CLINICAL TRIALS PROFILE FOR LOU064
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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. |
| NCT04109313 ↗ | Open-label, Multicenter, Extension Study to Evaluate Long-term Safety and Tolerability of LOU064 in Subjects With CSU | Active, not recruiting | Novartis Pharmaceuticals | Phase 2 | 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 |
| NCT05030311 ↗ | A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines | Not yet recruiting | Novartis Pharmaceuticals | Phase 3 | The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo. |
| NCT05032157 ↗ | A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines | Not yet recruiting | Novartis Pharmaceuticals | Phase 3 | The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for LOU064
Condition Name
| Condition Name for | |
| Intervention | Trials |
| Chronic Spontaneous Urticaria | 7 |
| Relapsing Multiple Sclerosis | 2 |
| Chronic Spontaneous Urticaria (CSU) | 1 |
| Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for LOU064
Trials by Country
Clinical Trial Progress for LOU064
Clinical Trial Phase
Clinical Trial Sponsors for LOU064
Sponsor Name
