Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Study Purpose

An open label phase 3 study

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subjects possess the ability to understand the requirements of the study.

- Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.

- Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.

- Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.

Exclusion Criteria:

- Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.

- Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.

- Subject has previously been enrolled in this long-term extension study.

- Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04991116
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sun Pharmaceutical Industries Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Czechia, Estonia, Germany, India, Italy, Japan, Poland, Slovakia, South Korea, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis

Additional Details

Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).

Arms & Interventions

Arms

Experimental: TILD q12 weeks

Interventions

Drug: - TILD sub-cutaneous (SC) injection

1 mL injection of study medication

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sunpharma site no 50, Dothan 4059102, Alabama 4829764

Status

Recruiting

Address

Sunpharma site no 50

Dothan 4059102, Alabama 4829764, 36305

Site Contact

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