Biologics and Sublingual Immunotherapy

NCT06027073 | Not Yet Recruiting Phase 4

• 1 other identifier: CM-01966
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.

Conditions

Asthma, Allergic

Keywords

IgE; asthma; omalizumab; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Assess the effectiveness of combined therapy : omalizumab+ immunotherapy

  Daily dose of inhaled steroids (changes)

  3 years

Study Arms (4)

omalizumab

ACTIVE COMPARATOR

standard antiasthmatic therapy and omalizumab

Biological: omalizumab

oral tablet HDM-immunotherapy

ACTIVE COMPARATOR

standard antiasthmatic therapy and oral immunotherapy

Biological: omalizumab

combi therapy

ACTIVE COMPARATOR

standard antiasthmatic therapy and omalizumab, and oral immunotherapy

Biological: omalizumab

control

NO INTERVENTION

Interventions

omalizumab BIOLOGICAL

adding omalizumab to anti asthmatic therapy

combi therapy; omalizumab; oral tablet HDM-immunotherapy

Eligibility Criteria

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

You may qualify if:

• A total IgE between 30-700 IU/mL
• Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
• FEV1 \>70% at baseline;
• Positive skin prick test results for D. pteronyssinus, D. farinae

You may not qualify if:

• Sensitisation to other allergens with clinical signs not related to HDM
• Uncontrolled asthma,
• Other serious diseases or chronic unstable diseases
• Allergen immunotherapy during the past 5 years
• Contraindicating allergen immunotherapy and omalizumab treatment.

Sponsors & Collaborators

• Medical University of Silesia: lead
• Centrum Medyczne Andrzej Bożek: collaborator

Related Publications (1)

• Batard T, Taille C, Guilleminault L, Bozek A, Floch VB, Pfaar O, Canonica WG, Akdis C, Shamji MH, Mascarell L. Allergen Immunotherapy for the Prevention and Treatment of Asthma. Clin Exp Allergy. 2025 Feb;55(2):111-141. doi: 10.1111/cea.14575. Epub 2024 Oct 4.

  PMID: 39363801 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

Central Study Contacts

Andrzej Bozek, prof

CONTACT

0048608318547; andrzejbozek@o2.pl

Study Design

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

Model Details: The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows: Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share