Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)

NCT03111628 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB00105590R01AI116658
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU ( chronic idiopathic Urticaria) patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE bearing cell type associated with clinical symptom change.

Conditions

Urticaria Chronic

Outcome Measures

Primary Outcomes (1)

• Time to 50% Decline in Clinical Symptoms Measured by the Urticaria Activity Score Seven Day(UAS7)

  The time (in days) to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score (UAS) from baseline (Wk -7 to Day -1) to the date at which an Minimally Important Difference (5 point change in weekly UAS 7) or achievement of \> 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the baseline. The UAS is a validated measure of CIU disease activity calculated from the average of twice daily recorded itch (0 - 3; 0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch) and hives (0 - 3, 0= no hives, 1= 1-6 hives, 2= 7-12 hives, 3= \> 12 hives in the past 12 hours) scores with a daily maximum of 6. The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42 The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42.

  From first injection to time of meaningful change, up to 12 Weeks

Study Arms (1)

Omalizumab

OTHER

Omalizumab 300mg every month for 3 doses

Drug: Omalizumab

Interventions

Omalizumab DRUG

omalizumab 300 mg every 4 weeks by subcutaneous injection

Also known as: Xolair

Omalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age \>18 years old
• Females must be surgically sterile or postmenopausal or using a highly effective form of birth control throughout the duration of the study.
• Females must have a negative urine pregnancy test at screening and other visits specified in this protocol unless documented to have a hysterectomy or be postmenopausal.
• Clinical history of CIU at the time of screening, as defined by pruritus and hives for \> 3 days in a 7-day period for \> 6 consecutive weeks despite treatment with H1 antihistamine.
• CIU diagnosis \> 3 months (by history)
• No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria).
• Non-diary based UAS scores ≥ 2 at either the screening visit (Week -3), at the run-in visit (Week -2), or on Day 1.
• Compliance with study procedures during run-in period (e.g., completion of the study diary).

You may not qualify if:

• Pregnant females, Recent history of drug or alcohol abuse (within 3 years prior to screening visit).Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• Use of any investigational drugs within 30 days of screening.
• Active atopic dermatitis or other skin disease associated with pruritus during the time of the study, which require treatment with topical corticosteroids.
• Clinically relevant major systemic disease (making interpretation of the study results difficult) including a history of anaphylaxis.
• Inability to comply with study and follow-up procedures
• Patients may not use oral or systemic steroids during the study or within 4 weeks prior to enrollment.
• Patients may not take H2 antihistamines and leukotriene receptor antagonists within 7 days before screening, during the screening, run-in, or treatment phases. The exception will be if they are already on these medications for the treatment of Gastro-Esophageal Reflux Disease (GERD), asthma or allergic rhinitis.
• Any clinically relevant abnormal findings in clinical chemistry, hematology, urinalysis, physical examination, pulse, blood pressure at baseline, which, in the opinion of the investigator, could put the patient at risk because of his/her participation in the study.
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality of the data obtained from the study.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

• Kaplan AP, Gimenez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy. 2017 Apr;72(4):519-533. doi: 10.1111/all.13083. Epub 2017 Jan 4.

  PMID: 27861988 BACKGROUND

• Johal KJ, Chichester KL, Oliver ET, Devine KC, Bieneman AP, Schroeder JT, MacGlashan DW Jr, Saini SS. The efficacy of omalizumab treatment in chronic spontaneous urticaria is associated with basophil phenotypes. J Allergy Clin Immunol. 2021 Jun;147(6):2271-2280.e8. doi: 10.1016/j.jaci.2021.02.038. Epub 2021 Mar 10.

  PMID: 33713769 RESULT

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarbjit S. Saini
• Organization: JohnsHopkinsU

ssaini@jhmi.edu

410550-2129

Study Officials

• Sarbjit Saini, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active therapy

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: October 6, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 14, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)