Efficacy and Safety Study of SUNPG1623

Phase 2

Completed

Conditions: Active Psoriatic Arthritis

Interventions: Drug: PLACEBO
Drug: SUNPG1623 III
Drug: SUNPG1623 II
Drug: SUNPG1623 I
Drug: SUNPG1623 IV

Registration Number: NCT02980692

Lead Sponsor: Sun Pharmaceutical Industries Limited

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 391

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PLACEBO	mid range dose to high dose
SUNPG1623 dose III	PLACEBO	mid range dose
SUNPG1623 dose IV	PLACEBO	mid range dose to high dose
SUNPG1623 dose II	PLACEBO	mid range dose
SUNPG1623 dose III	SUNPG1623 III	mid range dose
SUNPG1623 dose II	SUNPG1623 II	mid range dose
SUNPG1623 dose I	SUNPG1623 I	low range dose
SUNPG1623 dose IV	SUNPG1623 IV	mid range dose to high dose

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate	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. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate	week 52	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.
Proportion of Subjects Achieving American College of Rheumatology50 Response Rate	week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52	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.
Proportion of Subjects Achieving American College of Rheumatology70 Response Rate	week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52	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.
Change From Baseline in Tender Joint Counts	Week 52	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.
Change From Baseline in Swollen Joint Counts	Week 52	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.
Physician Global Assessment of Disease Activity Visual Analog Scale	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)
Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale	Week 52	100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Patient's Global Assessment of Disease Activity	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)
Change From Baseline in Patient's Global Assessment of Disease Activity	Week 52	100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Patient's Pain Assessment	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).
Change From Baseline in Patient's Pain Assessment	Week 52	100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Health Assessment Questionnaire- Disability Index	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
Change From Baseline in Health Assessment Questionnaire- Disability Index	Week 52	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
Acute Phase C - Reactive Protein	Week 52	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.
Erythrocyte Sedimentation Rate	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.
Change From Baseline in Erythrocyte Sedimentation Rate	Week 52	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.
The Proportion of Subjects Who Require Adjustment of Background Therapy	Week 16
Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate	week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52	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
Minimal Disease Activity	week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52	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.
Change From Baseline in Leeds Dactylitis Index (LDI)	Week 52	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.
Change From Baseline in Leeds Enthesitis Index (LEI)	Week 52	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