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

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ClinicalTrials.gov Identifier: NCT04314544
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Tracking Information
First Submitted Date  ICMJE March 13, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
The proportion of subjects who achieve American College of Rheumatology [ACR20] [ Time Frame: at week 24 ]
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • The proportion of subjects achieving American College of Rheumatology [ACR50] [ Time Frame: 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] [ Time Frame: at Week 24 ]
    the proportion of subjects achieving a 70% reduction from Baseline in response criteria
  • The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline [ Time Frame: at Weeks 24 ]
  • The change from Baseline in the van der Heijde modified total Sharp score [ Time Frame: at Week 24 ]
  • The change from Baseline in the van der Heijde modified total Sharp score [ Time Frame: at Week 16 ]
  • Change from Baseline in American College of Rheumatology Response Criteria Components Score [ Time Frame: at Week 24 ]
    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 1-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
  • change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: at Week 24 ]
  • change from Baseline in Leeds Enthesitis Index [ Time Frame: at Week 24 ]
  • The change from Baseline in Leeds Dactylitis Index [ Time Frame: at Week 24 ]
  • The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2 [ Time Frame: at Week 24 ]
  • The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [ Time Frame: at Week 24 ]
  • The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 [ Time Frame: at Week 24. ]
  • The change from baseline in Health Assessment Questionnaire Disability Index at Week 24. The proportion of subjects with active Psoriasis and Body surface area ≥3% [ Time Frame: at Week 24 ]
    with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
  • The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% [ Time Frame: 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] [ Time Frame: 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 [ Time Frame: at Week 52 ]
    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 1-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
  • The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: at Week 52 ]
  • The change from Baseline [ Time Frame: at Week 52 ]
    Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score
  • The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2 [ Time Frame: at Week 52 ]
  • The change from Baseline in van der Heijde modified total Sharp score [ Time Frame: at Week 52 ]
  • The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [ Time Frame: at Week 52 ]
  • The proportion of subjects with the change in van der Heijde modified total Sharp score <0 [ Time Frame: at Week 52 ]
  • In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects [ Time Frame: at Week 52 ]
    Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
  • In subjects with active Psoriasis and Body surface area ≥3% Psoriatic arthritis, the change from Baseline in nail psoriasis severity index [ Time Frame: at Week 52 ]
  • In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis [ Time Frame: at Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 17, 2020)
  • The proportion of subjects achieving American College of Rheumatology [ACR20] [ Time Frame: Weeks 24 and 52 ]
    the proportion of subjects achieving a 20% reduction from Baseline in response criteria
  • The proportion of subjects achieving American College of Rheumatology [ACR50] [ Time Frame: Weeks 24 and 52 ]
    the proportion of subjects achieving a 50% reduction from Baseline in response criteria
  • The proportion of subjects achieving American College of Rheumatology [ACR70] [ Time Frame: Weeks 24 and 52 ]
    the proportion of subjects achieving a 70% reduction from Baseline in response criteria
  • The change from Baseline in American College of Rheumatology Response Criteria Components Score [ Time Frame: Weeks 24 and 52 ]
    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 1-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 1-100), C-reactive protein levels and Erythrocyte sedimentation rate levels
  • The change from Baseline [ Time Frame: Weeks 24 and 52 ]
    Leeds Enthesitis Index, Leeds Dactylitis Index, Bath Ankylosing Spondylitis Disease Activity Index and Health Assessment Questionnaire Disability Index score
  • The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2 [ Time Frame: Weeks 24 and 52 ]
  • The proportion of subjects with active Psoriasis and Body surface area ≥ 3% [ Time Frame: Weeks 24 and 52 ]
    Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
  • The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components [ Time Frame: Weeks 24 and 52 ]
    Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score
  • The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores [ Time Frame: at Week 24 ]
  • The change from Baseline in the levels of "Metabolic Biomarkers" [ Time Frame: at Week 24 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Active Psoriatic Arthritis
Intervention  ICMJE
  • Drug: TILD
    one 1 mL injection of study medication
  • Drug: matching placebo injections
    one 1 mL injection of placebo
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: TILD
  • Placebo Comparator: Arm B
    Intervention: Drug: matching placebo injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
472
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
200
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Head, Clinical development 91 2266455645 clinical.trials@sparcmail.com
Listed Location Countries  ICMJE Australia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04314544
Other Study ID Numbers  ICMJE TILD-19-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sun Pharma Global FZE
Study Sponsor  ICMJE Sun Pharma Global FZE
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Global FZE
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP