Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Study Purpose

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 .

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:

1. Subject has provided written informed consent. 2. Subject is ≥ 18 years of age at time of Screening. 3. 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. 4. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative. 5. 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:

1. The subject has a planned surgical intervention between Baseline and the Week 52 evaluation 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 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening, - a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening, - recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
3. 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. 4. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 5. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose. 6. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. 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 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 16 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. 9. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving 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, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. Donation or loss of 400 milliliter (mL) or more of blood within 8 weeks before first dose of IMP. 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 site such that a conflict of interest could arise.

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.

NCT04314531
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 Pharma Global FZE
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, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Active Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Arm A

Placebo Comparator: Arm B

Interventions

Drug: - TILD

one 1 mL injection of study medication

Drug: - matching placebo injections

one 1 mL injection of placebo

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. 12, Covina, California

Status

Not yet recruiting

Address

Sunpharma site no. 12

Covina, California, 91722

Site Contact

Samy Metyas, M.D.

[email protected]

626-860-5730

Sunpharma site no. 04, Hialeah, Florida

Status

Recruiting

Address

Sunpharma site no. 04

Hialeah, Florida, 33016

Site Contact

Carlos A Sesin, M.D.

[email protected]

305-456-9062

Sunpharma site no. 02, New Port Richey, Florida

Status

Recruiting

Address

Sunpharma site no. 02

New Port Richey, Florida, 34668

Site Contact

Farrukh Zaidi, M.D.

[email protected]

727-849-4131

Sunpharma site no. 07, Tamarac, Florida

Status

Active, not recruiting

Address

Sunpharma site no. 07

Tamarac, Florida, 33321

Sunpharma site no. 13, Decatur, Georgia

Status

Not yet recruiting

Address

Sunpharma site no. 13

Decatur, Georgia, 30033

Site Contact

Jefrey Lieberman, M.D.

[email protected]

770-667-0220

Sunpharma site no. 14, Lake Charles, Louisiana

Status

Not yet recruiting

Address

Sunpharma site no. 14

Lake Charles, Louisiana, 70605

Site Contact

Enrique Mendez, M.D.

[email protected]

337-312-8619

Sunpharma site no. 05, Springfield, Missouri

Status

Active, not recruiting

Address

Sunpharma site no. 05

Springfield, Missouri, 65810

Sunpharma site no. 10, Lincoln, Nebraska

Status

Not yet recruiting

Address

Sunpharma site no. 10

Lincoln, Nebraska, 68516

Site Contact

Melvin Churchill, M.D.

[email protected]

402-420-3433

Sunpharma site no. 11, Greenville, South Carolina

Status

Not yet recruiting

Address

Sunpharma site no. 11

Greenville, South Carolina, 29601

Site Contact

Jeff Lawson, M.D.

[email protected]

864-527-2307

Sunpharma site no. 09, Lubbock, Texas

Status

Not yet recruiting

Address

Sunpharma site no. 09

Lubbock, Texas, 79410

Site Contact

Jitendra Vasandani, M.D.

[email protected]

806-993-1040

Sunpharma site no. 03, San Antonio, Texas

Status

Recruiting

Address

Sunpharma site no. 03

San Antonio, Texas, 78229

Site Contact

Pendleton B Wickersham, M.D.

[email protected]

210-477-2626

Sunpharma site no. 01, Tomball, Texas

Status

Recruiting

Address

Sunpharma site no. 01

Tomball, Texas, 77375

Site Contact

Shaikh Arif Ali, M.D.

[email protected]

281-517-0550

Sunpharma site no. 06, Spokane, Washington

Status

Active, not recruiting

Address

Sunpharma site no. 06

Spokane, Washington, 99204

International Sites

Sunpharma site no. 08, Hobart, Tasmania, Australia

Status

Not yet recruiting

Address

Sunpharma site no. 08

Hobart, Tasmania, 7000

Site Contact

Jane Zochling, Mmed, FRACP

[email protected]

61 3 6223 8802

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