Efficacy and Safety Study of SUNPG1623

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

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

Study Overview

• Status: Completed
• Conditions: Active Psoriatic Arthritis
• Intervention / Treatment: Drug: SUNPG1623 I; Drug: SUNPG1623 II; Drug: PLACEBO; Drug: SUNPG1623 III; Drug: SUNPG1623 IV

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • SPARC Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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: PLACEBO; injection; Drug: SUNPG1623 III; injection
Experimental: SUNPG1623 dose IV; mid range dose to high dose	Drug: PLACEBO; injection; Drug: SUNPG1623 IV; injection
Placebo Comparator: Placebo; mid range dose to high dose	Drug: PLACEBO; injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Physician Global Assessment of Disease Activity Visual Analog Scale	100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)	week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Patient's Global Assessment of Disease Activity	100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)	week 1, week 4, week 8, week 12, week 16, week 20 and week 24
Patient's Pain Assessment	100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).	week 1, week 4, week 8, week 12, week 16, week 20, and week 24
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	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	week 1, week 4, week 8, week 12, week 16, week 20, and week 24
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.	week 1, week 4, week 8, week 12, week 16, week 20, and week 24
The Proportion of Subjects Who Require Adjustment of Background Therapy		Week 16
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.	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	week 4, week 12 and 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.	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.	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	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.	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.	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.	Week 52
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)	Week 52
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)	Week 52
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).	Week 52
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	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. Change from Baseline in C-Reactive Protein.	Week 52
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.	Week 52
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	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: tender joint count ≤1;; swollen joint count ≤1;; PASI score ≤1 or BSA ≤3%;; patient Arthritis Pain (VAS)≤15 mm;; patient's global arthritis assessment (VAS) ≤20 mm;; HAQ-DI score ≤0.5;; tender entheseal points (using LEI) ≤1.	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.	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	Week 52

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CLR_16_23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No