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Efficacy and Safety Study of SUNPG1623

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980692
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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

Condition or disease Intervention/treatment Phase
Active Psoriatic Arthritis Drug: SUNPG1623 I Drug: SUNPG1623 II Drug: SUNPG1623 III Drug: SUNPG1623 IV Drug: PLACEBO Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : November 6, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SUNPG1623 I
Short-term dose
 Drug: SUNPG1623 I
injection
Experimental: SUNPG1623 II
Mid-term dose
 Drug: SUNPG1623 II
injection

Drug: PLACEBO
injection
Experimental: SUNPG1623 dose III
Mid-term dose
 Drug: SUNPG1623 III
injection

Drug: PLACEBO
injection
Experimental: SUNPG1623 dose IV
Mid to long-term dose
 Drug: SUNPG1623 IV
injection

Drug: PLACEBO
injection
Placebo Comparator: Placebo
Mid to long-term dose
 Drug: PLACEBO
injection


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who achieve response [ Time Frame: Week 24 ]
  2. Adverse events [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve response [ Time Frame: Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980692


Locations
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United States, Ohio
SPARC Site 1
Middleburg Heights, Ohio, United States, 44130
Sponsors and Collaborators
Sun Pharma Global FZE
More Information
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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02980692    
Other Study ID Numbers: CLR_16_23
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases