Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of SUNPG1623

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980692
Recruitment Status : Completed
First Posted : December 2, 2016
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623

Condition or disease Intervention/treatment Phase
Active Psoriatic Arthritis Drug: SUNPG1623 I Drug: SUNPG1623 II Drug: SUNPG1623 III Drug: SUNPG1623 IV Drug: PLACEBO Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SUNPG1623 dose I
low range dose
Drug: SUNPG1623 I
injection

Experimental: SUNPG1623 dose II
mid range dose
Drug: SUNPG1623 II
injection

Drug: PLACEBO
injection

Experimental: SUNPG1623 dose III
mid range dose
Drug: SUNPG1623 III
injection

Drug: PLACEBO
injection

Experimental: SUNPG1623 dose IV
mid range dose to high dose
Drug: SUNPG1623 IV
injection

Drug: PLACEBO
injection

Placebo Comparator: Placebo
mid range dose to high dose
Drug: PLACEBO
injection




Primary Outcome Measures :
  1. Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 ]
    The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.


Secondary Outcome Measures :
  1. Proportion of Subjects Achieving American College of Rheumatology50 Response Rate [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

  2. Proportion of Subjects Achieving American College of Rheumatology70 Response Rate [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.

  3. Change From Baseline in Tender Joint Counts [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

  4. Change From Baseline in Swollen Joint Counts [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.

  5. Physician Global Assessment of Disease Activity Visual Analog Scale [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)

  6. Patient's Global Assessment of Disease Activity [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24 ]
    100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)

  7. Patient's Pain Assessment [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).

  8. Health Assessment Questionnaire- Disability Index [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]

    eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).

    The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability


  9. Acute Phase C - Reactive Protein [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]

    C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.

    CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation


  10. Erythrocyte Sedimentation Rate [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]
    An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.

  11. The Proportion of Subjects Who Require Adjustment of Background Therapy [ Time Frame: Week 16 ]
  12. Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]

    The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).

    DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health


  13. Minimal Disease Activity [ Time Frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24 ]

    A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:

    1. tender joint count ≤1;
    2. swollen joint count ≤1;
    3. PASI score ≤1 or BSA ≤3%;
    4. patient Arthritis Pain (VAS)

      ≤15 mm;

    5. patient's global arthritis assessment (VAS) ≤20 mm;
    6. HAQ-DI score ≤0.5;
    7. tender entheseal points (using LEI) ≤1.

  14. Change From Baseline in Leeds Dactylitis Index (LDI) [ Time Frame: week 4, week 12, and week 24 ]

    tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)

    Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score

    Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45

    The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.

    Lower Leeds Dactylitis Index score represent better outcome.


  15. Change From Baseline in Leeds Enthesitis Index (LEI) [ Time Frame: week 4, week 12 and week 24 ]

    The LEI examines tenderness at 6 sites:

    2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.

    Lower the score better is the outcome




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.


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

Inclusion Criteria:

  • Subject has provided written informed consent
  • Subject is ≥ 18 years of age at time of Screening
  • Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP
  • Subject has a negative evaluation for TB within 4 weeks before initiating IMP
  • Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR] criteria) with symptoms present for at least 6 months.
  • Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

Exclusion Criteria:

  • Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition
  • Subject has an active infection or history of infections
  • Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease
  • Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus

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): NCT02980692


Locations
Layout table for location information
United States, Ohio
SPARC Site 1
Middleburg Heights, Ohio, United States, 44130
Sponsors and Collaborators
Sun Pharma Global FZE
  Study Documents (Full-Text)

Documents provided by Sun Pharma Global FZE:
Study Protocol  [PDF] March 16, 2018
Statistical Analysis Plan  [PDF] October 10, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02980692    
Other Study ID Numbers: CLR_16_23
First Posted: December 2, 2016    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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