A clinical study to investigate tregalizumab effects on allergen-induced airway responses and airway inflammation in asthmatic patients

Phase 1

• Conditions: mild controlled allergic asthma and house-dust mite (HDM) allergy; MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000585-41-DE
• Lead Sponsor: T-Balance Therapeutics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-15
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1.Willing and able to give written informed consent
2.Male or female subject aged 18 to 65 years (both inclusive).
3.Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
4.Body mass index (BMI) of 18.0 to 30.0 (both inclusive).
5.Non-smoker (all substances).
6.Specific IgE to HDM (Dermatophagoides farinae) = class 2 in radioallergosorbent test (RAST).
7.BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
8.FEV1 = 75% of predicted value (according to height, weight and sex).
9.Subject must demonstrate a significant EAR and LAR without rescue medication use within the first 7 hours after BAP. EAR is defined as a decrease in FEV1 of = 20% within 0 to 3 hours after allergen challenge; LAR is defined as a decrease in FEV1 of = 15% within 4 to 7 hours after BAP.
10.No clinically relevant abnormalities in 12-lead ECG at screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Severe, unstable bronchial asthma.
2.Exacerbation of asthma = 4 weeks prior to screening.
3.Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
4.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.
5.Current treatment with any immunosuppressants (e.g., monoclonal antibodies, methotrexate, cyclosporin).
6.Specific immunotherapy (SCIT) to mite within 3 years prior to screening.
7.Serious adverse drug reaction to previous biological treatment.
8.Previous therapy with a monoclonal antibody (mAb) targeting CD4, including tregalizumab.
9.Known hypersensitivity to any constituents of tregalizumab, and/or other mAbs, that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
10.Previous inclusion in this study.
11.Serum transaminases, alanine transaminase (ALAT) and/or aspartate transaminase (ASAT) > 2.5-fold upper level of normal (ULN) at screening.
12.Bilirubin > 34.2 µmol/L at screening.
13.Alkaline phosphatase (AP) > 2-fold ULN at screening.
14.Urea nitrogen > 1.5-fold ULN at screening.
15.Kidney insufficiency as defined by creatinine level > 133 µmol/L at screening.
16.History of severe allergic or anaphylactic reaction to proteins of human origin (e.g. vaccination reaction, biological therapy).
17.Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin).
18.Presence or history of clinically significant major disease (e.g., severe heart/lung disease New York Heart Association [NYHA] Class = 3, autoimmune disease [apart from rheumatoid arthritis], acute uncontrolled hyper- or hypo-thyroidism, severe uncontrolled hypo or hypertension).
19.Serious local (e.g., abscess) or systemic (e.g., pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period.
20.Any infection requiring antibiotic therapy by any route of administration within 4 weeks prior to screening.
21.Vaccination with live, live attenuated, and/or killed vaccines in the 12 weeks prior to the first administration of the study drug and during the study.
22.Positive diagnosis for acute or chronic infections (e.g. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at screening or history of previous chronic infection.
23.Acute or clinically symptomatic Epstein-Barr Virus (EBV) (infectious mononucleosis) or Cytomegalovirus (CMV) infection.
24.Presence or history of latent or active tuberculosis.
25.Known immune deficiency.
26.Presence or history of lymphoproliferative disease, including lymphoma and lymphadenopathy.
27.Presence or history of clinically significant drug or alcohol abuse.
28.Employee at study site or any institution involved in this study (including the sponsor), or spouse/partner or relative of an investigator.
29.Pregnant or nursing woman or woman considering to become pregnant during the study or in the 3 months after the last administration of study drug.
30.Woman of childbearing potential (unless surgically sterile or post-menopausal > 52 weeks) who is not using two (2) independent effective contraceptive methods (e.g., oral or injectable contraceptives, intra-uterine devices, double barrie

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified