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A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma

NCT02794519 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-31

No results posted yet for this study

Summary

Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The continuing unmet need in subjects with asthma refractory to corticosteroid therapy and increased understanding of asthma pathogenesis have stimulated the development of targeted biologics based on predictive biomarkers. The majority of approaches to date have targeted T Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma represents an unprecedented approach that has potential to address non-Th2 drivers of severe asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled, parallel group study will investigate the efficacy of sirukumab compared to placebo in subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable treatment period for individual subjects. Dosing will continue every 4 weeks until week 44 (inclusive), or until 24 weeks after the final subject has been randomized, whichever the sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16 week Follow Up period. Overall, the duration of participation for subjects who complete the full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175 subjects will be randomized such that 140 evaluable subjects complete the study.

Conditions

Interventions

DRUG

Sirukumab

This intervention will be provided in a 1.0 mL pre-filled syringe (PFS) fitted with spring-powered, disposable autoinjector device for single SC use that is permanently assembled on the syringe. The sirukumab PFS is aseptically filled to deliver a dose of 50 mg/1.0 mL of sirukumab.

DRUG

Placebo

This intervention will be provided in a 1.0 mL pre-filled syringe (PFS) fitted with spring-powered, disposable autoinjector device for single SC use that is permanently assembled on the syringe. The sirukumab PFS is aseptically filled to deliver a dose of 50 mg/1.0 mL of sirukumab.

DRUG

Rescue medication

Rescue medication (salbutamol/albuterol) shall be supplied to subjects at Screening for use when needed during the study.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-23
Primary Completion
2016-10-04
Completion
2016-10-04

Countries

  • United States
  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794519 on ClinicalTrials.gov