Clinical trial NCT02980692: Efficacy and Safety Study of SUNPG1623
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Psoriatic Arthritis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
timeFrame: week 24
Secondary outcomes:
measure: Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
timeFrame: week 52
measure: Proportion of Subjects Achieving American College of Rheumatology50 Response Rate
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
measure: Proportion of Subjects Achieving American College of Rheumatology70 Response Rate
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52
measure: Change From Baseline in Tender Joint Counts
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Tender Joint Counts
timeFrame: Week 52
measure: Change From Baseline in Swollen Joint Counts
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Swollen Joint Counts
timeFrame: Week 52
measure: Physician Global Assessment of Disease Activity Visual Analog Scale
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale
timeFrame: Week 52
measure: Patient's Global Assessment of Disease Activity
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20 and week 24
measure: Change From Baseline in Patient's Global Assessment of Disease Activity
timeFrame: Week 52
measure: Patient's Pain Assessment
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Patient's Pain Assessment
timeFrame: Week 52
measure: Health Assessment Questionnaire- Disability Index
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index
timeFrame: Week 52
measure: Acute Phase C - Reactive Protein
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Acute Phase C - Reactive Protein
timeFrame: Week 52
measure: Erythrocyte Sedimentation Rate
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
measure: Change From Baseline in Erythrocyte Sedimentation Rate
timeFrame: Week 52
measure: The Proportion of Subjects Who Require Adjustment of Background Therapy
timeFrame: Week 16
measure: Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52
measure: Minimal Disease Activity
timeFrame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
measure: Change From Baseline in Leeds Dactylitis Index (LDI)
timeFrame: week 4, week 12, and week 24
measure: Change From Baseline in Leeds Dactylitis Index (LDI)
timeFrame: Week 52
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
timeFrame: week 4, week 12 and week 24
measure: Change From Baseline in Leeds Enthesitis Index (LEI)
timeFrame: Week 52
Other outcomes:
Locations:
city: Middleburg Heights
country: United States
facility: SPARC Site 1
state: Ohio
Study officials:
References:
citation: Mease PJ, Chohan S, Fructuoso FJG, Luggen ME, Rahman P, Raychaudhuri SP, Chou RC, Mendelsohn AM, Rozzo SJ, Gottlieb A. Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study. Ann Rheum Dis. 2021 Sep;80(9):1147-1157. doi: 10.1136/annrheumdis-2020-219014. Epub 2021 May 13.