Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines
Verified date | April 2022 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was 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
Status | Completed |
Enrollment | 311 |
Est. completion date | April 15, 2021 |
Est. primary completion date | January 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Male and female subjects aged =18 years of age - CSU diagnosis for = 6 months prior to screening - Presence of itch and hives for =6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period - UAS7 score (range 0-42) =16 and HSS7 score (range 0-21) = 8 during 7 days prior to randomization (Day 1) - Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study Exclusion Criteria: - Hypersensitivity to any of the study treatments - Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) - Other diseases with symptoms of urticaria or angioedema - Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, - 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. - Pregnant or nursing (lactating) women - Women of child-bearing potential not using highly effective methods of contraception |
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Caba | |
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Argentina | Novartis Investigative Site | Ciudad de Mendoza | Mendoza |
Argentina | Novartis Investigative Site | La Plata | Buenos Aires |
Belgium | Novartis Investigative Site | Edegem | Antwerpen |
Belgium | Novartis Investigative Site | Liege | |
Canada | Novartis Investigative Site | Edmonton | Alberta |
Canada | Novartis Investigative Site | London | Ontario |
Canada | Novartis Investigative Site | Niagara Falls | Ontario |
Canada | Novartis Investigative Site | Ottawa | Ontario |
Canada | Novartis Investigative Site | Quebec | |
Canada | Novartis Investigative Site | Verdun | Quebec |
Czechia | Novartis Investigative Site | Prague | Prague 1 |
Czechia | Novartis Investigative Site | Prague 8 | Czech Republic |
Czechia | Novartis Investigative Site | Tabor | |
Denmark | Novartis Investigative Site | Arhus C | |
Denmark | Novartis Investigative Site | Copenhagen NV | |
France | Novartis Investigative Site | Lille Cedex | |
France | Novartis Investigative Site | Nantes Cedex 1 | |
France | Novartis Investigative Site | Nice Cedex | |
France | Novartis Investigative Site | Pierre Benite Cedex | |
France | Novartis Investigative Site | Rouen | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Dresden | |
Germany | Novartis Investigative Site | Gera | |
Germany | Novartis Investigative Site | Hannover | |
Germany | Novartis Investigative Site | Muenchen | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Debrecen | |
Hungary | Novartis Investigative Site | Debrecen | Hajdu Bihar |
Hungary | Novartis Investigative Site | Oroshaza | |
Hungary | Novartis Investigative Site | Pecs | |
Hungary | Novartis Investigative Site | Szolnok | |
Japan | Novartis Investigative Site | Funabashi | Chiba |
Japan | Novartis Investigative Site | Hiroshima City | Hiroshima |
Japan | Novartis Investigative Site | Ichinomiya | Aichi |
Japan | Novartis Investigative Site | Itabashi-ku | Tokyo |
Japan | Novartis Investigative Site | Koto | Tokyo |
Japan | Novartis Investigative Site | Obihiro | Hokkaido |
Japan | Novartis Investigative Site | Takaoka | Toyama |
Japan | Novartis Investigative Site | Yokohama | Kanagawa |
Japan | Novartis Investigative Site | Yokohama | Kanagawa |
Japan | Novartis Investigative Site | Yokohama | Kanagawa |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Utrecht | |
Poland | Novartis Investigative Site | Gdansk | |
Poland | Novartis Investigative Site | Lodz | |
Poland | Novartis Investigative Site | Lodz | |
Poland | Novartis Investigative Site | Rzeszow | |
Poland | Novartis Investigative Site | Warszawa | |
Poland | Novartis Investigative Site | Wroclaw | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | St Petersburg | |
Russian Federation | Novartis Investigative Site | St.-Petersburg | |
Russian Federation | Novartis Investigative Site | Stavropol | |
Slovakia | Novartis Investigative Site | Kosice | Slovak Republic |
Slovakia | Novartis Investigative Site | Nove Zamky | |
Slovakia | Novartis Investigative Site | Svidnik | |
Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Turkey | Novartis Investigative Site | Denizli | |
Turkey | Novartis Investigative Site | Istanbul | TUR |
Turkey | Novartis Investigative Site | Talas / Kayseri | |
United Kingdom | Novartis Investigative Site | Leeds | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Oxford | |
United Kingdom | Novartis Investigative Site | Plymouth | |
