Efficacy and Safety Study of SUNPG1622

October 29, 2021 updated by: Sun Pharmaceutical Industries Limited

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • SPARC Site 3
  • Poland
      • Elbląg, Poland
        • SPARC Site 3
  • Spain
      • A Coruña, Spain
        • SPARC Site 2
  • United States
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • SPARC Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUNPG1622 I
SUNPG1622 I dose
Drug: SUNPG1622 I dose
Injection
Placebo Comparator: Placebo
Placebo dose
Drug: Placebo dose
Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of SpondyloArthritis International Society 20 Response Rates
Time Frame: Week 24
Percentage 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]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of SpondyloArthritis International Society 20 Response Rates
Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Percentage 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]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

September 3, 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)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_16_22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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