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Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

NCT04410523 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2024-06-20

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Conditions

Interventions

DRUG

CSJ117

CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device. CSJ117 = inhaled monoclonal antibody fragment

DRUG

Placebo

Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period. Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2022-07-12
Completion
2022-09-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Guatemala
  • Hungary
  • Japan
  • Latvia
  • Philippines
  • Poland
  • Russia
  • Slovakia

Study Locations

More Related Trials

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 NCT04410523 on ClinicalTrials.gov