Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients

NCT04673591 | Completed Phase 2

• 1 other identifier: OG-061-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted as a randomized, double-blind, placebo-controlled, single-center study in adult patients with mild controlled allergic asthma and house dust mite allergy.

Conditions

Allergy to House Dust Mite; Allergic Asthma

Keywords

Mild asthma; House Dust Mite; Allergy

Outcome Measures

Primary Outcomes (1)

• Baseline-corrected late asthmatic response measured by the area under the curve for the forced expiratory volume (FEV1) at 4 to 7 hours after bronchial allergen provocation

  Day 84

Secondary Outcomes (17)

• Change in late asthmatic response, as measured from 4 to 7 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values

  Baseline and Day 84

• Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values

  Baseline and Day 84

• Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the area under the curve of the normalized forced expiratory volume (FEV1) values

  Baseline and Day 84

• Fraction of eNO (FeNO) absolute levels and delta increase after bronchial allergen provocation

  Baseline and Day 84

• Dose of methacholine causing a decrease in forced expiratory volume (FEV1) of at least 20% (PD20)

  Baseline, Day 85, Day 112

Study Arms (2)

Tregalizumab

EXPERIMENTAL

Drug: Tregalizumab

Matched placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tregalizumab DRUG

a monoclonal antibody designed for the treatment of allergic asthma indication

Tregalizumab

Placebo OTHER

Matched Placebo

Matched placebo

Eligibility Criteria

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

You may qualify if:

• Willing and able to give written informed consent.
• Male or female subject aged 18 to 65 years (both inclusive).
• Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
• BMI of 18.0 to 30.0 (both inclusive).
• Non-smoker (all substances).
• Specific IgE to HDM (Dermatophagoides farinae) ≥ class 2 in radioallergosorbent test (RAST).
• BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
• FEV1 ≥ 75% of predicted value (according to height, weight and sex).
• Subject must demonstrate a significant EAR and LAR without rescue medication use within the first 7 hours after BAP.
• No clinically relevant abnormalities in 12-lead ECG at screening.

You may not qualify if:

• Severe, unstable bronchial asthma.
• Exacerbation of asthma ≤ 4 weeks prior to screening.
• Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
• Treatment with inhaled corticosteroids, methylxanthines (e.g., theophyllin), anticholinergics (e.g., ipratropium bromide), leukotriene modifiers (e.g., montelukast), tiotropium bromide, cromolyn or nedocromil within 2 weeks prior to screening and during the study.
• Current treatment with any immunosuppressants (e.g., monoclonal antibodies, methotrexate, cyclosporin).
• Specific immunotherapy (SCIT) to mite within 3 years prior to screening.
• Serious adverse drug reaction to previous biological treatment.
• Previous therapy with a mAb targeting CD4, including tregalizumab.
• Known hypersensitivity to any constituents of tregalizumab and/or other mAbs, that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
• Serum transaminases, ALAT and/or ASAT \> 2.5-fold ULN at screening.
• Bilirubin \> 34.2 µmol/L at screening.
• AP \> 2-fold ULN at screening.
• Urea nitrogen \> 1.5-fold ULN at screening.
• Kidney insufficiency as defined by creatinine level \> 133 µmol/L at screening.
• History of severe allergic or anaphylactic reaction to proteins of human origin (e.g. vaccination reaction, biological therapy).

Sponsors & Collaborators

• T-Balance Therapeutics GmbH: lead

Study Sites (1)

Medaimun GmbH

Frankfurt, Germany

Location

MeSH Terms

Conditions

Dust Mite Allergy; Hypersensitivity

Interventions

tregalizumab

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Stefan Zielen, Prof. Dr.

  Medaimun GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 17, 2020
• Study Start: December 9, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

DE (1)