Phase 2
N=391
Efficacy and Safety Study of SUNPG1623
Active Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02980692 ↗Enrolled (actual)
391
Serious AEs
1.8%
Results posted
May 2021
Primary outcome: Primary: Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate — 0.7949; 0.7722; 0.7143; 0.7308 proportion of subjects — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SUNPG1623 I (Drug); SUNPG1623 II (Drug); SUNPG1623 III (Drug); SUNPG1623 IV (Drug); PLACEBO (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate |
0.9254; 0.8906; 0.8667; 0.8133; 0.8133 | — |
| SECONDARY Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate |
0.9254; 0.8906; 0.8667; 0.8133; 0.8133 | — |
| SECONDARY Proportion of Subjects Achieving American College of Rheumatology50 Response Rate |
0; 0.0253; 0.0130; 0.0128; 0; 0.0256 | — |
| SECONDARY Proportion of Subjects Achieving American College of Rheumatology70 Response Rate |
0; 0.0127; 0; 0; 0; 0.0128 | — |
| SECONDARY Change From Baseline in Tender Joint Counts |
-12.3; -13.7; -16.0; -14.0; -13.9 | — |
| SECONDARY Change From Baseline in Tender Joint Counts |
-12.3; -13.7; -16.0; -14.0; -13.9 | — |
| SECONDARY Change From Baseline in Swollen Joint Counts |
-8.7; -7.5; -9.2; -7.5; -9.0 | — |
| SECONDARY Change From Baseline in Swollen Joint Counts |
-8.7; -7.5; -9.2; -7.5; -9.0 | — |
| SECONDARY Physician Global Assessment of Disease Activity Visual Analog Scale |
-7.8; -8.0; -7.2; -6.2; -4.5; -14.3 | <.0001 sig |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale |
-40.0; -44.3; -45.3; -42.7; -42.0 | — |
| SECONDARY Patient's Global Assessment of Disease Activity |
-5.9; -7.5; -6.8; -6.4; -2.8; -7.5 | 0.0003 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity |
-42.2; -43.8; -38.4; -37.9; -40.5 | — |
| SECONDARY Patient's Pain Assessment |
-5.8; -8.1; -5.1; -5.8; -1.6; -9.8 | 0.0003 sig |
| SECONDARY Change From Baseline in Patient's Pain Assessment |
-40.7; -42.7; -38.0; -37.6; -41.0 | — |
| SECONDARY Health Assessment Questionnaire- Disability Index |
-0.0374; -0.0453; -0.0552; -0.0411; -0.0045; -0.0025 | 0.0987 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index |
-0.4869; -0.5430; -0.4857; -0.4583; -0.4700 | — |
| SECONDARY Acute Phase C - Reactive Protein |
-3.43; -3.68; -6.05; -4.61; -6.75 | — |
| SECONDARY Acute Phase C - Reactive Protein |
-3.43; -3.68; -6.05; -4.61; -6.75 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
-3.1; -3.0; -3.3; -1.1; -2.6; -6.9 | 0.0351 sig |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate |
-7.2; -7.2; -8.9; -9.7; -9.2 | — |
| SECONDARY The Proportion of Subjects Who Require Adjustment of Background Therapy |
0; 0.0127; 0.0130; 0.0256; 0.0127 | — |
| SECONDARY Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate |
11.54; 12.66; 10.39; 5.13; 6.33; 20.51 | — |
| SECONDARY Minimal Disease Activity |
0; 1.27; 0; 0; 0; 3.85 | — |
| SECONDARY Change From Baseline in Leeds Dactylitis Index (LDI) |
-14.453; -18.883; -27.084; -26.173; -50.399 | — |
| SECONDARY Change From Baseline in Leeds Dactylitis Index (LDI) |
-14.453; -18.883; -27.084; -26.173; -50.399 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index (LEI) |
-1.3; -1.0; -1.7; -1.2; -1.2 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index (LEI) |
-1.3; -1.0; -1.7; -1.2; -1.2 | — |
Summary
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02980692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.