Open-label, Multicenter, Extension Study to Evaluate Long-term Safety and Tolerability of LOU064 in Subjects With CSU
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|ClinicalTrials.gov Identifier: NCT04109313|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2019
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Drug: LOU064||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This study consists of 3 periods:
Observational Period: for upto 12 weeks Treatment Period: for 52 weeks Treatment free follow up period: for a minimum of 4 weeks to a maximum of 16 weeks
Subjects rolling over from CLOU064A2201 will be assigned to one of the periods as follows:
After relapse (UAS7≥16 at least once), the observational period can be terminated immediately and subjects may enter the treatment period. Subjects who have never relapsed within 12 weeks will discontinue the study after the observational period.
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in Preceding Studies With LOU064|
|Actual Study Start Date :||October 24, 2019|
|Estimated Primary Completion Date :||November 4, 2022|
|Estimated Study Completion Date :||November 4, 2022|
Participants will be asked to take selected dose of LOU064 twice daily for 52 weeks
selected dose of LOU064 taken orally twice a day (morning and evening) from day 1 to week 52 of the Treatment period.
- long-term safety and tolerability of LOU064 [ Time Frame: overtime from week 1 to week 68 ]
To assess the long-term safety and tolerability of LOU064 in patients with CSU who have participated in preceding studies with LOU064.
Safety endpoints will include but not be limited to: occurrence of treatment emergent (serious and non-serious) adverse events during the extension study
- Change from baseline in Utricaria Activity Score (UAS 7); UAS7≤6; UAS7=0 [ Time Frame: Week 4 ]To evaluate the efficacy of LOU064 when given without H1-antihistamines in patients with CSU with respect to change from baseline in UAS7, achieving controlled disease (defined by a UAS7≤6), and achieving complete response (defined by a UAS7=0) at Week 4 of treatment
- UAS7≤ 6 [ Time Frame: over time from week 1 to week 68 ]To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in previous studies with LOU064 with respect to maintaining or achieving controlled disease (defined by a UAS7≤6) over time
- Change from baseline in UAS7 [ Time Frame: over time from week 1 to week 68 ]To evaluate the long-term efficacy of LOU064 in patients with CSU who have participated in preceding studies with LOU064 with respect to change from baseline in UAS7 over time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109313
|Study Director:||Novartis Pharmaceutical||Novartis Pharmaceutical|