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Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

NCT05104892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-03-07

No results posted yet for this study

Summary

This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol \[non-investigational medicinal product\], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below:

* Screening period (4 weeks)
* Randomized IMP treatment period (12 weeks ± 3 days)

* Background therapy stabilization phase (4 weeks)
* Background therapy withdrawal phase (4-5 weeks)
* No background therapy phase (3-4 weeks)
* Post IMP treatment safety follow-up period (4 weeks ± 3 days)

Conditions

Interventions

DRUG

Rilzabrutinib

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

placebo

Pharmaceutical form: Tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-12
Primary Completion
2024-02-06
Completion
2024-02-28

Countries

  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT05104892 on ClinicalTrials.gov