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Efficacy and Safety Study of SUNPG1622

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ClinicalTrials.gov Identifier: NCT02980705
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Brief Summary:
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

Condition or disease Intervention/treatment Phase
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Drug: SUNPG1622 I dose Drug: Placebo dose Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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 Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SUNPG1622 I
SUNPG1622 I dose
Drug: SUNPG1622 I dose
Injection
Placebo Comparator: Placebo
Placebo dose
Drug: Placebo dose
Injection



Primary Outcome Measures :
  1. Proportion of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]) [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]) [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subject has provided informed written consent
  • Subject is ≥ 18 years of age at time of Screening
  • Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
  • Subject has a negative test for TB within 4 weeks before initiating IMP

Exclusion Criteria:

  • Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
  • Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
  • Radiographic evidence of total ankylosis of the spine
  • Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition

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): NCT02980705


Contacts
Contact: Shravanti Bhowmik, MD 912266455645 shravanti.bhowmik@sparcmail.com

Locations
United States, Ohio
SPARC Site 1 Recruiting
Middleburg Heights, Ohio, United States, 44130
Sponsors and Collaborators
Sun Pharma Global FZE

Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02980705     History of Changes
Other Study ID Numbers: CLR_16_22
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis