NCT02980692

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

January 27, 2023

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

November 30, 2016

Results QC Date

October 3, 2020

Last Update Submit

January 3, 2023

Conditions

Active Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

  • Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate

    week 52

  • 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

  • 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

  • Change From Baseline in Tender Joint Counts

    week 1, week 4, week 8, week 12, week 16, week 20, and week 24

  • Change From Baseline in Tender Joint Counts

    Week 52

  • +21 more secondary outcomes

Study Arms (5)

SUNPG1623 dose I

EXPERIMENTAL

low range dose

Drug: SUNPG1623 I

SUNPG1623 dose II

EXPERIMENTAL

mid range dose

Drug: SUNPG1623 IIDrug: PLACEBO

SUNPG1623 dose III

EXPERIMENTAL

mid range dose

Drug: SUNPG1623 IIIDrug: PLACEBO

SUNPG1623 dose IV

EXPERIMENTAL

mid range dose to high dose

Drug: SUNPG1623 IVDrug: PLACEBO

Placebo

PLACEBO COMPARATOR

mid range dose to high dose

Drug: PLACEBO

Interventions

SUNPG1623 IDRUG

injection

SUNPG1623 dose I
SUNPG1623 IIDRUG

injection

SUNPG1623 dose II
SUNPG1623 IIIDRUG

injection

SUNPG1623 dose III
SUNPG1623 IVDRUG

injection

SUNPG1623 dose IV
PLACEBODRUG

injection

PlaceboSUNPG1623 dose IISUNPG1623 dose IIISUNPG1623 dose IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC Site 1

Middleburg Heights, Ohio, 44130, United States

Location

Related Publications (1)

  • 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.

    PMID: 33985942DERIVED

Results Point of Contact

Title
Head-Clinical Development
Organization
Sun Pharma Advanced Research Company Limited
clinical.trials@sparcmail.com
912266455645

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

April 19, 2017

Primary Completion

March 1, 2019

Study Completion

September 24, 2019

Last Updated

January 27, 2023

Results First Posted

May 19, 2021

Record last verified: 2022-08

Locations

US(1)