 2020-07-01

Plain-language 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)

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.
✓. RF and anti-CCP Ab negative.
✓. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

Exclusion criteria

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

What they're measuring

The proportion of subjects who achieve American College of Rheumatology [ACR20]

Timeframe: at week 24

Trial details

NCT IDNCT04314544

SponsorSun Pharmaceutical Industries Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-26

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