CLINICAL TRIALS PROFILE FOR LOU064

Clinical Trials for LOU064

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03918980 ↗	Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064	Completed	Novartis Pharmaceuticals	Phase 1	This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5 is in health volunteers and part 6 is in subjects with atopic dermatitis. The purpose of this first-in-human study is to assess the safety and tolerability and pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily oral administration in healthy volunteers and those with atopic diathesis or atopic dermatitis. This study will also explore the effect of food intake and different drug substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide dosing and formulation development for future clinical trials. The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April 2019).
NCT03926611 ↗	Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines	Completed	Novartis Pharmaceuticals	Phase 2	This is a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines
NCT03944707 ↗	Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients	Terminated	Novartis Pharmaceuticals	Phase 2	This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).
NCT04035668 ↗	A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome	Recruiting	Novartis Pharmaceuticals	Phase 2	LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor. This study is an adaptive phase 2 study designed to establish safety and efficacy and characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome.

Clinical Trial Conditions for LOU064

Condition Name

Condition Name
Intervention	Trials
Chronic Spontaneous Urticaria	8
Relapsing Multiple Sclerosis	2
Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis	1
Hepatic Impairment	1

Condition MeSH

Condition MeSH
Intervention	Trials
Urticaria	10
Chronic Urticaria	9
Sclerosis	2
Multiple Sclerosis	2

Clinical Trial Locations for LOU064

Trials by Country

Trials by Country
Location	Trials
United States	39
Japan	18
Spain	17
Canada	15
China	14

Trials by US State

Trials by US State
Location	Trials
Missouri	3
Kentucky	3
Florida	3
California	3
Arkansas	3

Clinical Trial Progress for LOU064

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	10
Phase 2	5
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Not yet recruiting	9
Recruiting	4
Completed	2

Clinical Trial Sponsors for LOU064

Sponsor Name

Sponsor Name
Sponsor	Trials
Novartis Pharmaceuticals	17

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	17