NCT01723072

Brief Summary

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2014

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

November 5, 2012

Results QC Date

May 7, 2015

Last Update Submit

August 21, 2020

Conditions

Chronic Spontaneous UrticariaAngioedema

Keywords

Chronic spontanous urticaria, refractory CSU, Angioedema

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)

    The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.

    Baseline, 4, 12, 20, 28 and 36 weeks

Secondary Outcomes (15)

  • Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)

    Baseline, week 28; and the follow-up period (weeks 29-36)

  • Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes

    Baseline to week 28

  • Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)

    Baseline to week 28; and follow-up period (to week 36)

  • Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)

    week -2 to -1

  • Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)

    weeks 25 to 28

  • +10 more secondary outcomes

Study Arms (2)

1 Omalizumab

EXPERIMENTAL

omalizumab once a month via subcutaneous injection.

Biological: Omalizumab

2 Placebo

PLACEBO COMPARATOR

placebo of omalizumab once a month via subcutaneous injection

Drug: Placebo

Interventions

OmalizumabBIOLOGICAL

Humanized monoclonal antibody against human IgE

Also known as: IGE025
1 Omalizumab
PlaceboDRUG

Placebo to omalizumab

Also known as: Placebo for Omalizumab
2 Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
  • Presence of itch an hives for more than 6 weeks
  • UAS7 score of more than 14 (range 0-42)
  • Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
  • CSU diagnosis for more than 6 months
  • Angioedema at least 4x in the last 6 months

You may not qualify if:

  • Patients with non urticaria associated angioedema
  • History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
  • Evidence of parasitic infection
  • Previous treatment with omalizumab within the last 6 months prior to screening
  • History of anaphylactic shock
  • Woman who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Aachen, 52074, Germany

Location

Novartis Investigative Site

Augsburg, 86179, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Darmstadt, 64283, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Halle, 06120, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Homburg, 66421, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Oldenburg, 26133, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

Novartis Investigative Site

Wiesbaden, 65199, Germany

Location

Related Publications (1)

  • Staubach P, Metz M, Chapman-Rothe N, Sieder C, Brautigam M, Canvin J, Maurer M. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016 Aug;71(8):1135-44. doi: 10.1111/all.12870. Epub 2016 Mar 31.

    PMID: 27010957DERIVED

MeSH Terms

Conditions

Chronic UrticariaAngioedema

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
1-888-669-6682

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

January 23, 2013

Primary Completion

May 9, 2014

Study Completion

May 9, 2014

Last Updated

September 9, 2020

Results First Posted

September 9, 2020

Record last verified: 2020-08

Locations

DE(25)