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

NCT04314544 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: TILD-19-07
• Study Type: interventional
• Target: 508
• Locations: 11 countries
• Sites: 89

Brief 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)

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

  at 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]

  Weeks 24 and 52

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

  Weeks 24 and 52

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

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

You may not qualify if:

• 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:
• 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 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 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.
• 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 mL or more of blood within 8 weeks before dosing.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (97)

Sunpharma Site no 42

Dothan, Alabama, 36305, United States

Location

Sunpharma Site no 29

Gilbert, Arizona, 85297, United States

Location

Sunpharma Site no 30

Glendale, Arizona, 85306, United States

Location

Sunpharma Site no 31

Mesa, Arizona, 85210, United States

Location

Sunpharma Site no 35

Covina, California, 91722, United States

Location

Sunpharma Site no 48

Encino, California, 91436, United States

Location

Sunpharma site no. 17

Fountain Valley, California, 92708, United States

Location

Sunpharma site no. 15

Thousand Oaks, California, 91320, United States

Location

Sunpharma Site no. 141

Avon Park, Florida, 33825, United States

Location

Sunpharma site no. 21

Clearwater, Florida, 33765, United States

Location

Sunpharma site no. 02

Hialeah, Florida, 33016, United States

Location

Sunpharma Site no 55

Kissimmee, Florida, 34741, United States

Location

Sunpharma Site no. 75

Margate, Florida, 33063, United States

Location

Sunpharma site no. 05

New Port Richey, Florida, 34652, United States

Location

Sunpharma Site no. 76

Ocoee, Florida, 34761, United States

Location

SunPharma Site no 22

Tamarac, Florida, 33321, United States

Location

Sunpharma Site no 46

Gainesville, Georgia, 30501, United States

Location

Sunpharma Site no 41

Oak Brook, Illinois, 60523, United States

Location

Sunpharma Site no 54

Orland Park, Illinois, 60467, United States

Location

Sunpharma Site no 38

Schaumburg, Illinois, 60185, United States

Location

Sunpharma Site no 37

Skokie, Illinois, 60076, United States

Location

Sunpharma Site no. 122

Skokie, Illinois, 60077, United States

Location

Sunpharma site no. 20

Wichita, Kansas, 67207, United States

Location

Sunpharma site no. 07

Worcester, Massachusetts, 01605, United States

Location

Sunpharma site no. 14

Springfield, Missouri, 65810, United States

Location

Sunpharma Site no 53

Kalispell, Montana, 59901, United States

Location

Sunpharma Site no 27

Lincoln, Nebraska, 68516, United States

Location

Sunpharma Site no 44

Voorhees Township, New Jersey, 08043, United States

Location

Sunpharma Site no 52

Charlotte, North Carolina, 28204, United States

Location

Sunpharma Site no. 73

Leland, North Carolina, 28451, United States

Location

Sunpharma Site no 56

Wilmington, North Carolina, 28401, United States

Location

Sunpharma Site no 33

Minot, North Dakota, 58701, United States

Location

Sunpharma site no. 11

Middleburg Heights, Ohio, 44130, United States

Location

Sunpharma Site no. 124

Oklahoma City, Oklahoma, 73103, United States

Location

Sunpharma Site no 34

Greenville, South Carolina, 29601, United States

Location

Sunpharma Site no 50

Austin, Texas, 78745, United States

Location

Sunpharma site no. 13

Baytown, Texas, 77521, United States

Location

Sunpharma Site no 49

Colleyville, Texas, 76034, United States

Location

Sunpharma site no. 08

Houston, Texas, 77084, United States

Location

Sunpharma Site no 28

Lubbock, Texas, 79410, United States

Location

Sunpharma Site no. 74

Mesquite, Texas, 75150, United States

Location

Sunpharma site no. 16

San Antonio, Texas, 78229, United States

Location

Sunpharma Site no 26

Stafford, Texas, 77477, United States

Location

Sunpharma site no. 01

Tomball, Texas, 77375, United States

Location

Sunpharma Site no. 121

Salt Lake City, Utah, 84132, United States

Location

Sunpharma site 98

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Sun pharma site 99

Brno, 63800, Czechia

Location

Sunpharma Site no. 100

Prague, 12800, Czechia

Location

Sunpharma Site no. 101

Prague, 14000, Czechia

Location

Sunpharma Site no. 96

Zlín, 760 01, Czechia

Location

Sunpharma Site no. 85

Tallinn, 10117, Estonia

Location

Sunpharma Site no. 87

Tartu, 50106, Estonia

Location

Sunpharma Site no. 86

Tartu, 50708, Estonia

Location

Sunpharma Site no. 91

Berlin, 12161, Germany

Location

Sunpharma Site no. 103

Herne, 44649, Germany

Location

Sunpharma Site no. 128

Mylapore, Chennai, 600004, India

Location

Sunpharma Site no. 134

Surat, Gujarat, 395010, India

Location

Sunpharma Site no. 127

Bangalore, Karnataka, 560079, India

Location

Sunpharma Site no. 130

Belagavi, Karnataka, 590016, India

Location

Sunpharma Site no. 132

Hubli, Karnataka, 580021, India

Location

Sunpharma Site no. 143

Kochi, Kerala, 682040, India

Location

Sunpharma Site no. 131

Pune, Maharashtra, 411004, India

Location

Sunpharma Site no. 142

Pune, Maharashtra, 411014, India

Location

Sunpharma Site no. 129

Lucknow, Uttar Pradesh, 226003, India

Location

Sunpharma Site no. 144

Kolkata, West Bengal, 700020, India

Location

Sunpharma Site no. 104

Milan, 20089, Italy

Location

Sunpharma Site no. 138

Verona, 37134, Italy

Location

Sunpharma Site no. 95

Warsaw, Mazowiecki, 05-830, Poland

Location

Sunpharma Site no. 110

Bialystok, 15-351, Poland

Location

Sunpharma Site no. 93

Bialystok, 15-879, Poland

Location

Sunpharma Site no. 139

Katowice, 40-081, Poland

Location

Sunpharma Site no. 94

Krakow, 30-033, Poland

Location

Sunpharma Site no. 107

Lublin, 20-607, Poland

Location

Sunpharma Site no. 136

Olsztyn, 10-117, Poland

Location

Sunpharma Site no. 106

Ponzan, 60-529, Poland

Location

Sunpharma Site no. 92

Poznan, 61-113, Poland

Location

Sunpharma Site no. 108

Torun, 87-100, Poland

Location

Sunpharma Site no. 111

Warsaw, 02-118, Poland

Location

Sunpharma Site no. 137

Wroclaw, 52-416, Poland

Location

Sunpharma Site no. 88

Martin, 3601, Slovakia

Location

Sunpharma Site no. 112

Vahom, 91501, Slovakia

Location

Sunpharma Site no 71

Seoul, 3080, South Korea

Location

Sunpharma Site no 70

Seoul, 4763, South Korea

Location

Sunpharma Site no 58

A Coruña, 15006, Spain

Location

SunPharma Site No 23

Córdoba, 14004, Spain

Location

Sunpharma Site no. 78

Madrid, 28046, Spain

Location

Sunpharma Site no. 116

Málaga, 29009, Spain

Location

Sunpharma Site no. 125

Sabadell, 8208, Spain

Location

Sunpharma Site no. 115

Santiago de Compostela, 15706, Spain

Location

Sunpharma Site no. 117

Seville, 41014, Spain

Location

Sunpharma Site no 59

Valencia, 46010, Spain

Location

Sunpharma Site no 65

Taipei, Pai-Tou, 112, Taiwan

Location

Sunpharma Site no 63

Jianguo, Taichung, 402, Taiwan

Location

Sunpharma Site no. 79

Hsinchu, 300, Taiwan

Location

Sunpharma Site no 62

Kaohsiung City, 833, Taiwan

Location

Sunpharma Site no 60

Tainan, 710, Taiwan

Location

Sunpharma Site no 64

Taipei, 112, Taiwan

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: March 26, 2025
• Study Completion: December 22, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (10); CA (1); TW (6); PL (12); US (45); SL (2); CZ (4); DE (2); IT (2); KR (2); ES (3)