United States | Novartis Investigative Site | Grove City | Ohio |
United States | Novartis Investigative Site | Litchfield Park | Arizona |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Mission Viejo | California |
United States | Novartis Investigative Site | Owensboro | Kentucky |
United States | Novartis Investigative Site | Pembroke Pines | Florida |
United States | Novartis Investigative Site | Saint Louis | Missouri |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | Walnut Creek | California |
United States | Novartis Investigative Site | Westminster | California |
United States | Novartis Investigative Site | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Netherlands, Poland, Russian Federation, Slovakia, Spain, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 | UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement. |
Baseline, Week 4 | |
Secondary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 | UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) | Week 12 | |
Secondary | Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6) | UAS7=0 and UAS7<=6 response rate over time by treatment group (non-responder imputation) The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates more severe disease. A negative change score (week 4 score minus Baseline score) indicates improvement. | Week 12 | |
Secondary | Cumulative Number of Weeks With an AAS7=0 Response | The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reports the occurrence of angioedema ("opening question") with "no", AAS score for this day is 0. If "yes" is the answer to the opening question, the subject will continue to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105. Higher score means more severe disease. | Baseline to Week 12 | |
Secondary | Percentage of Participants With DLQI Score of 0 or 1 | Percentage of subjects with DLQI 0/1 response by treatment group and visit (non-responder imputation)
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life. |
Week 4 and Week 12 | |
Secondary | Mean Change From Baseline in DLQI Score | Summary of DLQI score and change from baseline
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). |
Baseline, Week 4 and Week 12 | |
Secondary | Area Under the Blood Concentration-time Curve (AUC) of LOU064 | Assessment of the area under the blood concentration-time curve (AUC) up to four hours following oral administration at Week 4 and Week 12 . | Week 4 and Week 12 | |
Secondary | Observed Maximum Blood Concentration (Cmax) of LOU064 | Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 . | Week 4 and Week 12 | |
Secondary | Time to Reach the Maximum Concentration (Tmax) of LOU064 | Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Weeks 4 and 12 | Week 4 and Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06077773 -
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
|
Phase 2 | |
Completed |
NCT04538794 -
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
|
Phase 1 | |
Completed |
NCT01803763 -
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
|
Phase 2/Phase 3 | |
Recruiting |
NCT05298215 -
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria
|
Phase 2 | |
Terminated |
NCT04612725 -
A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
|
Phase 2 | |
Terminated |
NCT05528861 -
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
|
Phase 2 | |
Completed |
NCT04109313 -
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU
|
Phase 2 | |
Completed |
NCT03580356 -
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
|
Phase 3 | |
Completed |
NCT03580369 -
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
|
Phase 3 | |
Completed |
NCT05030311 -
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
|
Phase 3 | |
Recruiting |
NCT06162728 -
Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
|
Phase 1/Phase 2 | |
Completed |
NCT05107115 -
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
|
Phase 2 | |
Recruiting |
NCT06042478 -
A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.
|
Phase 3 | |
Terminated |
NCT04159701 -
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
|
Phase 2 | |
Completed |
NCT03749135 -
Dupilumab in Chronic Spontaneous Urticaria
|
Phase 2 | |
Not yet recruiting |
NCT06396026 -
A Study of Efficacy and Safety of TLL-018 in CSU Participants
|
Phase 3 | |
Completed |
NCT02649218 -
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
|
Phase 2 | |
Active, not recruiting |
NCT05368285 -
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
|
Phase 2 | |
Completed |
NCT05373355 -
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
|
Phase 1 | |
Not yet recruiting |
NCT06365879 -
To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
|
Phase 3 |