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LOU064 for Chronic Urticaria

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of treatment up to 28 days after last dose, assessed up to 56 weeks
Awards & highlights

Study Summary

This trial is for people who completed other studies testing the safety and tolerability of the drug LOU064. It will help researchers understand the long-term effects of the drug.

Eligible Conditions
  • Chronic Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of treatment up to 28 days after last dose, assessed up to 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of treatment up to 28 days after last dose, assessed up to 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events (AEs)
Secondary outcome measures
Change From Baseline in UAS7 Overtime
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 of the Treatment Period
Percentage of Participants With Complete Response (UAS7=0) at Week 4 of the Treatment Period
+2 more

Side effects data

From 2022 Phase 2 trial • 229 Patients • NCT04109313
11%
Chronic spontaneous urticaria
8%
COVID-19
7%
Headache
5%
Eczema
1%
COVID-19 pneumonia
1%
Chest pain
1%
Ovarian cyst
1%
Tibia fracture
1%
Melaena
1%
Appendicitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treated Cohort (Treatment+Follow-up Period)
Treatment-free Cohort (Observational Period)

Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
Participants with UAS7<16 at Week 16 of CLOU064A2201 were followed up to 12 weeks without receiving treatment (observational period). If participants relapsed (UAS7≥16 at least once), they were transitioned to the treatment period. Otherwise, they were discontinued from the study. Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered 100 mg of LOU064 b.i.d. open-label for up to 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOU064
2022
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,121 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,895 Patients Enrolled for Chronic Urticaria
Novartis PharmaceuticalStudy DirectorNovartis Pharmaceutical
8 Previous Clinical Trials
7,077 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
2019. "An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109313.
~42 spots leftby Apr 2025
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