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Efficacy and Safety Study of SUNPG1622

This study is not yet open for participant recruitment.
Verified May 2017 by Sun Pharma Global FZE
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980705
First Posted: December 2, 2016
Last Update Posted: May 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Pharma Global FZE
  Purpose
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sun Pharma Global FZE:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 180
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUNPG1622 I
SUNPG1622 I dose
Drug: SUNPG1622 I dose
Injection
Placebo Comparator: Placebo
Placebo dose
Drug: Placebo dose
Injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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

Sponsors and Collaborators
Sun Pharma Global FZE
  More Information

Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02980705     History of Changes
Other Study ID Numbers: CLR_16_22
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: May 15, 2017
Last Verified: May 2017

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