NCT02980705TerminatedPhase 2
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
Sun Pharmaceutical Industries Limited3 sites in 3 countries180 target enrollmentStarted: November 6, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 180
- Locations
- 3
- Primary Endpoint
- Assessment of SpondyloArthritis International Society 20 Response Rates
Study Overview
Brief Summary
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SUNPG1622 I
Experimental
SUNPG1622 I dose
Intervention: SUNPG1622 I dose (Drug)
Placebo
Placebo Comparator
Placebo dose
Intervention: Placebo dose (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Assessment of SpondyloArthritis International Society 20 Response Rates(Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Phase 1
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)Influenza InfectionNCT05818124Merck Sharp & Dohme LLC161
Completed
Phase 2
To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaParkinson's Disease DementiaNCT03413384BrainX Corporation100
Completed
Phase 2
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)Hypertension, PulmonaryNCT04945460Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA164
Completed
Phase 2
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic GastroparesisGastroparesisNCT04026997CinDome Pharma, Inc.73
Completed
Phase 2
A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate TherapyRheumatoid ArthritisNCT01242917Amgen159