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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04314531




Registration number
NCT04314531
Ethics application status
Date submitted
13/03/2020
Date registered
19/03/2020

Titles & IDs
Public title
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
Secondary ID [1] 0 0
TILD-19-19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TILD
Treatment: Drugs - matching placebo injections

Experimental: Arm A -

Placebo comparator: Arm B -


Treatment: Drugs: TILD
one 1 mL injection of study medication

Treatment: Drugs: matching placebo injections
one 1 mL injection of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of subjects who achieve American College of Rheumatology [ACR20]
Timepoint [1] 0 0
at Week 24
Secondary outcome [1] 0 0
The proportion of subjects achieving American College of Rheumatology [ACR50]
Timepoint [1] 0 0
at Week 24
Secondary outcome [2] 0 0
The proportion of subjects achieving American College of Rheumatology [ACR70]
Timepoint [2] 0 0
at Week 24
Secondary outcome [3] 0 0
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with body surface area =3% at baseline
Timepoint [3] 0 0
at Weeks 24
Secondary outcome [4] 0 0
The change from Baseline in the van der Heijde modified total Sharp score
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
The change from Baseline in the van der Heijde modified total Sharp score
Timepoint [5] 0 0
at Week 16
Secondary outcome [6] 0 0
The Change from Baseline in American College of Rheumatology Response Criteria Components Score
Timepoint [6] 0 0
at Week 24
Secondary outcome [7] 0 0
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Timepoint [7] 0 0
at Week 24
Secondary outcome [8] 0 0
The change from Baseline in Leeds Enthesitis Index
Timepoint [8] 0 0
at Week 24
Secondary outcome [9] 0 0
The change from Baseline in Leeds Dactylitis Index
Timepoint [9] 0 0
at Week 24
Secondary outcome [10] 0 0
The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2
Timepoint [10] 0 0
at Week 24
Secondary outcome [11] 0 0
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Timepoint [11] 0 0
at Week 24
Secondary outcome [12] 0 0
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
The proportion of subjects with active Psoriasis and body surface area =3%
Timepoint [13] 0 0
at Week 24
Secondary outcome [14] 0 0
The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area = 3% (those with involvement of nails)
Timepoint [14] 0 0
at Week 24
Secondary outcome [15] 0 0
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
Timepoint [15] 0 0
at Week 52
Secondary outcome [16] 0 0
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Timepoint [16] 0 0
at week 52
Secondary outcome [17] 0 0
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Timepoint [17] 0 0
at Week 52
Secondary outcome [18] 0 0
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score
Timepoint [18] 0 0
at Week 52
Secondary outcome [19] 0 0
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
Timepoint [19] 0 0
at Week 52
Secondary outcome [20] 0 0
The change from Baseline in van der Heijde modified total Sharp score
Timepoint [20] 0 0
at Week 52
Secondary outcome [21] 0 0
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Timepoint [21] 0 0
at Week 52
Secondary outcome [22] 0 0
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
Timepoint [22] 0 0
at Week 52
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
at Week 52
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
at Week 52
Secondary outcome [25] 0 0
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area =3%, the change from Baseline in Physician Global Assessment-Psoriasis
Timepoint [25] 0 0
at week 52
Secondary outcome [26] 0 0
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
Timepoint [26] 0 0
at Week 24
Secondary outcome [27] 0 0
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Timepoint [27] 0 0
measured timepoints
Secondary outcome [28] 0 0
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
Timepoint [28] 0 0
at week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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.
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
ACT,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Sunpharma Site 39 - Phillip
Recruitment hospital [2] 0 0
Sunpharma Site 16 - Maroochydore
Recruitment hospital [3] 0 0
Sunpharma site no. 08 - Hobart
Recruitment hospital [4] 0 0
Sunpharma Site 101 - Fitzroy
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Czechia
State/province [9] 0 0
Brno
Country [10] 0 0
Czechia
State/province [10] 0 0
Prague 2
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 4
Country [12] 0 0
Czechia
State/province [12] 0 0
Zlín
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Herne
Country [15] 0 0
India
State/province [15] 0 0
Gujarat
Country [16] 0 0
India
State/province [16] 0 0
Karnataka
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
India
State/province [18] 0 0
Telangana
Country [19] 0 0
India
State/province [19] 0 0
Uttar Pradesh
Country [20] 0 0
India
State/province [20] 0 0
Cochin
Country [21] 0 0
Japan
State/province [21] 0 0
Aichi
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Miyagi
Country [24] 0 0
Japan
State/province [24] 0 0
Miyazaki
Country [25] 0 0
Japan
State/province [25] 0 0
Tokyo
Country [26] 0 0
Japan
State/province [26] 0 0
Kitakyushu-shi
Country [27] 0 0
Japan
State/province [27] 0 0
Kumamoto
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tsu-shi
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Incheon
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Lublin
Country [34] 0 0
Poland
State/province [34] 0 0
Poznan
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Spain
State/province [36] 0 0
Córdoba
Country [37] 0 0
Spain
State/province [37] 0 0
La Coruña
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sun Pharmaceutical Industries Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04314531