24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Condition(s) studied
Investigational drug(s) / intervention(s)
LOU064 (blinded): LOU064 (blinded) active treatment
placebo: matching active drug
Study summary
The purpose of this trial is:
1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
3. to collect safety data in this population for up to three years after the last dose of study treatment
Eligibility
Primary outcome measure(s)
- Change from baseline in UAS7 — Baseline, week 12
The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Negative change from baseline indicates improvement. - Change fron baseline in ISS7 — Baseline, Week 12
Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement. - Change from baseline in HSS7 — Baseline, Week 12
Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\>12 hives/12 hours). Negative change from baseline indicates improvement.
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Kern Research | Bakersfield | California | |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | |
| Pediatric Dermatology of Miami at the Pediatric CoE | Miami | Florida | |
| Treasure Valley Medical Research | Boise | Idaho | |
| Endeavor Health | Glenview | Illinois | |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | |
| Toledo Institute of Clinical Research | Toledo | Ohio | |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | |
| RFSA Dermatology | San Antonio | Texas | |
| Allergy Associates of Utah | Sandy City | Utah | |
| Novartis Investigative Site | CABA | Buenos Aires | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | San Miguel de Tucumán | Argentina | |
| Novartis Investigative Site | Montreal | Quebec | |
| Novartis Investigative Site | Santiago | Santiago Metropolitan | |
| Novartis Investigative Site | Guangzhou | Guangdong | |
| Novartis Investigative Site | Chengdu | Sichuan | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Frankfurt am Main | Hesse | |
| Novartis Investigative Site | Berlin | Germany | |
| Novartis Investigative Site | Tübingen | Germany | |
| Novartis Investigative Site | Hong Kong | Hong Kong | |
| Novartis Investigative Site | Florence | FI | |
| Novartis Investigative Site | Pavia | PV | |
| Novartis Investigative Site | Siena | SI | |
| Novartis Investigative Site | Kitakyushu | Fukuoka | |
| Novartis Investigative Site | Kamimashi-gun | Kumamoto | |
| Novartis Investigative Site | Sakai | Osaka | |
| Novartis Investigative Site | Izumo | Shimane | |
| Novartis Investigative Site | Itabashi-ku | Tokyo | |
| Novartis Investigative Site | Kuching | Sarawak | |
| Novartis Investigative Site | Utrecht | Netherlands | |
| Novartis Investigative Site | Lodz | Poland | |
| Novartis Investigative Site | Pretoria | Gauteng | |
| Novartis Investigative Site | Cape Town | South Africa | |
| Novartis Investigative Site | Esplugues | Barcelona | |
| Novartis Investigative Site | Valencia | Spain |
+ 9 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05677451 on ClinicalTrials.gov ↗ ← All trials in Italy