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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is an open-label, single arm, multicenter, long-term safety and tolerability extension study for CSU patients who completed CLOU064A2201 or other preceding studies with LOU064

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: LOU064 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: N/A
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:

  • Subjects with a UAS7≥16 at Week 12 or Week 16 will directly enter the treatment period. (Subjects with a UAS7<16 at Week 12 of CLOU064A2201 enter the follow-up period of CLOU064A2201)
  • Subjects with a UAS7<16 at Week 16 (i.e., who have not relapsed during the follow-up period of CLOU064A2201) will be assigned to the observational period.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: LOU064
Participants will be asked to take selected dose of LOU064 twice daily for 52 weeks
Drug: LOU064
selected dose of LOU064 taken orally twice a day (morning and evening) from day 1 to week 52 of the Treatment period.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
  • Subjects rolling over from CLOU064A2201 must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) and will be allocated to the treatment period or the observational period of CLOU064A2201E1 based on the UAS7 score (of the 7 days prior to the respective visit) as follows:

    • Subjects rolling over at Week 12 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period (note: subjects with UAS7<16 at Week 12 are not eligible to roll-over into CLOU064A2201E1 but need to enter the follow-up period of CLOU064A2201).
    • Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7≥16 will be allocated to the Treatment period.
    • Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7<16 will be allocated to the Observational period.

Exclusion Criteria:

  • Subjects having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticarial
  • Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticarial pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticarial
  • Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects participating in the study such as:

    • Concomitant clinically significant cardiac arrhythmias, eg sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
    • History of familial long QT syndrome or known family history of Torsades de Pointes
    • Resting heart rate (physical exam or 12 lead ECG) < 60 bpm
    • Resting QTcF ≥450 msec (male) or ≥460 msec (female) at day 1 of the treatment period or inability to determine the QTcF interval
    • Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
  • Significant bleeding risk or coagulation disorders
  • Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C

Other protocol defined inclusion exclusion criteria may apply


Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceutical Novartis Pharmaceutical
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04109313    
Other Study ID Numbers: CLOU064A2201E1
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic spontaneous urticaria
BTK Inhibitor
Long term safety
Urticaria activity score
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases