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Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab. | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

NCT03552276•Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

Summary

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab

Detailed Description

Subjects have rolled over from parent study, i.e., CLR\_16\_23, into the long-term extension study CLR\_18\_07. The study has been open label post 1 year completion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects may be included in the study if they meet all of the following criteria:
•1. Subject has provided written informed consent for this long-term extension study.
•3. No concomitant use of both leflunomide and methotrexate,
•4. No history of active tuberculosis (TB) or symptoms of TB.

Exclusion Criteria

•Subjects should be excluded from the study if they meet any of the following criteria:
•1. New onset during the parent study of arthritic conditions other than the subject's original condition.
•2. 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 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
•3. Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
•4. Subject has previously been enrolled in this long-term extension study.
•5. 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.
•6. 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 continued treatment to be detrimental to the subject.
•7. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study.
•8. Subjects with a history of alcohol or drug abuse during the parent study.
•9. Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
+3 more criteria

Locations (66)

Site 25

Glendale, Arizona, United States

Site 16

Phoenix, Arizona, United States

Site 14

Denver, Colorado, United States

Site 27

Wichita, Kansas, United States

Site 23

Lexington, Kentucky, United States

Site 20

Monroe, Louisiana, United States

Site 26

Lebanon, New Hampshire, United States

Site 24

Salisbury, North Carolina, United States

Site 19

Cincinnati, Ohio, United States

Site 17

Middleburg Heights, Ohio, United States

Key Dates

Start Date

July 11, 2018

Primary Completion Date

September 18, 2023

Completion Date

September 18, 2023

Last Updated

November 21, 2024

Enrollment

281

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

SUNPG18_07 I (Tildrakizumab 200 mg)

DRUG

SUNPG18_07 II (Tildrakizumab 100 mg)

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

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RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

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A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis