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Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment (SUNRISE)

Primary Purpose

CHRONIC SPONTANEOUS URTICARIA

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

OMALIZUMAB

About this trial

This is an interventional treatment trial for CHRONIC SPONTANEOUS URTICARIA focused on measuring CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST, IGE025

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMALIZUMAB

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

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.

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.

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

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

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 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.

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

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).

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.

Full Information

NCT ID

NCT02550106

First Posted

March 9, 2015

Last Updated

February 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02550106

Brief Title

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Acronym

SUNRISE

Official Title

A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

April 22, 2015 (Actual)

Primary Completion Date

January 11, 2016 (Actual)

Study Completion Date

January 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CHRONIC SPONTANEOUS URTICARIA

Keywords

CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST, IGE025

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMALIZUMAB

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

OMALIZUMAB

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12

Description

Time Frame

WEEK 12

Secondary Outcome Measure Information:

Title

Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema

Description

2 patients with angioedema status were missing at baseline and not included

Time Frame

WEEK 12

Title

CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema

Description

Time Frame

baseline and week 12

Title

Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12

Description

Time Frame

baseline and week 12

Title

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

Description

Time Frame

week 16

Title

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

Description

Time Frame

week 20

Title

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

Description

Time Frame

week 24

Title

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

Description

Time Frame

week 28

Title

The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire

Description

Time Frame

baseline and week 12

Title

The Angioedema Quality of Life (AE-QoL)

Description

Time Frame

baseline and week 12

Title

The Dermatology Life Quality Index (DLQI)

Description

Time Frame

baseline and week 12

Title

Angioedema Activity Using the Angioedema Activity Score (AAS)

Description

Time Frame

baseline and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: