Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
- Conditions
- Active Psoriatic Arthritis
- Interventions
- Drug: matching placebo injectionsDrug: TILD
- Registration Number
- NCT04314531
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 296
- 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.
-
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.
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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.
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Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
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Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
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Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
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Subjects with a history of alcohol or drug abuse in the previous 2 years.
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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.
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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).
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Subject previously has been enrolled (randomized) in this study.
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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.
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Donation or loss of 400 milliliter (mL) or more of blood within 8 weeks before first dose of IMP.
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Subjects who have been placed in an institution on official or judicial orders.
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Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B matching placebo injections - Arm A TILD -
- Primary Outcome Measures
Name Time Method The proportion of subjects who achieve American College of Rheumatology [ACR20] at Week 24 the proportion of subjects achieving a 20% reduction from Baseline in response criteria
- Secondary Outcome Measures
Name Time Method Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score at Week 24 The change from Baseline in the van der Heijde modified total Sharp score at Week 16 In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3% those with involvement of nails, the change from Baseline in nail psoriasis severity index at Week 52 In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis at week 52 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 American College of Rheumatology Response Criteria Components Score at Week 24 Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and erythrocyte sedimentation rate levels
The change from Baseline in Leeds Dactylitis Index at Week 24 The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2 at Week 24 The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5 Week 24 The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5 at Week 52 The proportion of subjects achieving American College of Rheumatology [ACR50] at Week 24 the proportion of subjects achieving a 50% reduction from Baseline in response criteria
The proportion of subjects achieving American College of Rheumatology [ACR70] at Week 24 the proportion of subjects achieving a 70% reduction from Baseline in response criteria
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2 at Week 52 The change from Baseline in Leeds Enthesitis Index at Week 24 The proportion of subjects with active Psoriasis and body surface area ≥3% at Week 24 Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index at Week 52 The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score at Week 52 The change from Baseline in van der Heijde modified total Sharp score at Week 52 The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components measured timepoints The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores at week 24 The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index at Week 24 The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) at Week 52 The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥ 3% (those with involvement of nails) at Week 24 Physician Global Assessment-Psoriasis and nail psoriasis severity index
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70] at Week 52 the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria
The change from Baseline in American College of Rheumatology Response Criteria Components Score at week 52 Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and erythrocyte sedimentation rate levels
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the proportion of subjects with Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100 at Week 52
Trial Locations
- Locations (54)
Sunpharma site no. 12
🇺🇸Covina, California, United States
Sunpharma site no. 04
🇺🇸Miami Beach, Florida, United States
Sunpharma site no. 02
🇺🇸New Port Richey, Florida, United States
Sunpharma site no. 07
🇺🇸Tamarac, Florida, United States
Sunpharma site no. 14
🇺🇸Lake Charles, Louisiana, United States
Sunpharma site no. 05
🇺🇸Springfield, Missouri, United States
Sunpharma site no. 10
🇺🇸Lincoln, Nebraska, United States
Sunpharma site no. 11
🇺🇸Greenville, South Carolina, United States
Sunpharma site no. 09
🇺🇸Lubbock, Texas, United States
Sunpharma site no. 03
🇺🇸San Antonio, Texas, United States
Sunpharma site no. 01
🇺🇸Tomball, Texas, United States
Sunpharma site no. 06
🇺🇸Spokane, Washington, United States
Sunpharma Site 39
🇦🇺Phillip, Australian Capital Territory, Australia
Sunpharma Site 16
🇦🇺Maroochydore, Queensland, Australia
Sunpharma site no. 08
🇦🇺Hobart, Tasmania, Australia
Sunpharma Site 101
🇦🇺Fitzroy, Victoria, Australia
Sunpharma Site 64
🇨🇿Brno, Czechia
Sunpharma Site 97
🇨🇿Prague 2, Czechia
Sunpharma Site 102
🇨🇿Praha 4, Czechia
Sunpharma Site 63
🇨🇿Zlín, Czechia
Sunpharma Site 73
🇩🇪Berlin, Germany
Sunpharma Site 92
🇩🇪Herne, Germany
Sunpharma Site 111
🇮🇳Surat, Gujarat, India
Sunpharma Site 110
🇮🇳Bangalore, Karnataka, India
Sunpharma Site 107
🇮🇳Belgaum, Karnataka, India
Sunpharma Site 109
🇮🇳Hubli, Karnataka, India
Sunpharma Site 108
🇮🇳Pune, Maharashtra, India
Sunpharma Site 112
🇮🇳Hyderabad, Telangana, India
Sunpharma Site 106
🇮🇳Lucknow, Uttar Pradesh, India
Sunpharma Site 113
🇮🇳Cochin, India
Sunpharma Site 84
🇯🇵Nagoya, Aichi, Japan
Sunpharma Site 89
🇯🇵Kitakyushu, Fukuoka, Japan
Sunpharma Site 86
🇯🇵Sendai, Miyagi, Japan
Sunpharma Site 24
🇯🇵Miyazaki-shi, Miyazaki, Japan
Sunpharma Site 90
🇯🇵Itabashi, Tokyo, Japan
Sunpharma Site 91
🇯🇵Mitaka, Tokyo, Japan
Sunpharma Site 85
🇯🇵Shinjuku, Tokyo, Japan
Sunpharma Site 22
🇯🇵Kitakyushu-shi, Japan
Sunpharma Site 88
🇯🇵Kumamoto, Japan
Sunpharma Site 87
🇯🇵Osaka, Japan
Sunpharma Site 23
🇯🇵Tsu-shi, Japan
Sunpharma Site 18
🇰🇷Incheon, Korea, Republic of
Sunpharma Site 20
🇰🇷Seoul, Korea, Republic of
Sunpharma Site 19
🇰🇷Seoul, Korea, Republic of
Sunpharma Site 95
🇵🇱Bialystok, Poland
Sunpharma Site 93
🇵🇱Białystok, Poland
Sunpharma Site 94
🇵🇱Lublin, Poland
Sunpharma Site 74
🇵🇱Poznan, Poland
Sunpharma Site 96
🇵🇱Warszawa, Poland
Sunpharma Site 71
🇪🇸Córdoba, Spain
Sunpharma Site 75
🇪🇸La Coruña, Spain
Sunpharma Site 100
🇪🇸Madrid, Spain
Sunpharma Site 72
🇪🇸Sevilla, Spain
Sunpharma Site 76
🇪🇸Valencia, Spain