Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02550106
Other study ID # CIGE025EFR02
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 22, 2015
Est. completion date January 11, 2016

Study information

Verified date February 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date January 11, 2016
Est. primary completion date January 11, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Male or female patients aged between 18 and 75 years.

- Diagnosis of CSU for = 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:

- The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.

- Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1)

- Current use of an H1 antihistamine for CSU on the day of the initial visit and Day

- Informed consent

Exclusion Criteria:

- Treatment with an investigational agent within 30 days before enrollment.

- Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.

- Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7

- Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.

- Any H2 antihistamine use within 7 days prior to Day -7.

- Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.

- Concomitant use of cyclosporine or any other immunosuppressive agent.

- Hypersensitivity to omalizumab or any component of the formulation.

- History of anaphylactic shock.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OMALIZUMAB
sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Locations

Country Name City State
France Novartis Investigative Site Angers cedex 09
France Novartis Investigative Site Argenteuil
France Novartis Investigative Site Besancon Cedex
France Novartis Investigative Site Bobigny Cedex
France Novartis Investigative Site Bordeaux Cedex
France Novartis Investigative Site Chalons-en-Champagne
France Novartis Investigative Site Clermont Ferrand cedex 1
France Novartis Investigative Site Dijon
France Novartis Investigative Site Grenoble
France Novartis Investigative Site Lille
France Novartis Investigative Site Lille Cedex
France Novartis Investigative Site Limoges cedex Haute Vienne
France Novartis Investigative Site Lyon cedex 04
France Novartis Investigative Site Marseille Cedex 05
France Novartis Investigative Site Montpellier cedex 5
France Novartis Investigative Site Nantes
France Novartis Investigative Site Nice
France Novartis Investigative Site Nimes Cedex
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris Cedex 10 Cedex 10
France Novartis Investigative Site Quimper
France Novartis Investigative Site Reims
France Novartis Investigative Site Rennes Cedex 9
France Novartis Investigative Site Rouen
France Novartis Investigative Site Saint-Etienne
France Novartis Investigative Site Toulon Cedex 9 Val De Marne
France Novartis Investigative Site Toulouse Cedex
France Novartis Investigative Site Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
WEEK 12
Secondary Percent of Participants With UAS7=6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema 2 patients with angioedema status were missing at baseline and not included WEEK 12
Secondary CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease.
Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42).
baseline and week 12
Secondary Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12.
The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease.
A score of =12 indicates well-controlled urticaria.
baseline and week 12
Secondary Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. week 16
Secondary Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. week 20
Secondary Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control week 24
Secondary Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. week 28
Secondary The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12.
The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life.
baseline and week 12
Secondary The Angioedema Quality of Life (AE-QoL) The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients.
The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment
baseline and week 12
Secondary The Dermatology Life Quality Index (DLQI) The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). baseline and week 12
Secondary Angioedema Activity Using the Angioedema Activity Score (AAS) The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity. baseline and week 12
See also
  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