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

- 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:
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.

- 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 with use of
Nonsteroidal Anti-Inflammatory Drug (NSAID)
- Requirement for anti-platelet or anticoagulant medication (for example,
warfarin, or clopidogrel or Novel Oral Anti-Coagulant - NOAC) other than
acetylsalicylic acid (up to 100 mg/d)
- History or presence of thrombotic or thromboembolic event, or increased risk
for thrombotic or thromboembolic event
- History or current treatment for hepatic disease including but not limited to
acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate
Aminotransferase (AST)/Alanine Aminotransferase (ALT) levels of more than 1.5 x
upper limit of normal (ULN) at last visit before Day 1 of the Treatment period
(either last available value from CLOU064A2201 or most recent value taken
during observational period)
- History of renal disease or creatinine level above 1.5x ULN at last visit
before Day 1 of the Treatment period (either last available value from
CLOU064A2201 or most recent value taken during observational period)
- 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