MedTrace Logo

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

NCT03926611 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2022-04-29

Study results available
· View outcomes & findings →

Summary

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Conditions

Interventions

DRUG

LOU064 Arm 1

10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

DRUG

LOU064 Arm 2

35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

DRUG

LOU064 Arm 3

100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85

DRUG

LOU064 Arm 4

10mg bid of LOU064 orally, twice daily from Day 1 to 85

DRUG

LOU064 Arm 5

25 mg bid of LOU064 orally, twice daily from Day 1 to 85

DRUG

LOU064 Arm 6

100 mg bid of LOU064 orally, twice daily from Day 1 to 85

DRUG

Placebo arm

Matching placebo, orally, twice daily from Day 1 to 85

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
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2021-01-14
Completion
2021-04-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03926611 on ClinicalTrials.gov