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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 : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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)

Condition or disease Intervention/treatment Phase
Active Psoriatic Arthritis Drug: TILD Drug: matching placebo injections Phase 3

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Study Type : Interventional
Estimated Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 11, 2021
Estimated Study Completion Date : August 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A Drug: TILD
one 1 mL injection of study medication

Placebo Comparator: Arm B Drug: matching placebo injections
one 1 mL injection of placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]
  4. The change from Baseline in the van der Heijde modified total Sharp score [ Time Frame: at Week 24 ]
  5. The change from Baseline in the van der Heijde modified total Sharp score [ Time Frame: at Week 16 ]
  6. 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

  7. change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: at Week 24 ]
  8. change from Baseline in Leeds Enthesitis Index [ Time Frame: at Week 24 ]
  9. The change from Baseline in Leeds Dactylitis Index [ Time Frame: at Week 24 ]
  10. The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2 [ Time Frame: at Week 24 ]
  11. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [ Time Frame: at Week 24 ]
  12. The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 [ Time Frame: at Week 24. ]
  13. 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

  14. 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

  15. 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

  16. 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

  17. The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: at Week 52 ]
  18. The change from Baseline [ Time Frame: at Week 52 ]
    Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score

  19. The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2 [ Time Frame: at Week 52 ]
  20. The change from Baseline in van der Heijde modified total Sharp score [ Time Frame: at Week 52 ]
  21. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [ Time Frame: at Week 52 ]
  22. The proportion of subjects with the change in van der Heijde modified total Sharp score <0 [ Time Frame: at Week 52 ]
  23. 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

  24. 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 ]
  25. In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis [ Time Frame: at Week 52 ]

Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2 [ Time Frame: Weeks 24 and 52 ]
  7. 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

  8. 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

  9. The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores [ Time Frame: at Week 24 ]
  10. The change from Baseline in the levels of "Metabolic Biomarkers" [ Time Frame: at Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314544


Contacts
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Contact: Head, Clinical development 91 2266455645 clinical.trials@sparcmail.com

Locations
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Sponsors and Collaborators
Sun Pharma Global FZE
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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT04314544    
Other Study ID Numbers: TILD-19-07
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases