MedTrace Logo

Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma

NCT04946318 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-10-10

No results posted yet for this study

Summary

The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).

Conditions

Interventions

DRUG

CSJ117

CSJ117 (0.5 mg, 1mg, 2mg, 4 mg and 8 mg) capsules for inhalation once daily delivered via Concept1 inhalation device for 12 or 24 weeks.

DRUG

Placebo

Placebo inhaled once daily for 12 or 24 weeks. Delivered via Concept1 device.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2022-09-08
Completion
2022-09-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • 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 NCT04946318 on ClinicalTrials.gov