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 CLOU064A2201

JRCT ID: jRCT2031210538

Registered date:05/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic spontaneous urticaria
• Date of first enrollment: 26/10/2019
• Target sample size: 45
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Canada,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Hungary,Japan,Poland,Japan,Russia,Japan,Slovakia,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan,Turkey,Japan
• Study type: Interventional
• Intervention(s): LOU064 taken orally twice a day

Outcome(s)

Primary Outcome

long-term safety and tolerability of LOU064
[ Time Frame: overtime from week 1 to week 68 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Takamitsu Hirano
• Secondary ID(s): NCT04109313