This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
391
SPARC Site 1
Middleburg Heights, Ohio, United States
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
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. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time frame: week 24
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
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. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time frame: week 52
Proportion of Subjects Achieving American College of Rheumatology50 Response Rate
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. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Proportion of Subjects Achieving American College of Rheumatology70 Response Rate
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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. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52
Change From Baseline in Tender Joint Counts
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Tender Joint Counts
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.
Time frame: Week 52
Change From Baseline in Swollen Joint Counts
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Swollen Joint Counts
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.
Time frame: Week 52
Physician Global Assessment of Disease Activity Visual Analog Scale
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Time frame: Week 52
Patient's Global Assessment of Disease Activity
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Time frame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24
Change From Baseline in Patient's Global Assessment of Disease Activity
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Time frame: Week 52
Patient's Pain Assessment
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Patient's Pain Assessment
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Time frame: Week 52
Health Assessment Questionnaire- Disability Index
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Health Assessment Questionnaire- Disability Index
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
Time frame: Week 52
Acute Phase C - Reactive Protein
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Acute Phase C - Reactive Protein
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. Change from Baseline in C-Reactive Protein.
Time frame: Week 52
Erythrocyte Sedimentation Rate
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Change From Baseline in Erythrocyte Sedimentation Rate
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.
Time frame: Week 52
The Proportion of Subjects Who Require Adjustment of Background Therapy
Time frame: Week 16
Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52
Minimal Disease Activity
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Change From Baseline in Leeds Dactylitis Index (LDI)
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.
Time frame: week 4, week 12, and week 24
Change From Baseline in Leeds Dactylitis Index (LDI)
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.
Time frame: Week 52
Change From Baseline in Leeds Enthesitis Index (LEI)
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
Time frame: week 4, week 12 and week 24
Change From Baseline in Leeds Enthesitis Index (LEI)
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
Time frame: Week 52