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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04314544




Registration number
NCT04314544
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 Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Scientific title
A 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)
Secondary ID [1] 0 0
TILD-19-07
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
at 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
Change from Baseline in American College of Rheumatology Response Criteria Components Score
Timepoint [6] 0 0
at Week 24
Secondary outcome [7] 0 0
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Timepoint [7] 0 0
at Week 24
Secondary outcome [8] 0 0
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
at 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 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
The 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
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 subjects with active Psoriasis and Body surface area =3%, the proportion of subjects
Timepoint [23] 0 0
at Week 52
Secondary outcome [24] 0 0
In 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 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
Weeks 24 and 52
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. RF and anti-CCP Ab negative.
4. Subjects must have prior exposure to 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. Subject has a planned surgical intervention between Baseline and the Week 24 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 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 a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
4. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
5. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
6. 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.
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 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.
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 mL or more of blood within 8 weeks before dosing.
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
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
1/02/2026
Actual
Sample size
Target
472
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Sunpharma Site no. 81 - Phillip
Recruitment hospital [2] 0 0
Sunpharma Site no. 84 - Kogarah
Recruitment hospital [3] 0 0
Sunpharma Site no 68 - Maroochydore
Recruitment hospital [4] 0 0
Sunpharma site no. 24 - Hobart
Recruitment hospital [5] 0 0
Sunpharma Site no 67 - Camberwell
Recruitment hospital [6] 0 0
Sunpharma Site no. 82 - Fitzroy
Recruitment hospital [7] 0 0
Sunpharma Site no. 83 - Murdoch
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
North Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Prague 2
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 4
Country [32] 0 0
Czechia
State/province [32] 0 0
Zlín
Country [33] 0 0
Estonia
State/province [33] 0 0
Tallinn
Country [34] 0 0
Estonia
State/province [34] 0 0
Tallin
Country [35] 0 0
Estonia
State/province [35] 0 0
Tartu
Country [36] 0 0
Germany
State/province [36] 0 0
Bad Doberan
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Herne
Country [39] 0 0
India
State/province [39] 0 0
Chennai
Country [40] 0 0
India
State/province [40] 0 0
Gujarat
Country [41] 0 0
India
State/province [41] 0 0
Karnataka
Country [42] 0 0
India
State/province [42] 0 0
Maharashtra
Country [43] 0 0
India
State/province [43] 0 0
Telangana
Country [44] 0 0
India
State/province [44] 0 0
Uttar Pradesh
Country [45] 0 0
Italy
State/province [45] 0 0
Brescia
Country [46] 0 0
Italy
State/province [46] 0 0
Milan
Country [47] 0 0
Italy
State/province [47] 0 0
Verona
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daejeon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Gyeonggi-do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Incheon
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Poland
State/province [52] 0 0
Mazowiecki
Country [53] 0 0
Poland
State/province [53] 0 0
Bialystok
Country [54] 0 0
Poland
State/province [54] 0 0
Katowice
Country [55] 0 0
Poland
State/province [55] 0 0
Krakow
Country [56] 0 0
Poland
State/province [56] 0 0
Lublin
Country [57] 0 0
Poland
State/province [57] 0 0
Olsztyn
Country [58] 0 0
Poland
State/province [58] 0 0
Ponzan
Country [59] 0 0
Poland
State/province [59] 0 0
Poznan
Country [60] 0 0
Poland
State/province [60] 0 0
Torun
Country [61] 0 0
Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
Poland
State/province [62] 0 0
Wroclaw
Country [63] 0 0
Slovakia
State/province [63] 0 0
Martin
Country [64] 0 0
Slovakia
State/province [64] 0 0
Rimavska Sobota
Country [65] 0 0
Slovakia
State/province [65] 0 0
Svidnik
Country [66] 0 0
Slovakia
State/province [66] 0 0
Vahom
Country [67] 0 0
Spain
State/province [67] 0 0
Córdoba
Country [68] 0 0
Spain
State/province [68] 0 0
Gran Canaria
Country [69] 0 0
Spain
State/province [69] 0 0
La Coruña
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Spain
State/province [71] 0 0
Malaga
Country [72] 0 0
Spain
State/province [72] 0 0
Sabadell
Country [73] 0 0
Spain
State/province [73] 0 0
Santiago de Compostela
Country [74] 0 0
Spain
State/province [74] 0 0
Sevilla
Country [75] 0 0
Spain
State/province [75] 0 0
Valencia
Country [76] 0 0
Taiwan
State/province [76] 0 0
Pai-Tou
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taichung
Country [78] 0 0
Taiwan
State/province [78] 0 0
Hsinchu
Country [79] 0 0
Taiwan
State/province [79] 0 0
Kaohsiung
Country [80] 0 0
Taiwan
State/province [80] 0 0
Tainan
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei

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
Head, Clinical development
Address 0 0
Country 0 0
Phone 0 0
91 2266455645
Fax 0 0
Email 0 0
[email protected]
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/NCT04314544