An open-label extension study to evaluate the long-term safety and tolerability of LOU064 in subjects with CS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

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 must have completed the Week 12 visit (end of treatment period) or the Week 16 visit (end of the follow-up period) of CLOU064A2201 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:
a) 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 rollover into CLOU064A2201E1 but need to enter the follow-up period of CLOU064A2201).
b) Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7=16 will be allocated to the Treatment period.
c) Subjects rolling over at Week 16 of CLOU064A2201 with a UAS7<16 will be allocated to the Observational period.
- Rollover criteria for subjects with CSU from other, not-yet specified studies with LOU064 will be detailed in the protocols of these studies.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) prior to enrollment or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- 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 urticaria
- Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria
- 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
- Patients/subjects taking medications prohibited by the protocol
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study medication.
- Sexually active males must use a condom during intercourse while taking drug and for 7 days after stopping study medication and should not father a child in this period. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
- Major surgery within 8 weeks prior to enrollment or surgery planned prior to end of the treatment period.
- History of live attenuated vaccine within 6 weeks prior to enrollment or requirement to receive these vaccinations at any time during study drug treatment
- Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participant participation.
- Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
- Hematology parameters at last visit before Day 1 of the Treatment period (either last available value from CLOU064A2201 or most recent value taken during observational period): Hemoglobin: < 10 g/dl; Platelets: < 100 000/mm3; White blood cells: < 3 000/mm3; Neutrophils: < 1 500/mm3;
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding, eg in association wi

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 12/16/2019

An open-label extension study to evaluate the long-term safety and tolerability of LOU064 in subjects with CS

Recruitment & Eligibility

Study & Design

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