Study ID: SD-809-C-20

Study Title

Reducing Involuntary Movements in Participants With Tardive Dyskinesia (RIM-TD)

Teva Identifier

SD-809-C-20

ClinicalTrials.gov Identifier

NCT02198794

Study Status

Completed

Trial Condition(s)

Tardive Dyskinesia

Interventions

Drug: SD-809 | Drug: Placebo

EudractCT Number

2014-001891-73

Study Description

The primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype. The planned study duration is approximately 16 months. The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.


Key Participation Requirements

Gender

Female, Male

Age Range

18 Years to 50 Years

Trial Duration

October 20, 2014 - December 14, 2020

Phase

Phase 3

Study Type

Interventional