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

NCT04314531 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TILD-19-19
• Study Type: interventional
• Target: 296
• Locations: 9 countries
• Sites: 49

Brief Summary

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 .

Conditions

Active Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

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

  the proportion of subjects achieving a 20% reduction from Baseline in response criteria

  at Week 24

Secondary Outcomes (28)

• The proportion of subjects achieving American College of Rheumatology [ACR50]

  at Week 24

• The proportion of subjects achieving American College of Rheumatology [ACR70]

  at Week 24

• The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with body surface area ≥3% at baseline

  at Weeks 24

• The change from Baseline in the van der Heijde modified total Sharp score

  Week 24

• The change from Baseline in the van der Heijde modified total Sharp score

  at Week 16

Other Outcomes (12)

• The proportion of subjects achieving American College of Rheumatology [ACR20]

  exclusive of Weeks 24 and 52

• The proportion of subjects achieving American College of Rheumatology [ACR50]

  exclusive of Weeks 24 and 52

• The proportion of subjects achieving American College of Rheumatology [ACR70]

  exclusive of Weeks 24 and 52

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: TILD

Arm B

PLACEBO COMPARATOR

Drug: matching placebo injections

Interventions

TILD DRUG

one 1 mL injection of study medication

Arm A

matching placebo injections DRUG

one 1 mL injection of placebo

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent.
• Subject is ≥ 18 years of age at time of Screening.
• 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.
• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
• Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.

You may not qualify if:

• The subject has a planned surgical intervention between Baseline and the Week 52 evaluation for a pretreatment condition.
• 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.
• 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.
• 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.
• 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 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 17 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.
• 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).
• Subject previously has been enrolled (randomized) in this study.
• 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.
• Donation or loss of 400 milliliter (mL) or more of blood within 8 weeks before first dose of IMP.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (49)

Sunpharma site no. 12

Covina, California, 91722, United States

Location

Sunpharma site no. 04

Miami Beach, Florida, 33140, United States

Location

Sunpharma site no. 02

New Port Richey, Florida, 34652, United States

Location

Sunpharma site no. 07

Tamarac, Florida, 33321, United States

Location

Sunpharma site no. 05

Springfield, Missouri, 65810, United States

Location

Sunpharma site no. 10

Lincoln, Nebraska, 68516, United States

Location

Sunpharma site no. 11

Greenville, South Carolina, 29601, United States

Location

Sunpharma site no. 09

Lubbock, Texas, 79410, United States

Location

Sunpharma site no. 03

San Antonio, Texas, 78229, United States

Location

Sunpharma site no. 01

Tomball, Texas, 77375, United States

Location

Sunpharma site no. 06

Spokane, Washington, 99204, United States

Location

Sunpharma Site 39

Phillip, Australian Capital Territory, 2606, Australia

Location

Sunpharma site no. 08

Hobart, Tasmania, 7000, Australia

Location

Sunpharma Site 64

Brno, 638 00, Czechia

Location

Sunpharma Site 97

Prague, 12800, Czechia

Location

Sunpharma Site 63

Zlín, 760 01, Czechia

Location

Sunpharma Site 73

Berlin, 12161, Germany

Location

Sunpharma Site 92

Herne, 44649, Germany

Location

Sunpharma Site 111

Surat, Gujarat, 395010, India

Location

Sunpharma Site 110

Bangalore, Karnataka, 560079, India

Location

Sunpharma Site 107

Belagavi, Karnataka, 590016, India

Location

Sunpharma Site 109

Hubli, Karnataka, 580021, India

Location

Sunpharma Site 108

Pune, Maharashtra, 411004, India

Location

Sunpharma Site 112

Hyderabad, Telangana, 500003, India

Location

Sunpharma Site 106

Lucknow, Uttar Pradesh, 226003, India

Location

Sunpharma Site 113

Kochi, 682040, India

Location

Sunpharma Site 84

Nagoya, Aichi-ken, 467-0001, Japan

Location

Sunpharma Site 89

Kitakyushu, Fukuoka, 802-8561, Japan

Location

Sunpharma Site 86

Sendai, Miyagi, 980-8574, Japan

Location

Sunpharma Site 24

Miyazaki, Miyazaki, 889-1692, Japan

Location

Sunpharma Site 91

Mitaka, Tokyo, 181-8611, Japan

Location

Sunpharma Site 85

Shinjuku, Tokyo, 160-0023, Japan

Location

Sunpharma Site 90

tabashi City, Tokyo, 173-8606, Japan

Location

Sunpharma Site 22

Kitakyushu-shi, 802-8561, Japan

Location

Sunpharma Site 88

Kumamoto, 860-8556, Japan

Location

Sunpharma Site 87

Osaka, 545-0051, Japan

Location

Sunpharma Site 23

Tsu, 514-8507, Japan

Location

Sunpharma Site 93

Bialystok, 15-351, Poland

Location

Sunpharma Site 95

Bialystok, 15-879, Poland

Location

Sunpharma Site 94

Lublin, 20-607, Poland

Location

Sunpharma Site 74

Poznan, 61-113, Poland

Location

Sunpharma Site 96

Warsaw, 02-118, Poland

Location

Sunpharma Site 18

Incheon, 22332, South Korea

Location

Sunpharma Site 20

Seoul, 3080, South Korea

Location

Sunpharma Site 19

Seoul, 4763, South Korea

Location

Sunpharma Site 75

A Coruña, 15006, Spain

Location

Sunpharma Site 71

Córdoba, 14004, Spain

Location

Sunpharma Site 100

Madrid, 28046, Spain

Location

Sunpharma Site 72

Seville, 41013, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 19, 2020
• Study Start: July 1, 2020
• Primary Completion: June 4, 2025
• Study Completion: April 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); ES (4); AU (2); KR (3); JP (11); CZ (3); US (11); PL (5); IN (8)